Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

  • STATUS
    Recruiting
  • End date
    Apr 10, 2024
  • participants needed
    700
  • sponsor
    Yale University
Updated on 4 October 2022
Investigator
Kevin N Sheth, MD
Primary Contact
St. Cloud Hospital (2.1 mi away) Contact
+127 other location
aspirin
electrocardiogram
stroke
antiplatelet agents
fibrillation
intracerebral hemorrhage
brain ct
vascular disease
apixaban
atrial flutter
anticoagulation therapy
intraventricular hemorrhage

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.

Description

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 high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). 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.

Details
Condition Intracerebral Hemorrhage, Atrial Fibrillation
Treatment Aspirin, Apixaban
Clinical Study IdentifierNCT03907046
SponsorYale University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Considered by the investigator to have a condition that precludes safe or active participation in the trial
Known allergy to aspirin or apixaban
Concomitant participation in a competing therapeutic trial
Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
ICH caused by an arteriovenous malformation (AVM) that has not yet been secured
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