RecruitingIntracerebral HemorrhageAtrial Fibrillation

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Eligible age

18+ yrs

Accepts

All genders

Locations

44 states

Healthy volunteers

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About this study

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Sponsor: Yale University

You may qualify if…

✓ 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

You may not qualify if…

✕ 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