Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

About

Brief Summary

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.

Primary Purpose

Prevention

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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