What is the Purpose of this Study?
The purpose of this study is to compare the effects of a drug called apixaban to aspirin in patients with atrial fibrillation (irregular heart rate) and a recent brain hemorrhage to determine which is more effective for the prevention of future strokes. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive aspirin 81 milligrams once per day, plus a placebo (inactive) pill twice per day. Group 2 will receive apixaban 5 milligrams twice per day, plus a placebo pill once per day. Apixaban is approved by the U.S. Food and Drug Administration (FDA) for stroke prevention in patients with atrial fibrillation, but its use in this study is experimental.
Eligibility
- * 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
Show more
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
Show less
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Anticoagulation in Intracerebral Hemorrhage Survivors
for Stroke Prevention and Recovery