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โ† Trials
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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

RecruitingPhase 3Ages 18 Years - anyAllYale University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 * Provision of signed and dated informed consent form by patient or legally authorized representative * For females of reproductive potential: use of highly effective contraception Exclusion Criteria: * 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). * Previous or planned left atrial appendage closure * Clinically significant bleeding diathesis * Serum creatinine โ‰ฅ2.5 mg/dL * Active hepatitis or hepatic insufficiency with Child-Pugh score B or C * Anemia (hemoglobin \<8 g/dL) or thrombocytopenia (\<100 x 10\^9/L) that is chronic in the judgment of the investigator * Pregnant or breastfeeding * Known allergy to aspirin or apixaban * Concomitant participation in a competing trial * Considered by the investigator to have a condition that precludes safe or active participation in the trial * Persistent, uncontrolled systolic blood pressure (โ‰ฅ180 mm Hg) * ICH caused by an arteriovenous malformation (AVM) that has not yet been secured
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What it tests

  • Apixaban
  • Aspirin
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Where

187 sites
University of Alabama Hospital
Birmingham, United States
University of South Alabama University Hospital
Mobile, United States
Chandler Regional Medical Center
Chandler, United States
St. Joseph's Hospital and Medical Center
Phoenix, United States
Banner University Medical Center
Tucson, United States
UAMS Medical Center
Little Rock, United States
Mercy San Juan Medical Center
Carmichael, United States
Eden Medical Center, Castro Valley
Castro Valley, United States

โ€ฆand 179 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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