Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Apixaban; Aspirin

Criteria

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

• CHA2DS2-VASc score ≥ 2

• 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 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 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