Anticoagulation for Stroke Prevention and Recovery After ICH (ASPIRE)

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and non-valvular AF. Seven hundred patients will be enrolled and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.

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 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 an earlier ICH within 12 months preceding index event
• Active infective endocarditis
• Clear indication for anticoagulant drugs (e.g., requires anticoagulation for DVT or PE) 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 109/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

Patient may be enrolled if exclusion resolves within 180 days of index ICH (e.g., blood pressure is controlled, AVM secured).