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Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion) (EMANATE)

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ClinicalTrials.gov Identifier: NCT02100228
Recruitment Status : Completed
First Posted : March 31, 2014
Results First Posted : April 10, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Atrial Fibrillation
Interventions Drug: Apixaban
Drug: Parenteral heparin and/or oral Vitamin K antagonist
Enrollment 1500
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants. Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Period Title: Overall Study
Started 753 [1] 747 [2]
Completed 678 657
Not Completed 75 90
Reason Not Completed
Other             19             19
Administrative reason             0             1
Inclusion/Exclusion criteria not met             12             16
Non-compliance             0             3
Lost to Follow-up             0             1
Withdrawal by Subject             27             37
Adverse Event             16             12
Death             1             1
[1]
735 treated with Apixaban
[2]
721 treated with Usual Care
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) Total
Hide Arm/Group Description Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants. Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice. Total of all reporting groups
Overall Number of Baseline Participants 753 747 1500
Hide Baseline Analysis Population Description
Full analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 753 participants 747 participants 1500 participants
64.7  (12.19) 64.5  (12.76) 64.6  (12.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 753 participants 747 participants 1500 participants
Female
248
  32.9%
250
  33.5%
498
  33.2%
Male
505
  67.1%
497
  66.5%
1002
  66.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 753 participants 747 participants 1500 participants
Hispanic or Latino
8
   1.1%
9
   1.2%
17
   1.1%
Not Hispanic or Latino
100
  13.3%
99
  13.3%
199
  13.3%
Unknown or Not Reported
645
  85.7%
639
  85.5%
1284
  85.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 753 participants 747 participants 1500 participants
White
654
  86.9%
648
  86.7%
1302
  86.8%
Black or African American
21
   2.8%
20
   2.7%
41
   2.7%
Asian
78
  10.4%
76
  10.2%
154
  10.3%
Other
0
   0.0%
3
   0.4%
3
   0.2%
1.Primary Outcome
Title Number of Participants With Acute Stroke Event
Hide Description An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).
Time Frame Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 753 747
Measure Type: Number
Unit of Measure: participants
0 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Comments Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.
Type of Statistical Test Superiority
Comments This was a descriptive study, and there was no formal pre-defined hypothesis testing.
Statistical Test of Hypothesis P-Value 0.0151
Comments nominal p-value
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.0000
Confidence Interval (2-Sided) 95%
0.0000 to 0.6425
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Systemic Embolism Event
Hide Description Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.
Time Frame Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 753 747
Measure Type: Number
Unit of Measure: participants
0 0
3.Primary Outcome
Title Number of Participants With Major Bleeding Event
Hide Description Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.
Time Frame Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all treated participants (randomized participants who received at least one dose of study drug).
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 735 721
Measure Type: Number
Unit of Measure: participants
3 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Comments Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.
Type of Statistical Test Superiority
Comments This was a descriptive study, and there was no formal pre-defined hypothesis testing.
Statistical Test of Hypothesis P-Value 0.3378
Comments nominal p-value
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.4905
Confidence Interval (2-Sided) 95%
0.1046 to 2.0678
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With Clinically Relevant Non-Major Bleeding Events
Hide Description Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.
Time Frame Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all treated participants (randomized participants who received at least one dose of study drug).
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 735 721
Measure Type: Number
Unit of Measure: participants
11 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Comments Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.
Type of Statistical Test Superiority
Comments This was a descriptive study, and there was no formal pre-defined hypothesis testing.
Statistical Test of Hypothesis P-Value 0.6851
Comments nominal p-value
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8300
Confidence Interval (2-Sided) 95%
0.3433 to 1.8916
Estimation Comments [Not Specified]
5.Primary Outcome
Title Number of Participants With All Cause Death
Hide Description [Not Specified]
Time Frame Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 753 747
Measure Type: Number
Unit of Measure: participants
2 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Comments Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.
Type of Statistical Test Superiority
Comments This was a descriptive study, and there was no formal pre-defined hypothesis testing.
Statistical Test of Hypothesis P-Value >0.9999
Comments nominal p-value
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.9841
Confidence Interval (2-Sided) 95%
0.1866 to 53.9968
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to First Attempt of Cardioversion
Hide Description Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.
Time Frame Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants. Here, "N" (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 510 511
Median (Full Range)
Unit of Measure: days
2.0
(1 to 93)
2.0
(1 to 126)
7.Secondary Outcome
Title Number of Participants With Different Type of Cardioversion Events
Hide Description Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock.
