Open Actively Recruiting

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

About

Brief 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.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
19-002068
Category
Neurology
Urology
Contact
Ileana Grunberg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03907046
For detailed technical eligibility, visit ClinicalTrials.gov.