Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Investigating Anticoagulation in Stroke Survivors with Intracerebral Hemorrhage
Lisa Nobel
Primary Investigator
Brief description of study
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.
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - The patient population for the ASPIRE trial will comprise of men and women with a qualifying ICH and documented non-valvular AF. The stroke research team in place at participating sites will identify patients with a diagnosis of ICH. Where available, queries of electronic record will be made periodically to identify new diagnoses of ICH. In addition, to identify patients who have been hospitalized in the preceding several months (to permit enrollment within the 180-day window), screening procedures may be implemented in internal medicine, cardiology, and neurology/vascular neurology clinics.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Intracerebral Hemorrhage, ICH, Brian Hemorrhae, Stroke, Non-valvular Atrial Fibrillation, AF
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Age: 18 years - 100 years
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Gender: All
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
- 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 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 10^9/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
This study investigates the use of anticoagulation in patients who have survived an intracerebral hemorrhage (ICH) and have non-valvular atrial fibrillation (AF). Atrial fibrillation is a condition where the heart beats irregularly, which can increase the risk of stroke. The purpose of this study is to compare the effectiveness and safety of an investigational medication with aspirin in preventing stroke or death in these patients.
Participants in the study will be randomly assigned to receive either the investigational medication or aspirin. The study is double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. Researchers will monitor outcomes such as the occurrence of stroke or death, and assess functional outcomes using the modified Rankin Scale. This scale measures the degree of disability or dependence in daily activities.
- Who can participate: Adults aged 18 and older with a confirmed intracerebral hemorrhage and non-valvular atrial fibrillation are eligible. Randomization must occur 14 to 180 days after the ICH event, excluding those with recent ICH, active endocarditis, and severe kidney or liver issues.
- Study details: Participants will take either the investigational medication or aspirin. The study is double-blinded, so neither participants nor researchers will know who receives which treatment.