Time Frame Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants. Here "N" signifies number of participants who were evaluable for this specified outcome measure.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 496 494
Measure Type: Number
Unit of Measure: participants
Electrical 461 464
Pharmacologic 35 30
8.Secondary Outcome
Title Number of Cardioversion Attempt of Participants
Hide Description Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission.
Time Frame Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 753 747
Measure Type: Number
Unit of Measure: participants
No Cardioversion Attempt 234 224
1 Cardioversion Attempt 488 496
More than 2 Cardioversion Attempts 31 27
9.Secondary Outcome
Title Number of Participants With Their Rhythm Status
Hide Description Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute).
Time Frame Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all treated participants (randomized participants who received at least one dose of study drug). Here "N" signifies number of participants who were evaluable for this specified outcome measure.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 719 712
Measure Type: Number
Unit of Measure: participants
Normal Sinus 1 2
Atrial Fibrillation 715 704
Atrial Flutter 3 6
10.Secondary Outcome
Title Duration of Hospital Stay of Participants
Hide Description Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.
Time Frame Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants. Here "N" signifies number of participants who were evaluable for this specified outcome measure.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 330 346
Median (Full Range)
Unit of Measure: hours
45.36
(0.4 to 747.0)
49.47
(0.6 to 709.6)
11.Secondary Outcome
Title Number of Participants Who Used Image Guidance Approach
Hide Description An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study.
Time Frame Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants.
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description:
Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Number of Participants Analyzed 753 747
Measure Type: Number
Unit of Measure: participants
383 399
Time Frame From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed
Adverse Event Reporting Description Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
 
Arm/Group Title Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Hide Arm/Group Description Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants. Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
All-Cause Mortality
Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/735 (0.14%)   3/721 (0.42%) 
Hide Serious Adverse Events
Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   100/735 (13.61%)   112/721 (15.53%) 
Blood and lymphatic system disorders     
HAEMORRHAGIC ANAEMIA * 1  1/735 (0.14%)  0/721 (0.00%) 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION * 1  2/735 (0.27%)  0/721 (0.00%) 
ANGINA PECTORIS * 1  2/735 (0.27%)  0/721 (0.00%) 
ARTERIOSCLEROSIS CORONARY ARTERY * 1  1/735 (0.14%)  0/721 (0.00%) 
ATRIAL FIBRILLATION * 1  27/735 (3.67%)  40/721 (5.55%) 
