Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
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.
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.
|
|
-
Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
|
-
Randomization permitted up to 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
|
-
Able to comply with all study procedures and available for duration of the study
|
-
For females of reproductive potential: use of highly effective contraception
|
-
Patients may have a prior history of ICH before the index event as long as the earlier event was more the 12 months before qualifying ICH
|
-
All patients with Lobar ICH may be enrolled
|
- 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 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
|
-
Please contact study team for additional inclusion/exclusion criteria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
Central Nervous System Diseases
|
|
|
-
Cerebrovascular Disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Neurology (Neurological Disorders)
|