A Phase 3 interventional study of Eliquis and No oral anticoagulation in Atrial Fibrillation, Atrial Flutter and End Stage Kidney Disease (ESRD), sponsored by Unity Health Toronto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Unity Health Toronto · Phase 3, Interventional, and Treatment
Among 31 studies testing apixaban in Atrial Fibrillation — 11 open to participants now, 12 under way, 4 of them phase 3. apixaban · Atrial Fibrillation.
Among the 31 studies testing apixaban in Atrial Fibrillation, this one is the 12th largest by planned enrollment, is one of 6 that started in 2026, is one of 12 in phase 3, reaches primary completion later than 9 of the 11 other live ones, and was the 30th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 848 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →11 of the 31 studies testing apixaban in Atrial Fibrillation are open now, in 10 countries. Each count lists the studies.
apixaban: first FDA approval 2012 (ELIQUIS), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 6 started in 2026.
Median enrollment 586 across the 31 interventional studies. Of the 17 that completed or were terminated, 9 (53%) have results posted.
6 of 31 have an industry lead sponsor. The 10 most frequent:
Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Unity Health Toronto has 4 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
2 of the studies testing apixaban in Atrial Fibrillation that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03907046Phase 3Yale UniversityAnticoagulation in ICH Survivors for Stroke Prevention and Recovery | 2027-04 |
| NCT03129490Herlev and Gentofte HospitalThe Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation | 2027-10-30 |
Among the 31 studies testing apixaban in Atrial Fibrillation, from their registry updates:
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.
Atrial fibrillation (AF) is common among people receiving maintenance dialysis and is associated with an increased risk of ischemic stroke, systemic embolism, cardiovascular events, and death. Although oral anticoagulation is recommended for many patients with AF in the general population, the benefits and risks of anticoagulation in people receiving dialysis remain uncertain because this population has been excluded from most pivotal randomized trials. Observational studies have reported conflicting findings, and current guideline recommendations differ, resulting in substantial variation in clinical practice.
The Strategies for the Management of Atrial Fibrillation in patiEnts receiving Dialysis 2 (SAFE-D2) trial is designed to address this important evidence gap. The study will evaluate whether a treatment strategy using apixaban is superior to a strategy of no oral anticoagulation for the prevention of ischemic stroke and systemic embolism in adults receiving maintenance hemodialysis or peritoneal dialysis who have non-valvular AF and an elevated risk of stroke.
SAFE-D2 is an investigator-initiated, international, multicenter, pragmatic, randomized, open-label trial with blinded adjudication of study outcomes. Approximately 848 participants will be randomly assigned in a 1:1 ratio to receive either apixaban or no oral anticoagulation, while continuing to receive standard dialysis and other routine medical care.
The trial is designed to determine whether apixaban reduces the risk of ischemic stroke or systemic embolism while evaluating the overall balance between potential benefits and harms. In addition to thromboembolic events, the study will assess mortality, cardiovascular events, bleeding complications, hospitalizations, dialysis vascular access thrombosis, and patient-reported health-related quality of life. An independent Clinical Events Committee, blinded to treatment allocation, will adjudicate all major efficacy and safety outcomes according to prespecified definitions.
SAFE-D2 builds on the feasibility established in the CIHR-funded SAFE-D pilot trial and reflects contemporary clinical practice by evaluating apixaban rather than warfarin. The results are expected to provide high-quality randomized evidence to inform clinical practice guidelines and support shared decision-making regarding stroke prevention in people receiving maintenance dialysis and atrial fibrillation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this trial, participants need to satisfy ALL these inclusion criteria:
A history of non-valvular AF or atrial flutter (AFL) defined as one of the following:
Exclusion Criteria
Potential participants must have NONE of the following exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Eliquis
Individuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
Other: No oral anticoagulation
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
Stroke or systemic embolism
The primary outcome is time to first confirmed ischemic stroke or systemic embolism.
Time frame: 5 years
Time to all-cause death
Time frame: 5 years
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
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
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
Time to first ischemic stroke
Time from randomization to the first adjudicated ischemic stroke.
Time frame: 5 years
Time to first systemic embolism
Time from randomization to the first adjudicated systemic embolism.
Time frame: 5 years
Time to cardiovascular death
Time frame: 5 years
Time to first myocardial infarction
Time frame: 5 years
Net clinical benefit defined as the composite of stroke, systemic embolism, or major bleeding (ISTH definition).
Time to first occurrence of ischemic stroke, systemic embolism, or major bleeding (ISTH definition).
Time frame: 5 years
Time to first dialysis vascular access thrombosis
Time from randomization to the first clinically adjudicated thrombosis of an arteriovenous fistula or graft requiring surgical or endovascular intervention, such as thrombectomy or angioplasty, or resulting in permanent access loss.
Time frame: 5 years
Time to first major bleeding event
Time from randomization to the first major bleeding event meeting International Society on Thrombosis and Haemostasis (ISTH) criteria.
Time frame: 5 years
Time to first major or clinically relevant non-major bleeding event
Time from randomization to the first occurrence of major bleeding or clinically relevant non-major bleeding according to ISTH definitions.
Time frame: 5 years
Time to first clinically relevant non-major bleeding event
Time from randomization to the first clinically relevant non-major bleeding event according to ISTH criteria.
Time frame: 5 years
Time to first intracranial hemorrhage
Time from randomization to the first adjudicated intracranial hemorrhage, including intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, or other primary intracranial hemorrhage confirmed by neuroimaging or autopsy.
Time frame: 5 years
Time to fatal bleeding
Time from randomization to the first fatal bleeding event.
Time frame: 5 years
Number of all-cause unplanned hospitalizations
Total number of all-cause unplanned hospitalizations occurring during study follow-up, including recurrent hospitalizations. An all-cause unplanned hospitalization is defined as any non-elective admission to an acute care hospital lasting ≥24 hours, regardless of cause. Elective or planned admissions or procedures, routine day procedures or outpatient visits not requiring overnight admission, protocol-mandated assessments, routine health evaluations, and admissions solely for social, administrative, or logistical reasons are excluded. Transfers between hospital units or facilities as part of the same episode of care are considered a single hospitalization.
Time frame: 5 years
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Apixaban