Apixaban vs Aspirin for Stroke Prevention After ICH

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Recruiting Phase 3 Interventional Study
Intracerebral Hemorrhage Atrial Fibrillation
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
700 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for

This trial is looking for adults who have had a recent brain bleed and have atrial fibrillation. Participants will compare the effects of a medication called apixaban with aspirin to see which better prevents strokes or death.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old
  • I have had a brain bleed confirmed by medical imaging
  • I can join the trial 14 to 180 days after my brain bleed
  • I have non-valvular atrial fibrillation
  • I can provide signed consent to participate
  • If I am a woman, I use effective contraception

You may not be able to join if

  • I have had another brain bleed in the past 12 months
  • I have active heart valve infection
  • I need blood thinners or antiplatelet drugs for other conditions
  • I have serious bleeding issues
  • I have a severe kidney problem
  • I am pregnant or breastfeeding
  • I am allergic to aspirin or apixaban
  • I have uncontrolled high blood pressure

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility 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 electr…
Contacts

Kevin N Sheth, MD

443-615-4729

kevin.sheth@yale.edu

CONTACT

Hooman Kamel, MD

646-962-8284

hok9010@med.cornell.edu

CONTACT