Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

Compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

In order to participate you must meet the following criteria:

• Are at least 18 years of age.
• Have intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI.
• Can be randomized within 14-180 days after ICH onset.
• Have non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF.
• Have 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 will be excluded from the study if any of the following criteria apply to you:

• Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor.
• Have a history of earlier ICH within 12 months preceding index event.
• Have active infective endocarditis.
• Have 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).
• Have previous or planned left atrial appendage closure.
• Have clinically significant bleeding diathesis.
• Have serum creatinine ≥2.5 mg/dL.
• Have active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
• Have anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10^9/L) that is chronic in the judgment of the investigator.
• Are pregnant or breastfeeding.
• Have a known allergy to aspirin or apixaban.
• Have concomitant participation in a competing trial.
• Are considered by the investigator to have a condition that precludes safe or active participation in the trial.
• Have persistent, uncontrolled systolic blood pressure (≥180 mm Hg).
• Have ICH caused by an arteriovenous malformation (AVM) that has not yet been secured.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.