Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Description

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.

Conditions

Intracerebral Hemorrhage, Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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.

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Condition
Intracerebral Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Hospital, Birmingham, Alabama, United States, 35294

Mobile

University of South Alabama University Hospital, Mobile, Alabama, United States, 36604

Chandler

Chandler Regional Medical Center, Chandler, Arizona, United States, 85224

Phoenix

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, 85013

Tucson

Banner University Medical Center, Tucson, Arizona, United States, 85719

Little Rock

UAMS Medical Center, Little Rock, Arkansas, United States, 77205

Carmichael

Mercy San Juan Medical Center, Carmichael, California, United States, 95608

Castro Valley

Eden Medical Center, Castro Valley, Castro Valley, California, United States, 94546

Colton

Arrowhead Regional Medical Center, Colton, California, United States, 92324

Downey

Rancho Los Amigos National Rehabilitation Center, Downey, California, United States, 90242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 ≥2.5 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 (≥180 mm Hg)
  • * ICH caused by an arteriovenous malformation (AVM) that has not yet been secured

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Kevin N Sheth, MD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Hooman Kamel, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2027-04