Ensayos clínicos

Inclusion Criteria: 

• Age at least 18 years.
• Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI.
• Can be randomized within 14-120 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.
• CHA2DS2-VASc score ≥ 2.
• Provision of signed and dated informed consent form by patient or legally authorized representative.
• Expected to comply with all study procedures and be available for duration of the study.
• 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 ICH before index event.
• Active infective endocarditis.
• Lobar ICH with cerebral amyloid angiopathy.
• 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 MI). 
• 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 therapeutic trial.
• Considered by the investigator to have a condition that precludes safe participation in the trial.
• Unwilling to discontinue prohibited medications.