Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
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 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.
Inclusion Criteria:
Exclusion Criteria:
kevin.sheth@yale.edu443-615-4729
hok9010@med.cornell.edu646-962-8284
Birmingham, Alabama 35294, United States
Redwood City, California 94063, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Washington D.C., District of Columbia 20037, United States
Minneapolis, Minnesota 55455, United States
Saint Louis Park, Minnesota 55426, United States
Staten Island, New York 10305, United States
Chapel Hill, North Carolina 27514, United States
Springfield, Oregon 97477, United States
Charleston, South Carolina 29425, United States
San Antonio, Texas 78229, United States