Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
NCT ID: NCT03907046
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2020-01-28
2027-04-30
Brief Summary
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Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Apixaban
Apixaban dosing will be 5 mg tablet in morning and 5 mg tablet in evening. A reduced dose of 2.5 mg tablet in morning and 2.5 mg tablet in evening will be used if: (1) ≥2 of the following are present: age ≥80 years, body weight ≤60 kg, or serum creatinine 1.5-2.4 mg/dL, or (2) Patient is taking a strong CYP3A4/pGP inhibitor (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin).
Apixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
Aspirin
Aspirin dose will be 81 mg tablet once daily.
Aspirin
Aspirin is an oral antiplatelet drug.
Interventions
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Apixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
Aspirin
Aspirin is an oral antiplatelet drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Kevin N Sheth, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Hooman Kamel, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
University of South Alabama University Hospital
Mobile, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
UAMS Medical Center
Little Rock, Arkansas, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Eden Medical Center, Castro Valley
Castro Valley, California, United States
Arrowhead Regional Medical Center
Colton, California, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, United States
St. Jude Medical Center
Fullerton, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Los Alamitos Medical Center
Los Alamitos, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Doctors Medical Center Modesto, Modesto, CA
Modesto, California, United States
Hoag Hospital Newport Beach
Newport Beach, California, United States
UC Irvine Medical Center
Orange, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Kaiser Permanente Redwood City Medical Center, Redwood City, CA
Redwood City, California, United States
UC Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
San Francisco General Hospital
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Stanford University Medical Center
Stanford, California, United States
PIH Health Hospital - Whittier
Whittier, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
St. Mary's Medical Center
Grand Junction, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
New Hanover Regional Medical Center
Wilmington, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Ascension Sacred Heart Pensacola
Pensacola, Florida, United States
Cleveland Clinic Tradition Hospital
Port Saint Lucie, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho, United States
NCH Hospital, Arlington Heights
Arlington Heights, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Javon Bea Hospital - Riverside
Rockford, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
University of Iowa Medical Center
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Ochsner Medical Center - Main Campus
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan University Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
McLaren Flint
Flint, Michigan, United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, United States
McLaren Macomb
Mount Clemens, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
St. Cloud Hospital
Saint Cloud, Minnesota, United States
HealthPartners Methodist Hospital
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital, St. Paul
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri Health Care
Columbia, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Cox Medical Center South
Springfield, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Capital Health Regional Medical Center
Trenton, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Kings County Hospital Center
Brooklyn, New York, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
NYC Health + Hospitals/Elmhurst
Elmhurst, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai West
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
NYP Columbia University Medical Center
New York, New York, United States
NYP Weill Cornell Medical Center
New York, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Staten Island University Hospital - North Campus
Staten Island, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
ECU Health Medical Center
Greenville, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
OU Medical Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Ascension St. John Medical Center
Tulsa, Oklahoma, United States
St. John Medical Center
Tulsa, Oklahoma, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
PeaceHealth Sacred Heart Medical Center - RiverBend
Springfield, Oregon, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States
Greenville Hospital System
Greenville, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
Semmes Murphey Main Campus
Memphis, Tennessee, United States
Vanderbilt University Hospital
Nashville, Tennessee, United States
