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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - CHA2DS2-VASc score ≥ 2 - 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 MI). - 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 therapeutic 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Drug: Apixaban
    Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
    Other names:
    • Eliquis
Placebo Comparator
Aspirin 		Aspirin dose will be 81 mg tablet once daily.
  • Drug: Aspirin
    Aspirin is an oral antiplatelet drug.

Recruiting Locations

University of Alabama Hospital
Birmingham, Alabama 35294
Contact:
Angela Shapshak, MD

University of South Alabama University Hospital
Mobile, Alabama 36604
Contact:
Rebecca Sugg

Chandler Regional Medical Center
Chandler, Arizona 85224
Contact:
David Salvatore

Banner University Medical Center
Tucson, Arizona 85719
Contact:
Chelsea Kidwell, MD

UAMS Medical Center
Little Rock, Arkansas 77205
Contact:
Krishna Nalleballe, MD

Mercy San Juan Medical Center
Carmichael, California 95608
Contact:
Lucian Maidan

Eden Medical Center, Castro Valley
Castro Valley, California 94546
Contact:
Peter Adamczyk, MD

Arrowhead Regional Medical Center
Colton, California 92324
Contact:
Dan Miulli, MD

Rancho Los Amigos National Rehabilitation Center
Downey, California 90242
Contact:
Amy Towfighi, MD

Kaiser Permanente Fontana Medical Center
Fontana, California 92335
Contact:
Vaninder Chhabra

Long Beach Memorial Medical Center
Long Beach, California 90806
Contact:
Nima Ramezan-Arab, MD

Los Alamitos Medical Center
Los Alamitos, California 90720
Contact:
Nirav Patel, MD

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Harsimran Brara, MD

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Konrad Schlick, MD

Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
Contact:
Latisha Sharma, MD

Hoag Hospital Newport Beach
Newport Beach, California 92663
Contact:
David Brown

UC Irvine Medical Center
Orange, California 92868
Contact:
Wengui Yu, MD

Desert Regional Medical Center
Palm Springs, California 92262
Contact:
Kevin Attenhofer, MD

UC Davis Medical Center
Sacramento, California 95817
Contact:
Kwan Ng, MD

Kaiser Permanente Sacramento Medical Center
Sacramento, California 95825
Contact:
Yekaterina Axelrod, MD

San Francisco General Hospital
San Francisco, California 94110
Contact:
Claude Hemphill, MD

Stanford University Medical Center
Stanford, California 94304
Contact:
Chitra Venkat, MD

PIH Health Hospital - Whittier
Whittier, California 90602
Contact:
Gautam Ganguly, MD

St. Mary's Medical Center
Grand Junction, Colorado 81501
Contact:
Logan McDaneld, MD

Hartford Hospital
Hartford, Connecticut 06102
Contact:
Mark Alberts, MD

Yale New Haven Hospital
New Haven, Connecticut 06511
Contact:
Guido Falcone, MD

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Douglas Mayson, MD

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Yongwoo Kim, MD

Mayo Clinic
Jacksonville, Florida 32224
Contact:
Jason Siegel, MD

Jackson Memorial Hospital
Miami, Florida 33136
Contact:
Sebastian Koch

Tampa General Hospital
Tampa, Florida 33606
Contact:
Swetha Renati, MD

Grady Memorial Hospital
Atlanta, Georgia 30303
Contact:
Nirav Bhatt, MD

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Fenwick Nichols, MD

The Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Kazuma Nakagawa, MD

NCH Hospital, Arlington Heights
Arlington Heights, Illinois 60005
Contact:
Brian Walcott

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Rima Dafer, MD

University of Illinois Hospital
Chicago, Illinois 60612
Contact:
Sepideh Amin-Hanjani

University of Chicago Medical Center
Chicago, Illinois 60637
Contact:
Scott Mendelson

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Jose Biller

OSF St. Francis Medical Center
Peoria, Illinois 61637
Contact:
Arun Talkad

Javon Bea Hospital - Riverside
Rockford, Illinois 61114
Contact:
Vibhav Bansal, MD

St. John's Hospital
Springfield, Illinois 62769
Contact:
Naim Khoury, MD

Central DuPage Hospital
Winfield, Illinois 60190
Contact:
Dhruvil Pandya, MD

University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
Contact:
Amir Shaban, MD

University of Kentucky Hospital
Lexington, Kentucky 40536
Contact:
L. Creed Pettigrew

University of Louisville Hospital
Louisville, Kentucky 40202
Contact:
Wei Liu

Ochsner Medical Center - Main Campus
New Orleans, Louisiana 70121
Contact:
Richard Zweifler

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Mahmut Edip Gurol

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Steven Feske, MD

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Magdy Selim, MD

Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
Contact:
Barbara Voetsch, MD

Baystate Medical Center
Springfield, Massachusetts 01199
Contact:
Gottfried Schlaug, MD

University of Michigan University Hospital
Ann Arbor, Michigan 48109
Contact:
Aditya Pandey

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Angelos Katramados

McLaren Flint
Flint, Michigan 48532
Contact:
Bharath Naravetla, MD

Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
Contact:
Muhammad Farooq

McLaren Macomb
Mount Clemens, Michigan 48043
Contact:
Bharath Naravetla, MD

Metro Health Hospital
Wyoming, Michigan 49519
Contact:
Augusto Elias, MD

Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Mark Young, MD

University of Minnesota Medical Center Hospital
Minneapolis, Minnesota 55455
Contact:
Oladi Bentho, MD

