Comparing apixaban and aspirin for preventing strokes in ICH survivors with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate whether apixaban is more effective than aspirin in preventing strokes or death in patients who have recently experienced an intracerebral hemorrhage (ICH) and have atrial fibrillation. It is a randomized, double-blinded, phase III trial that will enroll 700 patients over 3.5 years, with follow-up lasting between 12 to 36 months. The primary outcome measures include any stroke (hemorrhagic or ischemic) or death, while secondary outcomes focus on functional recovery as assessed by the modified Rankin Scale. The study is coordinated through the NIH/NINDS StrokeNet network.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama Hospital
  Birmingham, Alabama, United States Recruiting
• University of South Alabama University Hospital
  Mobile, Alabama, United States Recruiting
• Banner University Medical Center
  Tucson, Arizona, United States Recruiting
• Mercy San Juan Medical Center
  Carmichael, California, United States Recruiting
• Arrowhead Regional Medical Center
  Colton, California, United States Recruiting
• Kaiser Permanente Fontana Medical Center
  Fontana, California, United States Recruiting

+137 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Kevin N Sheth, MD — Yale University
• Study coordinator: Kevin N Sheth, MD
• Email: kevin.sheth@yale.edu
• Phone: 443-615-4729

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.