Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Launched by YALE UNIVERSITY · Apr 4, 2019
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether a medication called apixaban is better than aspirin for preventing strokes and death in patients who have recently had a type of brain bleed known as intracerebral hemorrhage (ICH) and also have a heart condition called atrial fibrillation (AF). The main goal is to see if apixaban can help reduce the risk of any type of stroke or death compared to aspirin. Additionally, the study will evaluate if patients taking apixaban experience better recovery and function in daily life.
To participate in the trial, individuals must be at least 18 years old, have had a confirmed brain bleed, and have a diagnosis of non-valvular atrial fibrillation. Participants will be recruited within 14 to 180 days after their brain bleed. If you or a loved one meet these criteria and are willing to join, you can expect to be monitored closely throughout the study. It's important to note that certain health conditions, such as recent severe bleeding or active infections, may exclude someone from participating. The trial is currently recruiting, and all genders are welcome to join.
Gender
ALL
Eligibility criteria
- 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 ≥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
About Yale University
Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Brooklyn, New York, United States
San Francisco, California, United States
Springfield, Massachusetts, United States
Bronx, New York, United States
Greenville, South Carolina, United States
Abington, Pennsylvania, United States
Providence, Rhode Island, United States
Boston, Massachusetts, United States
Maywood, Illinois, United States
Detroit, Michigan, United States
Tulsa, Oklahoma, United States
Los Angeles, California, United States
Manhasset, New York, United States
Boston, Massachusetts, United States
Bangor, Maine, United States
Hackensack, New Jersey, United States
Long Beach, California, United States
Cleveland, Ohio, United States
Poughkeepsie, New York, United States
Louisville, Kentucky, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
Seattle, Washington, United States
Chicago, Illinois, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Phoenix, Arizona, United States
Peoria, Illinois, United States
Saint Cloud, Minnesota, United States
Saint Paul, Minnesota, United States
Washington, District Of Columbia, United States
Clearwater, Florida, United States
Philadelphia, Pennsylvania, United States
Springfield, Illinois, United States
Winston Salem, North Carolina, United States
Winfield, Illinois, United States
Valhalla, New York, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Ann Arbor, Michigan, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
Seattle, Washington, United States
Evanston, Illinois, United States
Omaha, Nebraska, United States
Cleveland, Ohio, United States
Hartford, Connecticut, United States
Columbus, Ohio, United States
Falls Church, Virginia, United States
Wyoming, Michigan, United States
Downey, California, United States
Washington, District Of Columbia, United States
Syracuse, New York, United States
Sacramento, California, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Augusta, Georgia, United States
Dallas, Texas, United States
Colton, California, United States
Tampa, Florida, United States
Palm Springs, California, United States
Atlanta, Georgia, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Marietta, Georgia, United States
Trenton, New Jersey, United States
Winston Salem, North Carolina, United States
Birmingham, Alabama, United States
Rochester, New York, United States
Fullerton, California, United States
Cincinnati, Ohio, United States
Hershey, Pennsylvania, United States
Brooklyn, New York, United States
Chattanooga, Tennessee, United States
Worcester, Massachusetts, United States
Tampa, Florida, United States
Oklahoma City, Oklahoma, United States
Los Angeles, California, United States
Grand Rapids, Michigan, United States
Springfield, Missouri, United States
Akron, Ohio, United States
Abington, Pennsylvania, United States
Kansas City, Kansas, United States
Danbury, Connecticut, United States
Pasadena, California, United States
Greensboro, North Carolina, United States
Richmond, Virginia, United States
Orange, California, United States
Milwaukee, Wisconsin, United States
Lexington, Kentucky, United States
Stony Brook, New York, United States
Atlanta, Georgia, United States
Memphis, Tennessee, United States
Pittsburgh, Pennsylvania, United States
Durham, North Carolina, United States
Saint Louis, Missouri, United States
New York, New York, United States
Los Angeles, California, United States
Lexington, Kentucky, United States
Houston, Texas, United States
Carmichael, California, United States
Iowa City, Iowa, United States
Oklahoma City, Oklahoma, United States
Charlotte, North Carolina, United States
Omaha, Nebraska, United States
Knoxville, Tennessee, United States
Columbia, Missouri, United States
Richmond, Virginia, United States
Saint Louis, Missouri, United States
Stanford, California, United States
New York, New York, United States
Burlington, Vermont, United States
Flint, Michigan, United States
Mount Clemens, Michigan, United States
Nashville, Tennessee, United States
Iowa City, Iowa, United States
Burlington, Massachusetts, United States
Charlottesville, Virginia, United States
Charleston, South Carolina, United States
Summit, New Jersey, United States
Saint Louis, Missouri, United States
Chandler, Arizona, United States
Chicago, Illinois, United States
New York, New York, United States
Columbus, Ohio, United States
Austin, Texas, United States
Sacramento, California, United States
Allentown, Pennsylvania, United States
Albuquerque, New Mexico, United States
Portland, Oregon, United States
Chapel Hill, North Carolina, United States
Los Alamitos, California, United States
New York, New York, United States
New Haven, Connecticut, United States
Grand Junction, Colorado, United States
Jacksonville, Florida, United States
Sioux Falls, South Dakota, United States
Cleveland, Ohio, United States
Fontana, California, United States
Brooklyn, New York, United States
Morgantown, West Virginia, United States
Springfield, Missouri, United States
Newport Beach, California, United States
Mobile, Alabama, United States
Brooklyn, New York, United States
Seattle, Washington, United States
Houston, Texas, United States
Minneapolis, Minnesota, United States
New Orleans, Louisiana, United States
Tucson, Arizona, United States
Washington, District Of Columbia, United States
Little Rock, Arkansas, United States
Castro Valley, California, United States
Modesto, California, United States
Redwood City, California, United States
Whittier, California, United States
Arlington Heights, Illinois, United States
Rockford, Illinois, United States
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
Buffalo, New York, United States
Staten Island, New York, United States
Portland, Oregon, United States
Springfield, Oregon, United States
Salt Lake City, Utah, United States
Minneapolis, Minnesota, United States
Charlotte, North Carolina, United States
Tulsa, Oklahoma, United States
Grand Rapids, Michigan, United States
Greenville, North Carolina, United States
Pensacola, Florida, United States
Port Saint Lucie, Florida, United States
Wilmington, Delaware, United States
Elmhurst, New York, United States
Boise, Idaho, United States
Memphis, Tennessee, United States
Patients applied
Trial Officials
Kevin N Sheth, MD
Principal Investigator
Yale University
Hooman Kamel, MD
Principal Investigator
Weill Medical College of Cornell University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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