General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03907046

Background Information

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and non-valvular AF.

Offered At

Inova Fairfax Medical Campus
3300 Gallows Rd.
Falls Church, VA 22042

Eligibility Information

  • 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

Ineligibility Information

  • 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

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT03907046?term=ASPIRE&cond=stroke&draw=2&rank=3