Health TrialsbyHealthPanel

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

ConditionsAtrial FibrillationAtrial FlutterEnd Stage Kidney Disease (ESRD)Dialysis Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years,

Kidney failure treated with hemodialysis or peritoneal dialysis for at least 90 days,

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    No oral anticoagulation

Treatment groups

848 Participants
are divided into 2 treatment groups
Group A: ApixibanActive comparator 1 intervention
Group B: No oral anticoagulationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stroke or systemic embolism

The primary outcome is time to first confirmed ischemic stroke or systemic embolism.

Time frame
5 years

Secondary outcomes

1

Time to all-cause death

Time frame
5 years
2

Time to first occurrence of ischemic stroke, systemic embolism, or all-cause death

Time from randomization to the first occurrence of confirmed ischemic stroke, systemic embolism, or death from any cause.

Time frame
5 years
3

Time to first occurrence of ischemic stroke, systemic embolism, or cardiovascular death

Time from randomization to the first occurrence of confirmed ischemic stroke, systemic embolism, or cardiovascular death.

Time frame
5 years
4

Time to first occurrence of ischemic stroke, systemic embolism, myocardial infarction, or all-cause death

Time from randomization to the first occurrence of confirmed ischemic stroke, systemic embolism, myocardial infarction, or death from any cause.

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: