Can a blood thinner cut stroke risk in dialysis patients?
NCT ID NCT07779746
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 848 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can dropping one blood thinner cut bleeding without raising heart risks?
- Hidden heart rhythm problems after stroke: can longer monitoring prevent a second stroke?
- Can a blood test reveal why atrial fibrillation returns after cryoablation?