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Phase III

Anticoagulation for Stroke Prevention and Recovery After ICH (ASPIRE

  • Study HIC#:2000026409
  • Last Updated:07/15/2021

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.

  • Age18 years and older
  • GenderBoth
  • Start Date02/27/2020
  • End Date04/29/2024

Trial Purpose and Description

Inclusion Criteria:

  • Age at least 18 years
  • Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
  • Can be randomized within 14-120 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
  • Able to comply with all study procedures and available for duration of the study
  • For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

  • History of ICH before index event
  • Active infective endocarditis
  • Lobar ICH with cerebral amyloid angiopathy
  • 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 109/L) that is chronic in the judgment of the investigator
  • Life expectancy <1 year
  • 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 participation in the trial
  • Unwilling to discontinue prohibited medications

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 14-120 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
  • Able to comply with all study procedures and available for duration of the study
  • For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

  • History of ICH before index event
  • Active infective endocarditis
  • Lobar ICH with cerebral amyloid angiopathy
  • 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 109/L) that is chronic in the judgment of the investigator
  • Life expectancy <1 year
  • 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 participation in the trial
  • Unwilling to discontinue prohibited medications