Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis 2 (SAFE-D2)

Sponsor
Unity Health Toronto
Study ID
NCT07779746
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Eliquis — DRUG
    The default starting dose of apixaban is 5 mg twice daily. Dose reduction to 2.5 mg twice daily is mandatory for participants who meet either of the following criteria at baseline or at any point during follow-up: * Age ≥80 years * Dialysis target (dry) weight ≤60 kg
  • No oral anticoagulation — OTHER
    No oral anticoagulation

Study Details

People receiving dialysis are more likely to develop atrial fibrillation (AF), an irregular heartbeat that increases the risk of stroke. Blood-thinning medications (anticoagulants) are commonly used to prevent strokes in people with AF, but it is not known whether they are beneficial for people receiving dialysis because this group has not been well represented in previous clinical trials. As a result, healthcare providers do not have clear evidence to guide treatment decisions. The SAFE-D2 study will compare two approaches to preventing stroke in adults receiving maintenance hemodialysis or peritoneal dialysis who have non-valvular AF and are at increased risk of stroke. Participants will be randomly assigned (by chance) to receive either apixaban, an oral blood thinner, or no oral anticoagulant, while continuing to receive their usual dialysis and medical care. The main goal of the study is to determine whether apixaban is more effective than no oral anticoagulant at reducing the risk of stroke or blood clots traveling to other parts of the body (systemic embolism). The study will also compare the two approaches with respect to survival, heart-related complications, major bleeding and other bleeding events, hospitalizations, dialysis access complications, quality of life, and the overall balance of benefits and risks. Approximately 848 participants from Canada, Brazil, and Israel will take part in the study. The results of SAFE-D2 are expected to provide important evidence to help patients, families, and healthcare providers make informed decisions about stroke prevention for people receiving dialysis who have atrial fibrillation.

Key Dates

First listed
Aug 21, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2032

Study Design

Enrollment
848 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Apixiban
    The default starting dose of apixaban is 5 mg twice daily. Dose reduction to 2.5 mg twice daily is mandatory for participants who meet either of the following criteria at baseline or at any point during follow-up: * Age ≥80 years * Dialysis target (dry) weight ≤60 kg
  • Active Comparator: No oral anticoagulation
    Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.

Primary Outcome Measure

Stroke or systemic embolism [ Time Frame: 5 years ]

Central Contacts

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