ATRIAL FLUTTER * 1  3/735 (0.41%)  6/721 (0.83%) 
ATRIAL THROMBOSIS * 1  0/735 (0.00%)  3/721 (0.42%) 
ATRIOVENTRICULAR BLOCK COMPLETE * 1  0/735 (0.00%)  1/721 (0.14%) 
ATRIOVENTRICULAR DISSOCIATION * 1  1/735 (0.14%)  0/721 (0.00%) 
BRADYCARDIA * 1  1/735 (0.14%)  0/721 (0.00%) 
CARDIAC FAILURE * 1  5/735 (0.68%)  7/721 (0.97%) 
CARDIAC FAILURE ACUTE * 1  1/735 (0.14%)  1/721 (0.14%) 
CARDIAC FAILURE CONGESTIVE * 1  9/735 (1.22%)  7/721 (0.97%) 
CARDIO-RESPIRATORY ARREST * 1  0/735 (0.00%)  1/721 (0.14%) 
CARDIOGENIC SHOCK * 1  2/735 (0.27%)  0/721 (0.00%) 
CONGESTIVE CARDIOMYOPATHY * 1  1/735 (0.14%)  0/721 (0.00%) 
CORONARY ARTERY DISEASE * 1  2/735 (0.27%)  6/721 (0.83%) 
CORONARY ARTERY STENOSIS * 1  1/735 (0.14%)  1/721 (0.14%) 
ISCHAEMIC CARDIOMYOPATHY * 1  0/735 (0.00%)  1/721 (0.14%) 
MITRAL VALVE INCOMPETENCE * 1  1/735 (0.14%)  0/721 (0.00%) 
MITRAL VALVE PROLAPSE * 1  0/735 (0.00%)  3/721 (0.42%) 
MYOCARDIAL ISCHAEMIA * 1  0/735 (0.00%)  1/721 (0.14%) 
PALPITATIONS * 1  1/735 (0.14%)  1/721 (0.14%) 
PERICARDIAL EFFUSION * 1  0/735 (0.00%)  1/721 (0.14%) 
PERICARDITIS CONSTRICTIVE * 1  1/735 (0.14%)  0/721 (0.00%) 
SINUS ARREST * 1  2/735 (0.27%)  1/721 (0.14%) 
SINUS NODE DYSFUNCTION * 1  2/735 (0.27%)  1/721 (0.14%) 
TACHYARRHYTHMIA * 1  0/735 (0.00%)  1/721 (0.14%) 
TACHYCARDIA * 1  1/735 (0.14%)  0/721 (0.00%) 
TACHYCARDIA INDUCED CARDIOMYOPATHY * 1  0/735 (0.00%)  1/721 (0.14%) 
TRICUSPID VALVE INCOMPETENCE * 1  1/735 (0.14%)  0/721 (0.00%) 
Congenital, familial and genetic disorders     
ADENOMATOUS POLYPOSIS COLI * 1  1/735 (0.14%)  0/721 (0.00%) 
HYPERTROPHIC CARDIOMYOPATHY * 1  1/735 (0.14%)  1/721 (0.14%) 
Endocrine disorders     
ADRENAL HAEMORRHAGE * 1  1/735 (0.14%)  0/721 (0.00%) 
TOXIC NODULAR GOITRE * 1  2/735 (0.27%)  0/721 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN UPPER * 1  0/735 (0.00%)  1/721 (0.14%) 
DUODENAL ULCER HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
ENTEROCOLITIS * 1  0/735 (0.00%)  1/721 (0.14%) 
FEMORAL HERNIA INCARCERATED * 1  0/735 (0.00%)  1/721 (0.14%) 
GASTRIC ULCER * 1  0/735 (0.00%)  1/721 (0.14%) 
GASTRITIS * 1  2/735 (0.27%)  0/721 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE * 1  2/735 (0.27%)  1/721 (0.14%) 
HAEMATEMESIS * 1  0/735 (0.00%)  1/721 (0.14%) 
HAEMATOCHEZIA * 1  0/735 (0.00%)  1/721 (0.14%) 
LARGE INTESTINE PERFORATION * 1  1/735 (0.14%)  0/721 (0.00%) 
MELAENA * 1  0/735 (0.00%)  1/721 (0.14%) 
MESENTERIC PANNICULITIS * 1  1/735 (0.14%)  0/721 (0.00%) 
OEDEMATOUS PANCREATITIS * 1  1/735 (0.14%)  0/721 (0.00%) 
OESOPHAGITIS * 1  0/735 (0.00%)  1/721 (0.14%) 
PEPTIC ULCER * 1  1/735 (0.14%)  0/721 (0.00%) 
PEPTIC ULCER HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
RECTAL HAEMORRHAGE * 1  1/735 (0.14%)  0/721 (0.00%) 
SMALL INTESTINAL OBSTRUCTION * 1  0/735 (0.00%)  1/721 (0.14%) 
General disorders     
ASTHENIA * 1  1/735 (0.14%)  0/721 (0.00%) 
CHEST PAIN * 1  0/735 (0.00%)  1/721 (0.14%) 
HERNIA * 1  1/735 (0.14%)  0/721 (0.00%) 
MUCOSAL HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
MULTIPLE ORGAN DYSFUNCTION SYNDROME * 1  1/735 (0.14%)  0/721 (0.00%) 
