IRB Study Number 2019-0136-164
Status Recruiting
Phase Phase 3
Location Tradition Hospital
Institute Neurological Institute
Description
The primary aim of this study is 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 AF.
Inclusion Criteria
The patient population for the ASPIRE trial will comprise men and women with a qualifying ICH and documented non-valvular AF.
Patients are eligible if all criteria below is met at the time of screening:
- 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 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
Patients will be excluded from screening if any of the following criteria is met:
- Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
- History of an earlier ICH within 12 months preceding index event
- Active infective endocarditis
- Clear indication for anticoagulant drug
- Previous or planned left atrial appendage closure
- Active hepatitis or hepatic insufficiency
- Anemia or thrombocytopenia
- Known allergy to aspirin or apixaban
- Persistent, uncontrolled systolic blood pressure
