Atrial Fibrillation Clinical Trial
— ASPIREOfficial title:
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | April 2027 |
Est. primary completion date | April 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Jefferson Abington Hospital | Abington | Pennsylvania |
United States | Cleveland Clinic Akron General | Akron | Ohio |
United States | University of New Mexico Hospital | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania |
United States | University of Michigan University Hospital | Ann Arbor | Michigan |
United States | NCH Hospital, Arlington Heights | Arlington Heights | Illinois |
United States | Emory University Hospital | Atlanta | Georgia |
United States | Grady Memorial Hospital | Atlanta | Georgia |
United States | Augusta University Medical Center | Augusta | Georgia |
United States | St. David's Medical Center | Austin | Texas |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | University of Alabama Hospital | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Kings County Hospital Center | Brooklyn | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York |
United States | NYU Langone Hospital - Brooklyn | Brooklyn | New York |
United States | Buffalo General Medical Center | Buffalo | New York |
United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
United States | The University of Vermont Medical Center | Burlington | Vermont |
United States | Mercy San Juan Medical Center | Carmichael | California |
United States | Eden Medical Center, Castro Valley | Castro Valley | California |
United States | Chandler Regional Medical Center | Chandler | Arizona |
United States | University of North Carolina Medical Center | Chapel Hill | North Carolina |
United States | Medical University of South Carolina University Hospital | Charleston | South Carolina |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | UVA Medical Center | Charlottesville | Virginia |
United States | Erlanger Health System | Chattanooga | Tennessee |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | University of Illinois Hospital | Chicago | Illinois |
United States | Good Samaritan Hospital | Cincinnati | Ohio |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Morton Plant Hospital | Clearwater | Florida |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | UH Cleveland Medical Center | Cleveland | Ohio |
United States | Arrowhead Regional Medical Center | Colton | California |
United States | OSU Wexner Medical Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Danbury Hospital | Danbury | Connecticut |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Rancho Los Amigos National Rehabilitation Center | Downey | California |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | McLaren Flint | Flint | Michigan |
United States | Kaiser Permanente Fontana Medical Center | Fontana | California |
United States | St. Mary's Medical Center | Grand Junction | Colorado |
United States | Trinity Health Saint Mary's | Grand Rapids | Michigan |
United States | Trinity Health Saint Mary's | Grand Rapids | Michigan |
United States | Moses H. Cone Memorial Hospital | Greensboro | North Carolina |
United States | Greenville Hospital System | Greenville | South Carolina |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
United States | The Queen's Medical Center | Honolulu | Hawaii |
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 Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | Fort Sanders Regional Medical Center | Knoxville | Tennessee |
United States | University of Kentucky Hospital | Lexington | Kentucky |
United States | UAMS Medical Center | Little Rock | Arkansas |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | Los Alamitos Medical Center | Los Alamitos | California |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
United States | University of Louisville Hospital | Louisville | Kentucky |
United States | North Shore University Hospital | Manhasset | New York |
United States | WellStar Kennestone Hospital | Marietta | Georgia |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Methodist University Hospital | Memphis | Tennessee |
United States | Jackson Memorial Hospital | Miami | Florida |
United States | Froedtert Hospital | Milwaukee | Wisconsin |
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota |
United States | University of South Alabama University Hospital | Mobile | Alabama |
United States | Doctors Medical Center Modesto, Modesto, CA | Modesto | California |
United States | WVU Healthcare Ruby Memorial Hospital | Morgantown | West Virginia |
United States | McLaren Macomb | Mount Clemens | Michigan |
United States | Vanderbilt University Hospital | Nashville | Tennessee |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | Ochsner Medical Center - Main Campus | New Orleans | Louisiana |
United States | Mount Sinai West | 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 | The Mount Sinai Hospital | New York | New York |
United States | Hoag Hospital Newport Beach | Newport Beach | California |
United States | OU Medical Center | Oklahoma City | Oklahoma |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
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 | Ascension Sacred Heart Pensacola | Pensacola | Florida |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania |
United States | Cleveland Clinic Tradition Hospital | Port Saint Lucie | Florida |
United States | Oregon Health & Science University Hospital | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Kaiser Permanente Redwood City Medical Center, Redwood City, CA | Redwood City | California |
United States | VCU Medical Center | Richmond | Virginia |
United States | Strong Memorial Hospital | Rochester | New York |
United States | Javon Bea Hospital - Riverside | Rockford | Illinois |
United States | Kaiser Permanente Sacramento Medical Center | Sacramento | California |
United States | UC Davis Medical Center | Sacramento | California |
United States | St. Cloud Hospital | Saint Cloud | Minnesota |
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
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 Utah Healthcare | Salt Lake City | Utah |
United States | University of Texas Health Science Center San Antonio | San Antonio | Texas |
United States | San Francisco General Hospital | San Francisco | California |
United States | Harborview Medical Center | Seattle | Washington |
United States | Swedish Medical Center - Cherry Hill Campus | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Avera Research Institute | Sioux Falls | South Dakota |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Cox Medical Center South | Springfield | Missouri |
United States | PeaceHealth Sacred Heart Medical Center - RiverBend | Springfield | Oregon |
United States | St. John's Hospital | Springfield | Illinois |
United States | Stanford University Medical Center | Stanford | California |
United States | Staten Island University Hospital - North Campus | Staten Island | New York |
United States | Stony Brook University Hospital | Stony Brook | New York |
United States | Overlook Medical Center | Summit | New Jersey |
United States | SUNY Upstate Medical University | Syracuse | New York |
United States | St. Joseph's Hospital | Tampa | Florida |
United States | Tampa General Hospital | Tampa | Florida |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Capital Health Regional Medical Center | Trenton | New Jersey |
United States | Banner University Medical Center | Tucson | Arizona |
United States | Ascension St. John Medical Center | Tulsa | Oklahoma |
United States | St. John Medical Center | Tulsa | Oklahoma |
United States | Westchester Medical Center | Valhalla | New York |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | PIH Health Hospital - Whittier | Whittier | California |
United States | New Hanover Regional Medical Center | Wilmington | Delaware |
United States | Central DuPage Hospital | Winfield | Illinois |
United States | Forsyth Medical Center | Winston-Salem | North Carolina |
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
United States | UMass Memorial Medical Center | Worcester | Massachusetts |
United States | Metro Health Hospital | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stroke or death | Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause | Up to 3 years | |
Secondary | Modified Rankin Scale (mRS) score | Measure of neurologic disability (0=no disability to 6=dead) | Change from baseline to 12 months; change over duration of follow-up |
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