NON-CARDIAC CHEST PAIN * 1  3/735 (0.41%)  0/721 (0.00%) 
SUDDEN DEATH * 1  0/735 (0.00%)  1/721 (0.14%) 
Hepatobiliary disorders     
DRUG-INDUCED LIVER INJURY * 1  1/735 (0.14%)  0/721 (0.00%) 
HEPATIC CONGESTION * 1  1/735 (0.14%)  0/721 (0.00%) 
Immune system disorders     
DRUG HYPERSENSITIVITY * 1  0/735 (0.00%)  1/721 (0.14%) 
Infections and infestations     
ABSCESS LIMB * 1  1/735 (0.14%)  0/721 (0.00%) 
BRONCHITIS * 1  2/735 (0.27%)  0/721 (0.00%) 
CELLULITIS * 1  1/735 (0.14%)  1/721 (0.14%) 
ESCHERICHIA URINARY TRACT INFECTION * 1  1/735 (0.14%)  0/721 (0.00%) 
INFECTION * 1  0/735 (0.00%)  1/721 (0.14%) 
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE * 1  0/735 (0.00%)  1/721 (0.14%) 
INFLUENZA * 1  1/735 (0.14%)  0/721 (0.00%) 
INTESTINAL SEPSIS * 1  0/735 (0.00%)  1/721 (0.14%) 
LUNG INFECTION * 1  1/735 (0.14%)  0/721 (0.00%) 
PNEUMONIA * 1  3/735 (0.41%)  5/721 (0.69%) 
SEPSIS * 1  1/735 (0.14%)  0/721 (0.00%) 
SEPTIC SHOCK * 1  1/735 (0.14%)  0/721 (0.00%) 
URINARY TRACT INFECTION * 1  1/735 (0.14%)  1/721 (0.14%) 
UROSEPSIS * 1  0/735 (0.00%)  1/721 (0.14%) 
Injury, poisoning and procedural complications     
ARTERIAL BYPASS THROMBOSIS * 1  0/735 (0.00%)  1/721 (0.14%) 
EYE INJURY * 1  1/735 (0.14%)  0/721 (0.00%) 
FALL * 1  1/735 (0.14%)  0/721 (0.00%) 
FEMUR FRACTURE * 1  2/735 (0.27%)  0/721 (0.00%) 
HEAD INJURY * 1  1/735 (0.14%)  0/721 (0.00%) 
OVERDOSE * 1  0/735 (0.00%)  3/721 (0.42%) 
RADIUS FRACTURE * 1  1/735 (0.14%)  0/721 (0.00%) 
TOXICITY TO VARIOUS AGENTS * 1  1/735 (0.14%)  0/721 (0.00%) 
TRAUMATIC INTRACRANIAL HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
VASCULAR PSEUDOANEURYSM * 1  0/735 (0.00%)  1/721 (0.14%) 
Investigations     
COMPUTERISED TOMOGRAM CORONARY ARTERY ABNORMAL * 1  1/735 (0.14%)  0/721 (0.00%) 
FUNCTIONAL RESIDUAL CAPACITY DECREASED * 1  1/735 (0.14%)  0/721 (0.00%) 
HEPATIC ENZYME INCREASED * 1  1/735 (0.14%)  0/721 (0.00%) 
INTERNATIONAL NORMALISED RATIO ABNORMAL * 1  0/735 (0.00%)  1/721 (0.14%) 
INTERNATIONAL NORMALISED RATIO INCREASED * 1  1/735 (0.14%)  0/721 (0.00%) 
WEIGHT DECREASED * 1  0/735 (0.00%)  1/721 (0.14%) 
Metabolism and nutrition disorders     
DEHYDRATION * 1  1/735 (0.14%)  1/721 (0.14%) 
HYPOKALAEMIA * 1  0/735 (0.00%)  1/721 (0.14%) 
Musculoskeletal and connective tissue disorders     
FLANK PAIN * 1  1/735 (0.14%)  0/721 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ACUTE LEUKAEMIA * 1  0/735 (0.00%)  1/721 (0.14%) 
ADENOCARCINOMA * 1  1/735 (0.14%)  0/721 (0.00%) 
BREAST CANCER * 1  0/735 (0.00%)  1/721 (0.14%) 
ENDOMETRIAL CANCER * 1  0/735 (0.00%)  1/721 (0.14%) 
METASTASES TO BONE * 1  0/735 (0.00%)  1/721 (0.14%) 
PROSTATE CANCER * 1  0/735 (0.00%)  1/721 (0.14%) 
SQUAMOUS CELL CARCINOMA OF SKIN * 1  0/735 (0.00%)  1/721 (0.14%) 
Nervous system disorders     
BRAIN INJURY * 1  0/735 (0.00%)  1/721 (0.14%) 
CEREBRAL HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
CEREBRAL INFARCTION * 1  1/735 (0.14%)  1/721 (0.14%) 
CEREBROVASCULAR ACCIDENT * 1  1/735 (0.14%)  3/721 (0.42%) 
DEMENTIA * 1  1/735 (0.14%)  0/721 (0.00%) 
