Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Recruiting now · Phase 3

Conditions studied: Intracerebral Hemorrhage, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03907046

Run by

Yale University

People needed

700

Starts

2020-01-28

Expected to finish

2027-04-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PIH Health Hospital - Whittier — Whittier, California, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• University of Alabama Hospital — Birmingham, Alabama, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• University of South Alabama University Hospital — Mobile, Alabama, United States (enrolling)
• Arrowhead Regional Medical Center — Colton, California, United States (enrolling)
• San Francisco General Hospital — San Francisco, California, United States (enrolling)
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States (enrolling)
• Community Regional Medical Center of Fresno — Fresno, California, United States (enrolling)
• St. Jude Medical Center — Fullerton, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• Los Alamitos Medical Center — Los Alamitos, California, United States (enrolling)
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• Doctors Medical Center Modesto, Modesto, CA — Modesto, California, United States (enrolling)
• Banner University Medical Center — Tucson, Arizona, United States (enrolling)
• UC Irvine Medical Center — Orange, California, United States (enrolling)
• Desert Regional Medical Center — Palm Springs, California, United States (enrolling)
• Kaiser Permanente Fontana Medical Center — Fontana, California, United States (enrolling)
• Kaiser Permanente Redwood City Medical Center, Redwood City, CA — Redwood City, California, United States (enrolling)
• UC Davis Medical Center — Sacramento, California, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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