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NCT03907046PHASE3Recruiting

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Yale University

Start Date

1/28/2020

Completion Date

4/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Apixaban

DRUG

Aspirin

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Conditions

Intracerebral HemorrhageAtrial Fibrillation

Locations

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