DIZZINESS * 1  0/735 (0.00%)  1/721 (0.14%) 
PRESYNCOPE * 1  1/735 (0.14%)  0/721 (0.00%) 
SEIZURE * 1  0/735 (0.00%)  1/721 (0.14%) 
SYNCOPE * 1  0/735 (0.00%)  2/721 (0.28%) 
TRANSIENT ISCHAEMIC ATTACK * 1  0/735 (0.00%)  2/721 (0.28%) 
Psychiatric disorders     
DEPRESSION * 1  1/735 (0.14%)  0/721 (0.00%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY * 1  1/735 (0.14%)  5/721 (0.69%) 
HAEMATURIA * 1  0/735 (0.00%)  1/721 (0.14%) 
POSTRENAL FAILURE * 1  0/735 (0.00%)  1/721 (0.14%) 
RENAL HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
Reproductive system and breast disorders     
VAGINAL HAEMORRHAGE * 1  0/735 (0.00%)  1/721 (0.14%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA * 1  1/735 (0.14%)  1/721 (0.14%) 
ATELECTASIS * 1  0/735 (0.00%)  1/721 (0.14%) 
DYSPNOEA * 1  3/735 (0.41%)  0/721 (0.00%) 
EPISTAXIS * 1  0/735 (0.00%)  1/721 (0.14%) 
MEDIASTINAL CYST * 1  1/735 (0.14%)  0/721 (0.00%) 
MEDIASTINAL HAEMATOMA * 1  0/735 (0.00%)  1/721 (0.14%) 
PLEURAL EFFUSION * 1  2/735 (0.27%)  1/721 (0.14%) 
PNEUMOTHORAX * 1  0/735 (0.00%)  1/721 (0.14%) 
PULMONARY CONGESTION * 1  3/735 (0.41%)  0/721 (0.00%) 
PULMONARY HYPERTENSION * 1  1/735 (0.14%)  0/721 (0.00%) 
PULMONARY OEDEMA * 1  1/735 (0.14%)  2/721 (0.28%) 
PULMONARY SARCOIDOSIS * 1  1/735 (0.14%)  0/721 (0.00%) 
RESPIRATORY FAILURE * 1  0/735 (0.00%)  1/721 (0.14%) 
Skin and subcutaneous tissue disorders     
DECUBITUS ULCER * 1  1/735 (0.14%)  0/721 (0.00%) 
DIABETIC FOOT * 1  0/735 (0.00%)  1/721 (0.14%) 
PETECHIAE * 1  1/735 (0.14%)  0/721 (0.00%) 
SUBCUTANEOUS EMPHYSEMA * 1  0/735 (0.00%)  1/721 (0.14%) 
Vascular disorders     
ARTERIAL HAEMORRHAGE * 1  1/735 (0.14%)  0/721 (0.00%) 
ARTERIOVENOUS FISTULA * 1  0/735 (0.00%)  1/721 (0.14%) 
HAEMATOMA * 1  0/735 (0.00%)  1/721 (0.14%) 
HYPERTENSION * 1  1/735 (0.14%)  0/721 (0.00%) 
HYPERTENSIVE CRISIS * 1  0/735 (0.00%)  2/721 (0.28%) 
HYPOTENSION * 1  1/735 (0.14%)  0/721 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Apixaban Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   70/735 (9.52%)   101/721 (14.01%) 
Cardiac disorders     
ATRIAL FIBRILLATION * 1  43/735 (5.85%)  46/721 (6.38%) 
ATRIAL THROMBOSIS * 1  17/735 (2.31%)  13/721 (1.80%) 
Investigations     
INTERNATIONAL NORMALISED RATIO ABNORMAL * 1  0/735 (0.00%)  19/721 (2.64%) 
INTERNATIONAL NORMALISED RATIO INCREASED * 1  0/735 (0.00%)  27/721 (3.74%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA * 1  15/735 (2.04%)  8/721 (1.11%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
The prioritization of outcome measures is not mentioned in the study documents (Statistical Analysis Plan and Protocol). The prioritization of outcome measures is based on team's discretion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100228    
Other Study ID Numbers: B0661025
CV185-267 ( Other Identifier: Alias Study Number )
2014-001231-36 ( EudraCT Number )
EMANATE ( Other Identifier: Alias Study Number )
First Submitted: February 5, 2014
First Posted: March 31, 2014
Results First Submitted: January 17, 2018
Results First Posted: April 10, 2018
Last Update Posted: May 23, 2018