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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
700
Stroke or death
Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause
Time frame: Up to 3 years
Modified Rankin Scale (mRS) score
Measure of neurologic disability (0=no disability to 6=dead)
Time frame: Change from baseline to 12 months; change over duration of follow-up
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University of Alabama Hospital
Birmingham, Alabama, United States
RECRUITINGUniversity of South Alabama University Hospital
Mobile, Alabama, United States
RECRUITINGChandler Regional Medical Center
Chandler, Arizona, United States
WITHDRAWNSt. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
WITHDRAWNBanner University Medical Center
Tucson, Arizona, United States
RECRUITINGUAMS Medical Center
Little Rock, Arkansas, United States
WITHDRAWNMercy San Juan Medical Center
Carmichael, California, United States
RECRUITINGEden Medical Center, Castro Valley
Castro Valley, California, United States
WITHDRAWNArrowhead Regional Medical Center
Colton, California, United States
RECRUITINGRancho Los Amigos National Rehabilitation Center
Downey, California, United States
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