Can a blood thinner cut stroke risk in dialysis patients?

NCT ID NCT07779746

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether apixaban, a blood thinner, can reduce the risk of stroke or blood clots in adults on dialysis who also have atrial fibrillation (an irregular heartbeat). Participants are randomly assigned to receive either apixaban or no oral anticoagulant, while continuing their usual dialysis care. The study aims to provide clear evidence on the best approach for stroke prevention in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apixaban (an oral blood thinner)
What this could lead to
If apixaban proves effective, it could provide a clear, evidence-based option to prevent strokes in dialysis patients with atrial fibrillation, a group often excluded from prior trials.
What could go wrong
This is a large trial, but results may not show a clear benefit over no anticoagulant, and apixaban carries a risk of major bleeding, especially in dialysis patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 848 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria To be eligible to participate in this trial, participants need to satisfy ALL these inclusion criteria: 1. Age ≥18 years, 2. Kidney failure treated with hemodialysis or peritoneal dialysis for at least 90 days, 3. A history of non-valvular AF or atrial flutter (AFL) defined as one of the following: 1. AF/AFL on an ECG at enrollment. 2. ≥2 episodes of AF/AFL on cardiac diagnostics with each episode lasting ≥30 seconds and occurring ≥24 hours apart. 3. One episode of AF/AFL on cardiac diagnostics lasting ≥30 seconds, plus ≥1 separate documented episode in the medical record. 4. 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 5. AF/AFL documented on one occasion in a cardiologist report. 4. Meet the CHA2DS2-VASc criteria (i.e. ≥2 for men and ≥3 for women) Exclusion Criteria Potential participants must have NONE of the following exclusion criteria: 1. Mitral stenosis described as moderate or severe. 2. Anticoagulation indicated for a reason other than atrial fibrillation. 3. Receipt of aspirin at a dose of \>160 mg daily. 4. Ongoing requirement at screening for a strong CYP3A4/P-gp inhibitor or inducer that cannot be discontinued, substituted, or otherwise managed safely. 5. 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. 6. Known clinically significant coagulopathy, or other bleeding risk that, in the judgment of the treating physician, renders oral anticoagulation unsafe. 7. A major bleeding event in the 30 days prior to study enrollment, or any active and clinically significant bleeding. 8. Current pregnancy or breastfeeding. 9. Anticipated life expectancy \< 6 months. 10. A scheduled live donor kidney transplant in the next 6 months. 11. 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 12. 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. 13. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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