NCT03907046.

Study name	Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)
Methods	Design: randomised controlled parallel group quadruple blind trial Setting: multicentre at NIH/NINDS StrokeNet sites in the USA Dates: January 2020‐April 2024
Participants	Inclusion criteria Age at least 18 years ICH (including spontaneous intraventricular haemorrhage) confirmed by brain CT or MRI Can be randomised 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 authorised representative Able to comply with all study procedures and available for duration of the study For females of reproductive potential: use of highly effective contraception Exclusion criteria 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 myocardial infarction) Previous or planned LAAO Clinically significant bleeding diathesis Serum creatinine ≥ 2.5 mg/dL Active hepatitis or hepatic insufficiency with Child‐Pugh score B or C Anaemia (haemoglobin < 8 g/dL) or thrombocytopaenia (< 100 x 109/L) that is chronic in the judgment of the investigator Life expectancy < 1 year 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
Interventions	Intervention: apixaban 5mg twice daily, or 2.5mg twice daily in the setting of ≥ 2 of the following: age ≥ 80 years, body weight ≤6 0 kg, or serum creatinine 1.5‐2.4 mg/dL, or patient is taking a strong CYP3A4/pGP inhibitor (e.g. ketoconazole, itraconazole, ritonavir, or clarithromycin) Comparator: aspirin 81mg once daily
Outcomes	Primary outcome Stroke of any type (ischaemic or haemorrhagic) or death from any cause Secondary outcome mRS score at 12 months Duration: 12‐36 months.
Starting date	28 January 2020
Contact information	Kevin N Sheth (kevin.sheth@yale.edu), Hooman Kamel (hok9010@med.cornell.edu)
Notes	Declarations of interest: not specified in trials register Sources of funding: not specified in trials register