Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
ASPIRE
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
2 other identifiers
interventional
700
1 country
187
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2020
Longer than P75 for phase_3
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedStudy Start
First participant enrolled
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
May 8, 2026
May 1, 2026
7.2 years
April 4, 2019
May 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Stroke or death
Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause
Up to 3 years
Secondary Outcomes (1)
Modified Rankin Scale (mRS) score
Change from baseline to 12 months; change over duration of follow-up
Study Arms (2)
Apixaban
ACTIVE COMPARATORApixaban 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).
Aspirin
PLACEBO COMPARATORAspirin dose will be 81 mg tablet once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (187)
University of Alabama Hospital
Birmingham, Alabama, 35294, United States
University of South Alabama University Hospital
Mobile, Alabama, 36604, United States
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Banner University Medical Center
Tucson, Arizona, 85719, United States
UAMS Medical Center
Little Rock, Arkansas, 77205, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Eden Medical Center, Castro Valley
Castro Valley, California, 94546, United States
Arrowhead Regional Medical Center
Colton, California, 92324, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335, United States
Community Regional Medical Center of Fresno
Fresno, California, 93720, United States
St. Jude Medical Center
Fullerton, California, 92835, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Los Alamitos Medical Center
Los Alamitos, California, 90720, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Doctors Medical Center Modesto, Modesto, CA
Modesto, California, 95350, United States
Hoag Hospital Newport Beach
Newport Beach, California, 92663, United States
UC Irvine Medical Center
Orange, California, 92868, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Kaiser Permanente Redwood City Medical Center, Redwood City, CA
Redwood City, California, 94063, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Stanford University Medical Center
Stanford, California, 94304, United States
PIH Health Hospital - Whittier
Whittier, California, 90602, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
St. Mary's Medical Center
Grand Junction, Colorado, 81501, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale New Haven Hospital
New Haven, Connecticut, 06511, United States
New Hanover Regional Medical Center
Wilmington, Delaware, 28403, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Ascension Sacred Heart Pensacola
Pensacola, Florida, 32504, United States
Cleveland Clinic Tradition Hospital
Port Saint Lucie, Florida, 34987, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
St. Joseph's Hospital
Tampa, Florida, 33607, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho, 83706, United States
NCH Hospital, Arlington Heights
Arlington Heights, Illinois, 60005, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Hospital
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Evanston Hospital
Evanston, Illinois, 60201, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Javon Bea Hospital - Riverside
Rockford, Illinois, 61114, United States
St. John's Hospital
Springfield, Illinois, 62769, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
University of Iowa Medical Center
Iowa City, Iowa, 52242, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Ochsner Medical Center - Main Campus
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Medical Center
Portland, Maine, 04102, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan University Hospital
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Flint
Flint, Michigan, 48532, United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
HealthPartners Methodist Hospital
Saint Louis Park, Minnesota, 55426, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital, St. Paul
Saint Paul, Minnesota, 55102, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Cox Medical Center South
Springfield, Missouri, 65807, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
JFK Medical Center
Edison, New Jersey, 08820, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07052, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Capital Health Regional Medical Center
Trenton, New Jersey, 08638, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
Albany Medical Center
Albany, New York, 12208, United States
Kings County Hospital Center
Brooklyn, New York, 11203, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220, United States
Buffalo General Medical Center
Buffalo, New York, 14202, United States
NYC Health + Hospitals/Elmhurst
Elmhurst, New York, 11373, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Mount Sinai West
New York, New York, 10019, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
NYP Columbia University Medical Center
New York, New York, 10032, United States
NYP Weill Cornell Medical Center
New York, New York, 10065, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Staten Island University Hospital - North Campus
Staten Island, New York, 10305, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Burke Rehabilitation Center
White Plains, New York, 10605, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
ECU Health Medical Center
Greenville, North Carolina, 27834, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28403, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Ascension St. John Medical Center
Tulsa, Oklahoma, 74104, United States
St. John Medical Center
Tulsa, Oklahoma, 74104, United States
Oregon Health & Science University Hospital
Portland, Oregon, 92739, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97213, United States
PeaceHealth Sacred Heart Medical Center - RiverBend
Springfield, Oregon, 97477, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Semmes Murphey Main Campus
Memphis, Tennessee, 38120, United States
Vanderbilt University Hospital
Nashville, Tennessee, 37232, United States
St. David's Medical Center
Austin, Texas, 78705, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229, United States
University of Utah Healthcare
Salt Lake City, Utah, 84112, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
UVA Medical Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, 98122, United States
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 36700520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin N Sheth, MD
Yale University
- PRINCIPAL INVESTIGATOR
Hooman Kamel, MD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 8, 2019
Study Start
January 28, 2020
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
May 8, 2026
Record last verified: 2026-05