Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D)
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ClinicalTrials.gov Identifier: NCT03987711 |
Recruitment Status :
Completed
First Posted : June 17, 2019
Last Update Posted : June 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Atrial Fibrillation End Stage Renal Failure on Dialysis | Drug: Warfarin Drug: Apixaban Other: No oral anticoagulation | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 151 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D) |
Actual Study Start Date : | December 10, 2019 |
Actual Primary Completion Date : | December 31, 2022 |
Actual Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Warfarin
Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
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Drug: Warfarin
Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
Other Name: Coumadin |
Active Comparator: Apixaban
Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
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Drug: Apixaban
Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
Other Name: Eliquis |
Active Comparator: No oral anticoagulation
Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
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Other: No oral anticoagulation
No oral anticoagulation |
- Recruitment of the target population within 2 years [ Time Frame: 2 years from start of trial ]
- At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period. [ Time Frame: 26 weeks ]
- Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%. [ Time Frame: 26 weeks ]
- >95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter [ Time Frame: End of trial ]Through adjudication of ECGs or other cardiac diagnostics
- Major bleeding [ Time Frame: 26 weeks ]As defined by the International Society of Thrombosis and Haemostasis (ISTH)
- Clinically relevant non-major bleeding [ Time Frame: 26 weeks ]As defined by the International Society of Thrombosis and Haemostasis (ISTH)
- Stroke and systemic embolism [ Time Frame: 26 weeks ]
- All cause mortality [ Time Frame: 26 weeks ]
- Non-fatal myocardial infarction [ Time Frame: 26 weeks ]
- Vascular events not related to dialysis access [ Time Frame: 26 weeks ]
- Events of special interest related to dialysis access, the dialysis procedure or the oral anticoagulants [ Time Frame: 26 weeks ]Thrombosis of fistula or graft; fistula or graft abandonment; thrombosis of dialysis catheter; red blood cell transfusions; calciphylaxis
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years.
- Receiving maintenance hemodialysis or peritoneal dialysis for > 90 days.
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History of AF or atrial flutter as defined by:
(i) AF or atrial flutter on a 12 lead ECG at enrollment, and not due to a reversible cause, or (ii) AF or atrial flutter documented on two separate occasions, not due to a reversible cause, at least 1 day apart prior to enrollment. AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or (iii) AF or atrial flutter documented on one occasion, not due to a reversible cause, prior to enrollment and being treated with an oral anticoagulant for AF or atrial flutter at enrollment. [AF or atrial flutter may be documented by ECG, or as an episode lasting at least 30 seconds on a rhythm strip or Holter recording, or more than 30 minutes if using pacemaker or implantable cardioverter defibrillator (ICD) recordings, or mentioned in the medical record], or (iv) AF or atrial flutter documented on one occasion on ECG, not due to a reversible cause, prior to enrollment and at least one more episode of AF or atrial flutter mentioned in the medical record, or (v) AF or atrial flutter documented on one occasion in a cardiologist report, not due to a reversible condition, prior to enrollment.
- Satisfying CHADS-65 criteria: i) Age ≥65 or ii) Age <65 and one of: hypertension, diabetes mellitus, congestive heart failure, stroke/transient ischemic attack or peripheral embolism.
Exclusion Criteria:
- Moderate or severe mitral stenosis.
- Conditions other than non-valvular atrial fibrillation that require oral anticoagulation, such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism.
- Need for aspirin at a dose > 165 mg a day, or need for aspirin in combination with P2Y12 antagonist therapy.
- Need for an interacting drug which precludes the safe use of apixaban.
- Life expectancy < 6 months.
- Scheduled live-donor kidney transplant in the next 6 months.
- A woman who is pregnant or breastfeeding or unwilling to pursue methods of contraception if < 12 months since the last menstrual period.
- Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein.
- Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely mandated.
- Patient's attending physician(s) (e.g., nephrologist and/or cardiologist and/or neurologist) believes that oral anticoagulation is absolutely contraindicated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987711
Principal Investigator: | Ziv Harel | Unity Health Toronto | |
Principal Investigator: | Ron Wald | Unity Health Toronto |
Responsible Party: | Unity Health Toronto |
ClinicalTrials.gov Identifier: | NCT03987711 |
Other Study ID Numbers: |
SAFE-D-01 |
First Posted: | June 17, 2019 Key Record Dates |
Last Update Posted: | June 22, 2023 |
Last Verified: | June 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Failure, Chronic Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Renal Insufficiency Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |
Renal Insufficiency, Chronic Chronic Disease Disease Attributes Warfarin Apixaban Anticoagulants Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |