Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Who is this study for? Patients with recent intracerebral hemorrhage and atrial fibrillation
Status: Recruiting
Location: See all (184) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama Hospital
RECRUITING
Birmingham
University of South Alabama University Hospital
RECRUITING
Mobile
Arkansas
UAMS Medical Center
WITHDRAWN
Little Rock
Arizona
Chandler Regional Medical Center
WITHDRAWN
Chandler
St. Joseph's Hospital and Medical Center
WITHDRAWN
Phoenix
Banner University Medical Center
RECRUITING
Tucson
California
Mercy San Juan Medical Center
RECRUITING
Carmichael
Eden Medical Center, Castro Valley
WITHDRAWN
Castro Valley
Arrowhead Regional Medical Center
RECRUITING
Colton
Rancho Los Amigos National Rehabilitation Center
SUSPENDED
Downey
Kaiser Permanente Fontana Medical Center
RECRUITING
Fontana
Community Regional Medical Center of Fresno
RECRUITING
Fresno
St. Jude Medical Center
RECRUITING
Fullerton
Long Beach Memorial Medical Center
WITHDRAWN
Long Beach
Los Alamitos Medical Center
RECRUITING
Los Alamitos
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
Doctors Medical Center Modesto, Modesto, CA
RECRUITING
Modesto
Hoag Hospital Newport Beach
WITHDRAWN
Newport Beach
UC Irvine Medical Center
RECRUITING
Orange
Desert Regional Medical Center
RECRUITING
Palm Springs
Huntington Memorial Hospital
WITHDRAWN
Pasadena
Kaiser Permanente Redwood City Medical Center, Redwood City, CA
RECRUITING
Redwood City
Kaiser Permanente Sacramento Medical Center
RECRUITING
Sacramento
UC Davis Medical Center
RECRUITING
Sacramento
San Francisco General Hospital
RECRUITING
San Francisco
Santa Barbara Cottage Hospital
RECRUITING
Santa Barbara
Stanford University Medical Center
RECRUITING
Stanford
PIH Health Hospital - Whittier
RECRUITING
Whittier
Colorado
University of Colorado Hospital
RECRUITING
Aurora
St. Mary's Medical Center
WITHDRAWN
Grand Junction
Connecticut
Danbury Hospital
SUSPENDED
Danbury
Hartford Hospital
RECRUITING
Hartford
Yale New Haven Hospital
RECRUITING
New Haven
Washington, D.c.
George Washington University Hospital
RECRUITING
Washington D.c.
MedStar Georgetown University Hospital
RECRUITING
Washington D.c.
MedStar Washington Hospital Center
WITHDRAWN
Washington D.c.
Delaware
New Hanover Regional Medical Center
RECRUITING
Wilmington
Florida
Morton Plant Hospital
RECRUITING
Clearwater
Broward Health Medical Center
RECRUITING
Fort Lauderdale
Mayo Clinic
TERMINATED
Jacksonville
UF Health Jacksonville
RECRUITING
Jacksonville
Jackson Memorial Hospital
RECRUITING
Miami
Ascension Sacred Heart Pensacola
RECRUITING
Pensacola
Cleveland Clinic Tradition Hospital
RECRUITING
Port Saint Lucie
St. Joseph's Hospital
RECRUITING
Tampa
Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory University Hospital
RECRUITING
Atlanta
Grady Memorial Hospital
RECRUITING
Atlanta
Augusta University Medical Center
RECRUITING
Augusta
WellStar Kennestone Hospital
RECRUITING
Marietta
Hawaii
The Queen's Medical Center
RECRUITING
Honolulu
Iowa
University of Iowa Medical Center
RECRUITING
Iowa City
Idaho
Saint Alphonsus Regional Medical Center - Boise
RECRUITING
Boise
Illinois
NCH Hospital, Arlington Heights
RECRUITING
Arlington Heights
Rush University Medical Center
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
University of Illinois Hospital
RECRUITING
Chicago
Evanston Hospital
