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Anticoagulation for Stroke Prevention After Intracerebral Hemorrhage

This study is investigating if a blood thinner called apixaban is better than aspirin at preventing strokes or death in people who have recently experienced an intracerebral hemorrhage (ICH), which is bleeding in the brain. You may be able to join if you are at least 18 years old, have had an ICH confirmed by a brain scan, and also have atrial fibrillation (AF), an irregular heartbeat. The study aims to see if apixaban can improve your chances of avoiding another stroke or death, and also if it leads to better recovery and daily function compared to aspirin. The study plans to enroll 700 participants, but its current status is unclear.

Study design
This is a randomized, double-blinded study, meaning participants are assigned to either apixaban or aspirin by chance, and neither you nor your doctor will know which treatment you are receiving. It plans to enroll 700 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for study outcomes for a minimum of 12 months and a maximum of 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03907046

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Recruiting
PHASE3Ages 18+InterventionalPrevention
Yale University
~700 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:ApixabanAspirin

At a glance

Recruiting sites
142 of 187 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stroke or death
Measured over Up to 3 years

Conditions

Intracerebral Hemorrhage
Atrial Fibrillation

Explore related trials

Atrial FibrillationCerebral Hemorrhage

Where it's being run

187 sites across 44 states
California24
New York20
Illinois10
Florida9
North Carolina9
Michigan8
Ohio8
Pennsylvania8

Study leadership

  • Kevin N Sheth, MD · PRINCIPAL_INVESTIGATOR · Yale University
  • Hooman Kamel, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Kevin N Sheth, MD
[email protected]
443-615-4729
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Stroke or deathUp to 3 years

    Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause