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Trial record 1 of 1 for:    NCT01215253
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Ranolazine Implantable Cardioverter-Defibrillator Trial (RAID)

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ClinicalTrials.gov Identifier: NCT01215253
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : June 15, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Wojciech Zareba, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Heart Failure
Intervention Drug: Ranolazine
Enrollment 1012
Recruitment Details 1012 patients were recruited from 88 centers in the US and 7 centers in Canada
Pre-assignment Details  
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.

 Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Period Title: Overall Study
Started 510 502
Completed 424 439
Not Completed 86 63
Reason Not Completed
Withdrawal by Subject             57             35
Physician Decision             9             12
Lost to Follow-up             6             4
Other             14             12
Arm/Group Title Ranolazine Placebo Total
Hide Arm/Group Description

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.

 Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week. Total of all reporting groups
Overall Number of Baseline Participants 510 502 1012
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 510 participants 502 participants 1012 participants
64.3  (10.3) 64.2  (9.9) 64.3  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 510 participants 502 participants 1012 participants
Female
100
  19.6%
86
  17.1%
186
  18.4%
Male
410
  80.4%
416
  82.9%
826
  81.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 510 participants 502 participants 1012 participants
Hispanic or Latino
17
   3.3%
12
   2.4%
29
   2.9%
Not Hispanic or Latino
493
  96.7%
490
  97.6%
983
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 510 participants 502 participants 1012 participants
American Indian or Alaska Native
3
   0.6%
2
   0.4%
5
   0.5%
Asian
2
   0.4%
2
   0.4%
4
   0.4%
Native Hawaiian or Other Pacific Islander
1
   0.2%
0
   0.0%
1
   0.1%
Black or African American
85
  16.7%
85
  16.9%
170
  16.8%
White
404
  79.2%
410
  81.7%
814
  80.4%
More than one race
3
   0.6%
1
   0.2%
4
   0.4%
Unknown or Not Reported
12
   2.4%
2
   0.4%
14
   1.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 510 participants 502 participants 1012 participants
Canada
31
   6.1%
31
   6.2%
62
   6.1%
United States
479
  93.9%
471
  93.8%
950
  93.9%
1.Primary Outcome
Title Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death
Hide Description Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first.
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
174
  34.1%
198
  39.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.67 to 1.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With VT or VF Requiring ICD Shock or Death
Hide Description Implantable cardioverter-defibrillator (ICD) shock for VT or VF or death, whichever occurs first.
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
131
  25.7%
145
  28.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.891
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.76 to 1.26
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies
Hide Description Total number of recurrent ICD therapies requiring antitachycardia pacing (ATP) or shock will be analyzed, not just first event
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Overall Number of Units Analyzed
Type of Units Analyzed: VT/VF events
 741 986
Count of Units
Unit of Measure: VT/VF events
433
  58.4%
650
  65.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Anderson-Gill analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.51 to 0.96
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients With First Inappropriate ICD Shock
Hide Description Number of patients with first inappropriate ICD shock for other reasons than VT or VF
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
16
   3.1%
20
   4.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.398
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.38 to 1.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First.
Hide Description Number of patients with a composite endpoint of cardiovascular hospitalization or death, whichever occurred first.
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
237
  46.5%
222
  44.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.91 to 1.34
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First
Hide Description Number of patients with a composite endpoint of heart failure hospitalization or death, whichever occurred first.
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
144
  28.2%
140
  27.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.577
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.84 to 1.37
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Death
Hide Description Death as a safety endpoint of the trial
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
70
  13.7%
78
  15.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.69 to 1.37
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Meters Walked in 6 Minutes
Hide Description Exercise capacity measured by the 6-minute walk test
Time Frame 1 year of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on 86 patients in the placebo arm and 99 patients in the Ranolazine arm.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 325 353
Mean (Standard Deviation)
Unit of Measure: meters
314  (127.5) 309  (123.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method nonparametric Wilcoxon rank-sum test
Comments [Not Specified]
9.Secondary Outcome
Title Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide Description The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. The scale ranges from 0-100 with lower scores indicating worse outcomes.
Time Frame 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 42 patients in the placebo arm and 61 patients in the Ranolazine arm.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 363 397
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.6  (24.1) 72.8  (24.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments [Not Specified]
Method nonparametric Wilcoxon rank-sum test
Comments [Not Specified]
10.Secondary Outcome
Title Number of Recurrent Inappropriate ICD Shocks
Hide Description Number of recurrent inappropriate ICD shocks in all patients combined.
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Number
Unit of Measure: events
19 26
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments [Not Specified]
Method Anderdon-Gill analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.36 to 1.52
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP)
Hide Description Number of patients whose first VT or VF required antitachycardia pacing (ATP)
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
92
  18.0%
117
  23.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.55 to 0.98
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Number of Patients Whose First VT/VF Required ICD Shock
Hide Description number of patients whose first VT or VF required ICD shock
Time Frame 2 years of follow-up on average
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Overall Number of Participants Analyzed 510 502
Measure Type: Count of Participants
Unit of Measure: Participants
79
  15.5%
84
  16.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.73 to 1.41
Estimation Comments [Not Specified]
Time Frame approximately 2 years (median 27 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description

At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose. For patients with CrCl <60ml/min prior to randomization, their CrCl will be checked again at 2 weeks and study drug discontinued if <30ml/min. For patients with CrCl <60ml/min at 2 weeks, their CrCl will be checked again at 4 weeks and study drug discontinued if <30ml/min.

Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.

 Ranolazine: At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
All-Cause Mortality
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   70/510 (13.73%)   78/502 (15.54%) 
Hide Serious Adverse Events
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/510 (0.00%)   0/502 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   69/510 (13.53%)   17/502 (3.39%) 
Gastrointestinal disorders     
nausea *  30/510 (5.88%)  6/502 (1.20%) 
General disorders     
dizziness *  39/510 (7.65%)  11/502 (2.19%) 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wojciech Zareba
Organization: University of Rochester
Phone: 585-275-5391
EMail: wojciech.zareba@heart.rochester.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wojciech Zareba, University of Rochester
ClinicalTrials.gov Identifier: NCT01215253    
Other Study ID Numbers: U01HL096607 ( U.S. NIH Grant/Contract )
First Submitted: September 30, 2010
First Posted: October 6, 2010
Results First Submitted: May 24, 2018
Results First Posted: June 15, 2018
Last Update Posted: August 27, 2018