for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
completion around



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.

Official Title

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery


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. Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.


Intracerebral Hemorrhage, Atrial Fibrillation, Cerebral Hemorrhage, Hemorrhage, Aspirin, Apixaban


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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 109/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


  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Hoag Hospital Newport Beach withdrawn
    Newport Beach California 92663 United States
  • Los Alamitos Medical Center accepting new patients
    Los Alamitos California 90720 United States
  • Long Beach Memorial Medical Center withdrawn
    Long Beach California 90806 United States
  • Rancho Los Amigos National Rehabilitation Center currently not accepting new patients, but might later
    Downey California 90242 United States
  • PIH Health Hospital - Whittier accepting new patients
    Whittier California 90602 United States
  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States


accepting new patients
Start Date
Completion Date
Yale University
Phase 3 research study
Study Type
Expecting 700 study participants
Last Updated