St. Cloud Hospital
Saint Cloud, Minnesota 56303
Contact:
Suri Muhammad Fareed, MD

HealthPartners Methodist Hospital
Saint Louis Park, Minnesota 55426
Contact:
Darwin Ramirez Abreu, MD

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Darwin Ramirez-Abreu, MD

United Hospital, St. Paul
Saint Paul, Minnesota 55102
Contact:
Corry Corry, MD

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Chad Washington

Barnes Jewish Hospital
Saint Louis, Missouri 63110
Contact:
Renee Van Stavern, MD

University of Nebraska Medical Center
Omaha, Nebraska 68105
Contact:
Pierre Fayad, MD

Capital Health Regional Medical Center
Trenton, New Jersey 08638
Contact:
Hermann Christian Schumacher, MD

University of New Mexico Hospital
Albuquerque, New Mexico 87106
Contact:
Tarun Girotra, MD

Montefiore Medical Center
Bronx, New York 10467
Contact:
Kathryn Kirchoff, MD

Kings County Hospital Center
Brooklyn, New York 11203
Contact:
Susan Law, MD

NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York 11215
Contact:
Yahya Atalay, MD

Maimonides Medical Center
Brooklyn, New York 11219
Contact:
Sanskriti Mishra, MD

NYU Langone Hospital - Brooklyn
Brooklyn, New York 11220
Contact:
Jennifer Frontera

Buffalo General Medical Center
Buffalo, New York 14202
Contact:
Amit Kandel, MD

North Shore University Hospital
Manhasset, New York 11030
Contact:
Tania Rebeiz, MD

NYP Columbia University Medical Center
New York, New York 10032
Contact:
Imama Naqvi, MD

NYP Weill Cornell Medical Center
New York, New York 10065
Contact:
Hooman Kamel, MD

Strong Memorial Hospital
Rochester, New York 14642
Contact:
Curtis Benesch, MD

Staten Island University Hospital - North Campus
Staten Island, New York 10305
Contact:
Yasir El-Sherif

SUNY Upstate Medical University
Syracuse, New York 13210
Contact:
Karen Albright

University of North Carolina Medical Center
Chapel Hill, North Carolina 27514
Contact:
David Huang, MD

Carolinas Medical Center
Charlotte, North Carolina 28204
Contact:
Nikhil Patel, MD

Moses H. Cone Memorial Hospital
Greensboro, North Carolina 27401
Contact:
Pramod Sethi, MD

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
Contact:
Stacey Wolfe, MD

Akron General Medical Center
Akron, Ohio 44307
Contact:
James Gebel

University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Contact:
Daniel Woo

UH Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Abhishek Ray, MD

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Agnieszka Ardelt

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Blake Buletko

OSU Wexner Medical Center
Columbus, Ohio 43210
Contact:
Yousef Hannawi, MD

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Vivek Rai, MD

OU Medical Center
Oklahoma City, Oklahoma 73104
Contact:
Evgeny Sidorov

Oregon Health & Science University Hospital
Portland, Oregon 92739
Contact:
Wayne Clark

Providence St. Vincent Medical Center
Portland, Oregon 97213
Contact:
John Zurasky

PeaceHealth Sacred Heart Medical Center - RiverBend
Springfield, Oregon 97477
Contact:
Elaine Skalabrin, MD

Abington Memorial Hospital
Abington, Pennsylvania 19001
Contact:
Larami MacKenzie

Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania 18103

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Christopher Favilla, MD

UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
Contact:
Marcelo Rocha

Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Michael Reznik

Medical University of South Carolina University Hospital
Charleston, South Carolina 29425
Contact:
Christine Holmstedt, MD

Greenville Hospital System
Greenville, South Carolina 29605
Contact:
Sanjeev Sivakumar, MD

Methodist University Hospital
Memphis, Tennessee 38104
Contact:
Balaji Krishnaiah, MD

St. David's Medical Center
Austin, Texas 78705
Contact:
Angel Pulido, MD

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
Bappaditya Ray

Baylor College of Medicine Medical Center
Houston, Texas 77030
Contact:
Chethan Venkatasubba Rao, MD

Houston Methodist Hospital
Houston, Texas 77030
Contact:
Britz Britz, MD

Memorial Hermann Texas Medical Center
Houston, Texas 77030
Contact:
Andrew Barreto, MD

University of Texas Health Science Center San Antonio
San Antonio, Texas 78229
Contact:
Reza Behrouz, MD

University of Utah Healthcare
Salt Lake City, Utah 84112
Contact:
Safdar Ansari, MD

The University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Chris Commichau

UVA Medical Center
Charlottesville, Virginia 22908
Contact:
Brad Worral, MD

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
Steven O'Donnell, MD

Harborview Medical Center
Seattle, Washington 98104
Contact:
David Tirschwell, MD

WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia 26506
Contact:
Amelia Adcock, MD

Froedtert Hospital
Milwaukee, Wisconsin 53226
Contact:
Hatim Attar, MD

More Details

NCT ID
NCT03907046
Status
Recruiting
Sponsor
Yale University

Study Contact

Kevin N Sheth, MD
203-737-8051
kevin.sheth@yale.edu

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 high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.