RECRUITING
Evanston
Loyola University Medical Center
RECRUITING
Maywood
OSF St. Francis Medical Center
RECRUITING
Peoria
Javon Bea Hospital - Riverside
WITHDRAWN
Rockford
St. John's Hospital
WITHDRAWN
Springfield
Central DuPage Hospital
RECRUITING
Winfield
Indiana
IU Health Methodist Hospital
RECRUITING
Indianapolis
Kansas
University of Kansas Hospital
RECRUITING
Kansas City
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
University of Kentucky Hospital
RECRUITING
Lexington
University of Louisville Hospital
RECRUITING
Louisville
Louisiana
Ochsner Medical Center - Main Campus
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Lahey Hospital & Medical Center
RECRUITING
Burlington
Baystate Medical Center
RECRUITING
Springfield
UMass Memorial Medical Center
RECRUITING
Worcester
Maine
Eastern Maine Medical Center
WITHDRAWN
Bangor
Maine Medical Center
RECRUITING
Portland
Michigan
University of Michigan University Hospital
WITHDRAWN
Ann Arbor
Henry Ford Hospital
WITHDRAWN
Detroit
McLaren Flint
WITHDRAWN
Flint
Trinity Health Saint Mary's
RECRUITING
Grand Rapids
Trinity Health Saint Mary's
WITHDRAWN
Grand Rapids
McLaren Macomb
TERMINATED
Mount Clemens
Munson Medical Center
RECRUITING
Traverse City
Metro Health Hospital
WITHDRAWN
Wyoming
Minnesota
Abbott Northwestern Hospital
RECRUITING
Minneapolis
M Health Fairview University of Minnesota Medical Center
RECRUITING
Minneapolis
St. Cloud Hospital
RECRUITING
Saint Cloud
HealthPartners Methodist Hospital
ACTIVE_NOT_RECRUITING
Saint Louis Park
Regions Hospital
TERMINATED
Saint Paul
United Hospital, St. Paul
WITHDRAWN
Saint Paul
Missouri
University of Missouri Health Care
RECRUITING
Columbia
Cox Medical Center South
RECRUITING
Springfield
Mercy Hospital Springfield
RECRUITING
Springfield
Barnes Jewish Hospital
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
Mercy Hospital St. Louis
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
WITHDRAWN
Jackson
North Carolina
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Carolinas Medical Center
WITHDRAWN
Charlotte
Presbyterian Medical Center
RECRUITING
Charlotte
Duke University Hospital
RECRUITING
Durham
Moses H. Cone Memorial Hospital
RECRUITING
Greensboro
ECU Health Medical Center
RECRUITING
Greenville
New Hanover Regional Medical Center
RECRUITING
Wilmington
Forsyth Medical Center
RECRUITING
Winston-salem
Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Cooperman Barnabas Medical Center
RECRUITING
Livingston
Overlook Medical Center
RECRUITING
Summit
Capital Health Regional Medical Center
WITHDRAWN
Trenton
New Mexico
University of New Mexico Hospital
RECRUITING
Albuquerque
New York
Kings County Hospital Center
RECRUITING
Brooklyn
Maimonides Medical Center
TERMINATED
Brooklyn
NewYork-Presbyterian Brooklyn Methodist Hospital
WITHDRAWN
Brooklyn
NYU Langone Hospital - Brooklyn
RECRUITING
Brooklyn
Buffalo General Medical Center
ACTIVE_NOT_RECRUITING
Buffalo
NYC Health + Hospitals/Elmhurst
RECRUITING
Elmhurst
North Shore University Hospital
RECRUITING
Manhasset
Mount Sinai West
RECRUITING
New York
NYP Columbia University Medical Center
RECRUITING
New York
NYP Weill Cornell Medical Center
RECRUITING
New York
The Mount Sinai Hospital
RECRUITING
New York
Vassar Brothers Medical Center
TERMINATED
Poughkeepsie
Strong Memorial Hospital
RECRUITING
Rochester
Staten Island University Hospital - North Campus
WITHDRAWN
