Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
a study on Hemorrhagic Stroke Intracranial Hemorrhage Stroke Atrial Fibrillation Heart Conditions
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedcompletion around
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 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.
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 14-180 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
Locations
- Ronald Reagan UCLA Medical Center
accepting new patients
Los Angeles California 90095 United States - Cedars-Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States - Kaiser Permanente Los Angeles Medical Center
accepting new patients
Los Angeles California 90027 United States - Huntington Memorial Hospital
accepting new patients
Pasadena California 91105 United States - Rancho Los Amigos National Rehabilitation Center
currently not accepting new patients, but might later
Downey California 90242 United States - Long Beach Memorial Medical Center
withdrawn
Long Beach California 90806 United States - PIH Health Hospital - Whittier
accepting new patients
Whittier California 90602 United States - Los Alamitos Medical Center
accepting new patients
Los Alamitos California 90720 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Yale University
- Links
- Sign up for this study
- ID
- NCT03907046
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 700 study participants
- Last Updated
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