Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis 2 (SAFE-D2)
NCT07779746Sponsor: Unity Health Toronto
Principal investigator
Patients can be seen at: University Hospital, Kidney Care Centre - Dialysis
About This Study
SAFE-D2 evaluates whether apixaban reduces ischemic stroke or systemic embolism compared with no oral anticoagulation in adults receiving maintenance hemodialysis or peritoneal dialysis who have nonvalvular AF and elevated stroke risk. Participants are randomized to apixaban or no oral anticoagulant while continuing usual dialysis and medical care. The trial also assesses mortality, cardiovascular events, bleeding, hospitalizations, dialysis access thrombosis, and health-related quality of life.
Who Can Participate?
✓ Inclusion Criteria
- •To be eligible to participate in this trial, participants need to satisfy ALL these
- •Age ≥18 years,
- •Kidney failure treated with hemodialysis or peritoneal dialysis for at least 90 days,
- •A history of non-valvular AF or atrial flutter (AFL) defined as one of the following:
- •AF/AFL on an ECG at enrollment.
- •≥2 episodes of AF/AFL on cardiac diagnostics with each episode lasting ≥30 seconds and occurring ≥24 hours apart.
- •One episode of AF/AFL on cardiac diagnostics lasting ≥30 seconds, plus ≥1 separate documented episode in the medical record.
- •One episode of AF (reported by cardiac diagnostics or documented in the medical record) plus treatment with an oral anticoagulant for stroke prevention as a result of AF/AFL; or
- •AF/AFL documented on one occasion in a cardiologist report.
- •Meet the CHA2DS2-VASc criteria (i.e. ≥2 for men and ≥3 for women)
✗ Exclusion Criteria
- •Potential participants must have NONE of the following
- •Mitral stenosis described as moderate or severe.
- •Anticoagulation indicated for a reason other than atrial fibrillation.
- •Receipt of aspirin at a dose of >160 mg daily.
- •Ongoing requirement at screening for a strong CYP3A4/P-gp inhibitor or inducer that cannot be discontinued, substituted, or otherwise managed safely.
- •Ongoing requirement for dual antiplatelet therapy at the time of screening that, in the judgement of the treating clinician, is expected to remain necessary after randomization and cannot be safely de-escalated to single antiplatelet therapy in the event of randomization to apixaban.
- •Known clinically significant coagulopathy, or other bleeding risk that, in the judgment of the treating physician, renders oral anticoagulation unsafe.
- •A major bleeding event in the 30 days prior to study enrollment, or any active and clinically significant bleeding.
- •Current pregnancy or breastfeeding.
- •Anticipated life expectancy < 6 months.
- •A scheduled live donor kidney transplant in the next 6 months.
- •Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the SAFE-D2 treatment strategies
- •The treating clinical team has determined that long-term OAC is clearly indicated such that randomization to the no OAC strategy would not be clinically acceptable.
- •The treating clinical team has determined that long-term OAC is clearly contraindicated such that randomization to the apixaban strategy would not be clinically acceptable.