Recruiting

Phase 3

AnticoagulationAnticoagulation in ICH Survivors for Stroke Prevention and Recovery

Sponsor:

Yale University

Code:

NCT03907046

Conditions

Intracerebral Hemorrhage

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apixaban

Aspirin

Study Details

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.

Conditions

Intracerebral Hemorrhage

Atrial Fibrillation

Study ID

NCT03907046

Start date

Jan 28, 2020

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Apixaban

Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.

Aspirin

Aspirin is an oral antiplatelet drug.

Primary outcome measure

Stroke or death [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Kevin N Sheth, MD

443-615-4729 kevin.sheth@yale.edu

Hooman Kamel, MD

646-962-8284 hok9010@med.cornell.edu

Locations

University of Alabama Hospital

Recruiting

Birmingham, Alabama, United States, 35294

University of South Alabama University Hospital

Recruiting

Mobile, Alabama, United States, 36604

Banner University Medical Center

Recruiting

Tucson, Arizona, United States, 85719

Mercy San Juan Medical Center

Recruiting

Carmichael, California, United States, 95608

Arrowhead Regional Medical Center

Recruiting

Colton, California, United States, 92324

Kaiser Permanente Fontana Medical Center

Recruiting

Fontana, California, United States, 92335

Community Regional Medical Center of Fresno

Recruiting

Fresno, California, United States, 93720

St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

Los Alamitos Medical Center

Recruiting

Los Alamitos, California, United States, 90720

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Doctors Medical Center Modesto, Modesto, CA

Recruiting

Modesto, California, United States, 95350

UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Desert Regional Medical Center

Recruiting

Palm Springs, California, United States, 92262

Kaiser Permanente Redwood City Medical Center, Redwood City, CA

Recruiting

Redwood City, California, United States, 94063

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Kaiser Permanente Sacramento Medical Center

Recruiting

Sacramento, California, United States, 95825

San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93105

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94304

PIH Health Hospital - Whittier

Recruiting

Whittier, California, United States, 90602

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06511

New Hanover Regional Medical Center

Recruiting

Wilmington, Delaware, United States, 28403

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

George Washington University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20037

Morton Plant Hospital

Recruiting

Clearwater, Florida, United States, 33756

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

UF Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Ascension Sacred Heart Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Cleveland Clinic Tradition Hospital

Recruiting

Port Saint Lucie, Florida, United States, 34987

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

St. Joseph's Hospital

Recruiting

Tampa, Florida, United States, 33607

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

WellStar Kennestone Hospital

Recruiting

Marietta, Georgia, United States, 30060

The Queen's Medical Center

Recruiting

Honolulu, Hawaii, United States, 96813

Saint Alphonsus Regional Medical Center - Boise

Recruiting

Boise, Idaho, United States, 83706

NCH Hospital, Arlington Heights

Recruiting

Arlington Heights, Illinois, United States, 60005

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

University of Illinois Hospital

Recruiting

Chicago, Illinois, United States, 60612

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

OSF St. Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Central DuPage Hospital

Recruiting

Winfield, Illinois, United States, 60190

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

University of Iowa Medical Center

Recruiting

Iowa City, Iowa, United States, 52242

University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

University of Kentucky Hospital

Recruiting

Lexington, Kentucky, United States, 40536

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Ochsner Medical Center - Main Campus

Recruiting

New Orleans, Louisiana, United States, 70121

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Trinity Health Saint Mary's

Recruiting

Grand Rapids, Michigan, United States, 49503

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

M Health Fairview University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

St. Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65212

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Cox Medical Center South

Recruiting

Springfield, Missouri, United States, 65807

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Mercy Hospital St. Louis

Recruiting

St Louis, Missouri, United States, 63141

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

JFK Medical Center

Recruiting

Edison, New Jersey, United States, 08820

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07052

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Kings County Hospital Center

Recruiting

Brooklyn, New York, United States, 11203

NYU Langone Hospital - Brooklyn

Recruiting

Brooklyn, New York, United States, 11220

NYC Health + Hospitals/Elmhurst

Recruiting

Elmhurst, New York, United States, 11373

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Mount Sinai West

Recruiting

New York, New York, United States, 10019

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

NYP Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

NYP Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Strong Memorial Hospital

Recruiting

Rochester, New York, United States, 14642

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Burke Rehabilitation Center

Recruiting

White Plains, New York, United States, 10605

University of North Carolina Medical Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Presbyterian Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Moses H. Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

ECU Health Medical Center

Recruiting

Greenville, North Carolina, United States, 27834

New Hanover Regional Medical Center

Recruiting

Wilmington, North Carolina, United States, 28403

Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Cleveland Clinic Akron General

Recruiting

Akron, Ohio, United States, 44307

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

OSU Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

OU Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Mercy Hospital Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Ascension St. John Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

St. John Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

Oregon Health & Science University Hospital

Recruiting

Portland, Oregon, United States, 92739

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97213

PeaceHealth Sacred Heart Medical Center - RiverBend

Recruiting

Springfield, Oregon, United States, 97477

Jefferson Abington Hospital

Recruiting

Abington, Pennsylvania, United States, 19001

Penn State Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical University of South Carolina University Hospital

Recruiting

Charleston, South Carolina, United States, 29425

Greenville Hospital System

Recruiting

Greenville, South Carolina, United States, 29605

Avera Research Institute

Recruiting

Sioux Falls, South Dakota, United States, 57108

Fort Sanders Regional Medical Center

Recruiting

Knoxville, Tennessee, United States, 37916

Methodist University Hospital

Recruiting

Memphis, Tennessee, United States, 38104

Semmes Murphey Main Campus

Recruiting

Memphis, Tennessee, United States, 38120

Vanderbilt University Hospital

Recruiting

Nashville, Tennessee, United States, 37232

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Memorial Hermann Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

University of Utah Healthcare

Recruiting

Salt Lake City, Utah, United States, 84112

The University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

UVA Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Bon Secours St. Mary's Hospital

Recruiting

Richmond, Virginia, United States, 23226

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

J.W. Ruby Memorial Hospital

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

Yale University

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-08.