Home › Trials › NCT03907046

Comparing apixaban and aspirin for preventing strokes in ICH survivors with atrial fibrillation

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

PHASE3 · Yale University · NCT03907046

This study is testing if a blood thinner called apixaban works better than aspirin to prevent strokes or death in people who have had a brain bleed and also have atrial fibrillation.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorYale University (other)
Locations187 sites (Birmingham, Alabama and 186 other locations)
Trial IDNCT03907046 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether apixaban is more effective than aspirin in preventing strokes or death in patients who have recently experienced an intracerebral hemorrhage (ICH) and have atrial fibrillation. It is a randomized, double-blinded, phase III trial that will enroll 700 patients over 3.5 years, with follow-up lasting between 12 to 36 months. The primary outcome measures include any stroke (hemorrhagic or ischemic) or death, while secondary outcomes focus on functional recovery as assessed by the modified Rankin Scale. The study is coordinated through the NIH/NINDS StrokeNet network.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have had a recent ICH and are diagnosed with non-valvular atrial fibrillation.

Not a fit: Patients with a history of recent ICH, those requiring anticoagulation for other medical conditions, or those with active infective endocarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective anticoagulation treatment option for stroke prevention in ICH survivors with atrial fibrillation.

How similar studies have performed: Previous studies have explored anticoagulation in similar patient populations, but this specific comparison of apixaban versus aspirin in ICH survivors is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age at least 18 years
* Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
* Can be randomized within 14-180 days after ICH onset
* Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
* Provision of signed and dated informed consent form by patient or legally authorized representative
* For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

* Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
* History of earlier ICH within 12 months preceding index event
* Active infective endocarditis
* Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent).
* Previous or planned left atrial appendage closure
* Clinically significant bleeding diathesis
* Serum creatinine ≥2.5 mg/dL
* Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
* Anemia (hemoglobin \<8 g/dL) or thrombocytopenia (\<100 x 10\^9/L) that is chronic in the judgment of the investigator
* Pregnant or breastfeeding
* Known allergy to aspirin or apixaban
* Concomitant participation in a competing trial
* Considered by the investigator to have a condition that precludes safe or active participation in the trial
* Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
* ICH caused by an arteriovenous malformation (AVM) that has not yet been secured

Where this trial is running

Birmingham, Alabama and 186 other locations

+137 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Intracerebral Hemorrhage, Atrial Fibrillation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.