Staten Island
Stony Brook University Hospital
RECRUITING
Stony Brook
SUNY Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center
RECRUITING
The Bronx
Westchester Medical Center
RECRUITING
Valhalla
Burke Rehabilitation Center
RECRUITING
White Plains
Ohio
Cleveland Clinic Akron General
RECRUITING
Akron
Good Samaritan Hospital
RECRUITING
Cincinnati
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
MetroHealth Medical Center
RECRUITING
Cleveland
UH Cleveland Medical Center
RECRUITING
Cleveland
OSU Wexner Medical Center
RECRUITING
Columbus
Riverside Methodist Hospital
RECRUITING
Columbus
Oklahoma
Mercy Hospital Oklahoma City
RECRUITING
Oklahoma City
OU Medical Center
RECRUITING
Oklahoma City
Ascension St. John Medical Center
RECRUITING
Tulsa
St. John Medical Center
RECRUITING
Tulsa
Oregon
Oregon Health & Science University Hospital
RECRUITING
Portland
Providence St. Vincent Medical Center
RECRUITING
Portland
PeaceHealth Sacred Heart Medical Center - RiverBend
RECRUITING
Springfield
Pennsylvania
Jefferson Abington Hospital
RECRUITING
Abington
Lehigh Valley Hospital - Cedar Crest
WITHDRAWN
Allentown
Geisinger Medical Center
WITHDRAWN
Danville
Penn State Hershey Medical Center
RECRUITING
Hershey
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Temple University Hospital
RECRUITING
Philadelphia
Thomas Jefferson University Hospital
WITHDRAWN
Philadelphia
UPMC Presbyterian Hospital
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
TERMINATED
Providence
South Carolina
Medical University of South Carolina University Hospital
RECRUITING
Charleston
Greenville Hospital System
RECRUITING
Greenville
South Dakota
Avera Research Institute
RECRUITING
Sioux Falls
Tennessee
Erlanger Health System
WITHDRAWN
Chattanooga
Fort Sanders Regional Medical Center
RECRUITING
Knoxville
Methodist University Hospital
RECRUITING
Memphis
Semmes Murphey Main Campus
RECRUITING
Memphis
Vanderbilt University Hospital
RECRUITING
Nashville
Texas
St. David's Medical Center
WITHDRAWN
Austin
UT Southwestern Medical Center
WITHDRAWN
Dallas
Baylor College of Medicine Medical Center
WITHDRAWN
Houston
Houston Methodist Hospital
RECRUITING
Houston
Memorial Hermann Texas Medical Center
RECRUITING
Houston
University of Texas Health Science Center San Antonio
RECRUITING
San Antonio
Utah
University of Utah Healthcare
RECRUITING
Salt Lake City
Virginia
UVA Medical Center
RECRUITING
Charlottesville
Inova Fairfax Hospital
RECRUITING
Falls Church
Bon Secours St. Mary's Hospital
RECRUITING
Richmond
VCU Medical Center
RECRUITING
Richmond
Vermont
The University of Vermont Medical Center
RECRUITING
Burlington
Washington
Harborview Medical Center
RECRUITING
Seattle
Swedish Medical Center - Cherry Hill Campus
WITHDRAWN
Seattle
Virginia Mason Medical Center
WITHDRAWN
Seattle
Wisconsin
Froedtert Hospital
WITHDRAWN
Milwaukee
West Virginia
WVU Healthcare Ruby Memorial Hospital
RECRUITING
Morgantown
Contact Information
Primary
Kevin N Sheth, MD
kevin.sheth@yale.edu
443-615-4729
Backup
Hooman Kamel, MD
hok9010@med.cornell.edu
646-962-8284
Time Frame
Start Date: 2020-01-28
Estimated Completion Date: 2027-04
Participants
Target number of participants: 700
Treatments
Active_comparator: 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).
Placebo_comparator: Aspirin
Aspirin dose will be 81 mg tablet once daily.
Authors
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)