Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Yale University
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 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 transform…
Interventions
- DrugApixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
- DrugAspirin
Aspirin is an oral antiplatelet drug.
Locations (187)
- University of Alabama HospitalBirmingham, Alabama
- University of South Alabama University HospitalMobile, Alabama
- Chandler Regional Medical CenterChandler, Arizona
- St. Joseph's Hospital and Medical CenterPhoenix, Arizona
- Banner University Medical CenterTucson, Arizona
- UAMS Medical CenterLittle Rock, Arkansas