Trial Number
015-20
Condition
Stroke
Participant Age Range
18 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery”
A substantial portion of intracerebral hemorrhage (ICH) survivors have atrial fibrillation/flutter (AF) and are at high risk for subsequent ischemic stroke. Although randomized clinical trials have established theeffectiveness of anticoagulant therapy for preventing ischemic stroke in patients with AF, these trials did not enroll ICH patients because of concern that a potential increase in risk for recurrent hemorrhagic strokes would offset any benefit. The Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke Prevention and Recovery (ASPIRE) study 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 nonvalvular AF.