Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
- Conditions
- Atrial FibrillationIntracerebral Hemorrhage
- Interventions
- Registration Number
- NCT03907046
- Lead Sponsor
- Yale University
- 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.
- Detailed Description
ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and non-valvular AF. Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apixaban 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). Aspirin Aspirin Aspirin dose will be 81 mg tablet once daily.
- Primary Outcome Measures
Name Time Method Stroke or death Up to 3 years Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause
- Secondary Outcome Measures
Name Time Method Modified Rankin Scale (mRS) score Change from baseline to 12 months; change over duration of follow-up Measure of neurologic disability (0=no disability to 6=dead)
Trial Locations
- Locations (169)
University of South Alabama University Hospital
🇺🇸Mobile, Alabama, United States
Chandler Regional Medical Center
🇺🇸Chandler, Arizona, 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, District of Columbia, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸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 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
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
OSU Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Ascension St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
St. John Medical Center
🇺🇸Tulsa, Oklahoma, 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
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Cox Medical Center South
🇺🇸Springfield, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Hackensack University Medical Center
🇺🇸Hackensack, 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
University of Alabama Hospital
🇺🇸Birmingham, Alabama, 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
Stanford University Medical Center
🇺🇸Stanford, California, United States
PIH Health Hospital - Whittier
🇺🇸Whittier, California, 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
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
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
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
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
Montefiore Medical Center
🇺🇸Bronx, New York, 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
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
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Moses H. Cone Memorial Hospital
🇺🇸Greensboro, 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
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
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