Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
a study on Stroke Atrial Fibrillation Heart Conditions
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
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.
Official Title
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Details
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.
Keywords
Intracerebral Hemorrhage Atrial Fibrillation Cerebral Hemorrhage Hemorrhage Aspirin Apixaban
Eligibility
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 14-120 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
You CAN'T join if...
- Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
- 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
Locations
- San Francisco General Hospital
accepting new patients
San Francisco California 94110 United States - Eden Medical Center, Castro Valley
accepting new patients
Castro Valley California 94546 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Yale University
- ID
- NCT03907046
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated
Frequently Asked Questions
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