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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

RecruitingPhase 3

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Yale University · Participants: 700 · Started: Jan 28, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT03907046

Locations in the U.S.

AlabamaUniversity of Alabama Hospital, Birmingham
University of South Alabama University Hospital, Mobile
ArizonaBanner University Medical Center, Tucson
CaliforniaMercy San Juan Medical Center, Carmichael
Arrowhead Regional Medical Center, Colton
Kaiser Permanente Fontana Medical Center, Fontana
Community Regional Medical Center of Fresno, Fresno
St. Jude Medical Center, Fullerton
Los Alamitos Medical Center, Los Alamitos
Cedars-Sinai Medical Center, Los Angeles
Kaiser Permanente Los Angeles Medical Center, Los Angeles
Ronald Reagan UCLA Medical Center, Los Angeles
Doctors Medical Center Modesto, Modesto, CA, Modesto
UC Irvine Medical Center, Orange
Desert Regional Medical Center, Palm Springs
Kaiser Permanente Redwood City Medical Center, Redwood City, CA, Redwood City
Kaiser Permanente Sacramento Medical Center, Sacramento
UC Davis Medical Center, Sacramento
San Francisco General Hospital, San Francisco
Santa Barbara Cottage Hospital, Santa Barbara
Stanford University Medical Center, Stanford
PIH Health Hospital - Whittier, Whittier
ColoradoUniversity of Colorado Hospital, Aurora
ConnecticutHartford Hospital, Hartford
Yale New Haven Hospital, New Haven
DelawareNew Hanover Regional Medical Center, Wilmington
District of ColumbiaGeorge Washington University Hospital, Washington D.C.
MedStar Georgetown University Hospital, Washington D.C.
FloridaMorton Plant Hospital, Clearwater
Broward Health Medical Center, Fort Lauderdale
UF Health Jacksonville, Jacksonville
Jackson Memorial Hospital, Miami
Ascension Sacred Heart Pensacola, Pensacola
Cleveland Clinic Tradition Hospital, Port Saint Lucie
St. Joseph's Hospital, Tampa
Tampa General Hospital, Tampa
GeorgiaEmory University Hospital, Atlanta
Grady Memorial Hospital, Atlanta
Augusta University Medical Center, Augusta
WellStar Kennestone Hospital, Marietta
HawaiiThe Queen's Medical Center, Honolulu
IdahoSaint Alphonsus Regional Medical Center - Boise, Boise
IllinoisNCH Hospital, Arlington Heights, Arlington Heights
Rush University Medical Center, Chicago
University of Chicago Medical Center, Chicago
University of Illinois Hospital, Chicago
Evanston Hospital, Evanston
Loyola University Medical Center, Maywood
OSF St. Francis Medical Center, Peoria
Central DuPage Hospital, Winfield
IndianaIU Health Methodist Hospital, Indianapolis
IowaUniversity of Iowa Medical Center, Iowa City
KansasUniversity of Kansas Hospital, Kansas City
KentuckyBaptist Health Lexington, Lexington
University of Kentucky Hospital, Lexington
University of Louisville Hospital, Louisville
LouisianaOchsner Medical Center - Main Campus, New Orleans
MaineMaine Medical Center, Portland
MassachusettsBeth Israel Deaconess Medical Center, Boston
Boston Medical Center, Boston
Massachusetts General Hospital, Boston
Tufts Medical Center, Boston
Lahey Hospital & Medical Center, Burlington
Baystate Medical Center, Springfield
UMass Memorial Medical Center, Worcester
MichiganTrinity Health Saint Mary's, Grand Rapids
Munson Medical Center, Traverse City
MinnesotaAbbott Northwestern Hospital, Minneapolis
M Health Fairview University of Minnesota Medical Center, Minneapolis
St. Cloud Hospital, Saint Cloud
MissouriUniversity of Missouri Health Care, Columbia
Cox Medical Center South, Springfield
Mercy Hospital Springfield, Springfield
Barnes Jewish Hospital, St Louis
Mercy Hospital South, St Louis
Mercy Hospital St. Louis, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New JerseyJFK Medical Center, Edison
Hackensack University Medical Center, Hackensack
Cooperman Barnabas Medical Center, Livingston
Jersey Shore University Medical Center, Neptune City
Overlook Medical Center, Summit
New YorkAlbany Medical Center, Albany
Kings County Hospital Center, Brooklyn
NYU Langone Hospital - Brooklyn, Brooklyn
NYC Health + Hospitals/Elmhurst, Elmhurst
North Shore University Hospital, Manhasset
Mount Sinai West, New York
NYP Columbia University Medical Center, New York
NYP Weill Cornell Medical Center, New York
The Mount Sinai Hospital, New York
Strong Memorial Hospital, Rochester
Stony Brook University Hospital, Stony Brook
SUNY Upstate Medical University, Syracuse
Montefiore Medical Center, The Bronx
Westchester Medical Center, Valhalla
Burke Rehabilitation Center, White Plains
North CarolinaUniversity of North Carolina Medical Center, Chapel Hill
Presbyterian Medical Center, Charlotte
Duke University Hospital, Durham
Moses H. Cone Memorial Hospital, Greensboro
ECU Health Medical Center, Greenville
New Hanover Regional Medical Center, Wilmington
Forsyth Medical Center, Winston-Salem
Wake Forest Baptist Medical Center, Winston-Salem
OhioCleveland Clinic Akron General, Akron
Good Samaritan Hospital, Cincinnati
University of Cincinnati Medical Center, Cincinnati
Cleveland Clinic, Cleveland
MetroHealth Medical Center, Cleveland
UH Cleveland Medical Center, Cleveland
OSU Wexner Medical Center, Columbus
Riverside Methodist Hospital, Columbus
OklahomaMercy Hospital Oklahoma City, Oklahoma City
OU Medical Center, Oklahoma City
Ascension St. John Medical Center, Tulsa
St. John Medical Center, Tulsa
OregonOregon Health & Science University Hospital, Portland
Providence St. Vincent Medical Center, Portland
PeaceHealth Sacred Heart Medical Center - RiverBend, Springfield
PennsylvaniaJefferson Abington Hospital, Abington
Penn State Hershey Medical Center, Hershey
Hospital of the University of Pennsylvania, Philadelphia
Temple University Hospital, Philadelphia
UPMC Presbyterian Hospital, Pittsburgh
South CarolinaMedical University of South Carolina University Hospital, Charleston
Greenville Hospital System, Greenville
South DakotaAvera Research Institute, Sioux Falls
TennesseeFort Sanders Regional Medical Center, Knoxville
Methodist University Hospital, Memphis
Semmes Murphey Main Campus, Memphis
Vanderbilt University Hospital, Nashville
TexasHouston Methodist Hospital, Houston
Memorial Hermann Texas Medical Center, Houston
University of Texas Health Science Center San Antonio, San Antonio
UtahUniversity of Utah Healthcare, Salt Lake City
VermontThe University of Vermont Medical Center, Burlington
VirginiaUVA Medical Center, Charlottesville
Inova Fairfax Hospital, Falls Church
Bon Secours St. Mary's Hospital, Richmond
WashingtonHarborview Medical Center, Seattle
West VirginiaJ.W. Ruby Memorial Hospital, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.