St. David's Medical Center
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
UVA Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Angela Shapshak, MD
Role: primary
Taha Nisar, MD
Role: primary
Supreet Kaur, MD
Role: primary
Firas Kaddouh, MD
Role: primary
Lucian Maidan
Role: primary
Dan Miulli, MD
Role: primary
Vaninder Chhabra
Role: primary
Harry Peled, MD
Role: primary
Nirav Patel, MD
Role: primary
Harsimran Brara, MD
Role: primary
Konrad Schlick, MD
Role: primary
Latisha Sharma, MD
Role: primary
James Jaffe, MD
Role: primary
Wengui Yu, MD
Role: primary
Kevin Attenhofer, MD
Role: primary
Sheila Chan, MD
Role: primary
Kwan Ng, MD
Role: primary
Yekaterina Axelrod, MD
Role: primary
Claude Hemphill, MD
Role: primary
Brian Walcott, MD
Role: primary
Chitra Venkat, MD
Role: primary
Gautam Ganguly, MD
Role: primary
Sharon Poisson, MD
Role: primary
Mark Alberts, MD
Role: primary
Guido Falcone, MD
Role: primary
James McKinney, MD
Role: primary
Douglas Mayson, MD
Role: primary
Fernando Mayor Basto, MD
Role: primary
Ajay Arora, MD
Role: primary
Kimberly McPhearson, MD
Role: primary
Sebastian Koch
Role: primary
Terry Neill, MD
Role: primary
Marc Babi, MD
Role: primary
Swetha Renati, MD
Role: primary
Abilash Haridas, MD
Role: primary
Daniel Schachter, MD
Role: primary
Fadi Nahab, MD
Role: primary
Fenwick Nichols, MD
Role: primary
Christopher Horn, MD
Role: primary
Kazuma Nakagawa, MD
Role: primary
Lukas Clark, MD
Role: primary
Mohammad Anadani, MD
Role: primary
Rima Dafer, MD
Role: primary
Ali Alaraj, MD
Role: primary
Elisheva Coleman, MD
Role: primary
Rachel Mehendale, MD
Role: primary
Mohammad Anadani, MD
Role: primary
Sarkis Morales-Vidal, MD
Role: primary
Arun Talkad
Role: primary
Dhruvil Pandya, MD
Role: primary
Lisa Nobel, MD
Role: primary
Amir Shaban, MD
Role: primary
Kyle Carpenter, MD
Role: primary
Murali Kolikonda, MD
Role: primary
Suhas Gangadhara, MD
Role: primary
Isaac Abecassis, MD
Role: primary
Richard Zweifler
Role: primary
Teresa May, MD
Role: primary
Emiliya Melkumova, MD
Role: primary
Mariel Kozberg, MD
Role: primary
Steven Feske, MD
Role: primary
Magdy Selim, MD
Role: primary
Colin James Culbertson, MD
Role: primary
Gottfried Schlaug, MD
Role: primary
Majaz Moonis, MD
Role: primary
Muhammad Farooq, MD
Role: primary
Bharath Naravetla, MD
Role: primary
Ramiro Castro-Apolo, MD
Role: primary
Ganesh Asaithambi, MD
Role: primary
Oladi Bentho, MD
Role: primary
Muhammad Fareed Suri, MD
Role: primary
Darwin Ramirez-Abreu, MD
Role: primary
Farhan Siddiq, MD
Role: primary
Brenton Coger, MD
Role: primary
Benjamin Lisle, MD
Role: primary
Yan Wang, MD
Role: primary
Venkat Chintapally-Rao, MD
Role: primary
William Logan, MD
Role: primary
Pierre Fayad, MD
Role: primary
Kaitlin Reilly-Kit, MD
Role: primary
Steven Shapiro, MD
Role: primary
John Hanna, MD
Role: primary
Tarun Girotra, MD
Role: primary
Susan Law, MD
Role: primary
Jennifer Frontera
Role: primary
Hazem Shoirah, MD
Role: primary
Rohan Arora, MD
Role: primary
Neha Dangayach, MD
Role: primary
Neha Dangayach, MD
Role: primary
Imama Naqvi, MD
Role: primary
Hooman Kamel, MD
Role: primary
Paul Wright, MD
Role: primary
Curtis Benesch, MD
Role: primary
Jason Mathew, MD
Role: primary
Julius-Gene Latorre, MD
Role: primary
Kathryn Kirchoff-Torres, MD
Role: primary
Stephan Mayer, MD
Role: primary
Julia Carlson, MD
Role: primary
Melanie Greenway, MD
Role: primary
Dylan Ryan, MD
Role: primary
Pramod Sethi, MD
Role: primary
Shailesh Male, MD
Role: primary
Mitchell Hargis, MD
Role: primary
Stacey Wolfe, MD
Role: primary
Ahmed Itrat, MD
Role: primary
Rob Stanton, MD
Role: primary
Chengyuan Feng, MD
Role: primary
Abhishek Ray, MD
Role: primary
Agnieszka Ardelt, MD
Role: primary
Blake Buletko
Role: primary
Yousef Hannawi, MD
Role: primary
Vivek Rai, MD
Role: primary
Evgeny Sidorov
Role: primary
Jeffrey Craig, MD
Role: primary
Rahul Rahangdale, MD
Role: primary
Rahul Rahangdale, MD
Role: primary
Wayne Clark
Role: primary
John Zurasky
Role: primary
Mariam Tsikvadze, MD
Role: primary
Larami MacKenzie, MD
Role: primary
Nandakumar Nagaraja, MD
Role: primary
Aaron Rothstein, MD
Role: primary
Paul Katz, MD
Role: primary
Marcelo Rocha
Role: primary
Christine Holmstedt, MD
Role: primary
Sanjeev Sivakumar, MD
Role: primary
Jonathon Cooke, MD
Role: primary
S. Arthur Moore, MD
Role: primary
Balaji Krishnaiah, MD
Role: primary
Neha Kumar, MD
Role: primary
Deborah Kerrigan, MD
Role: primary
Britz Britz, MD
Role: primary
Andrew Barreto, MD
Role: primary
Reza Behrouz, MD
Role: primary
Nabeel Chauhan, MD
Role: primary
Chris Commichau
Role: primary
Brad Worral, MD
Role: primary
Saqib Chaudhry, MD
Role: primary
Amandeep Sangha, MD
Role: primary
Shraddha Mainali, MD
Role: primary
David Tirschwell, MD
Role: primary
Amelia Adcock, MD
Role: primary
Hatim Attar, MD
Role: primary
References
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Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
Other Identifiers
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2000026409
Identifier Type: -
Identifier Source: org_study_id
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