Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
History of earlier ICH within 12 months preceding index event
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 coronary stent).
Trial design
Treatments tested in this trial
- Apixaban
- Aspirin
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov