Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
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
- Intracerebral Hemorrhage
- Atrial Fibrillation
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 - 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
- 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
Arm | Description | Assigned 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). |
|
Placebo Comparator Aspirin |
Aspirin dose will be 81 mg tablet once daily. |
|
Recruiting Locations
Birmingham, Alabama 35294
Angela Shapshak, MD
Mobile, Alabama 36604
Rebecca Sugg
Chandler, Arizona 85224
David Salvatore
Tucson, Arizona 85719
Chelsea Kidwell, MD
Little Rock, Arkansas 77205
Krishna Nalleballe, MD
Carmichael, California 95608
Lucian Maidan
Colton, California 92324
Dan Miulli, MD
Downey, California 90242
Amy Towfighi, MD
Fontana, California 92335
Vaninder Chhabra
Long Beach, California 90806
Nima Ramezan-Arab, MD
Los Alamitos, California 90720
Nirav Patel, MD
Los Angeles, California 90027
Harsimran Brara, MD
Los Angeles, California 90048
Konrad Schlick, MD
Los Angeles, California 90095
Latisha Sharma, MD
Modesto, California 95350
James Jaffe, MD
Newport Beach, California 92663
David Brown
Orange, California 92868
Wengui Yu, MD
Palm Springs, California 92262
Kevin Attenhofer, MD
Pasadena, California 91105
Arib Ohanian, MD
Redwood City, California 94063
Sheila Chan, MD
Sacramento, California 95817
Kwan Ng, MD
Sacramento, California 95825
Yekaterina Axelrod, MD
San Francisco, California 94110
Claude Hemphill, MD
Stanford, California 94304
Chitra Venkat, MD
Whittier, California 90602
Gautam Ganguly, MD
Grand Junction, Colorado 81501
Logan McDaneld, MD
Danbury, Connecticut 06810
Charles Guardia, MD
Hartford, Connecticut 06102
Mark Alberts, MD
New Haven, Connecticut 06511
Guido Falcone, MD
Washington, District of Columbia 20007
Douglas Mayson, MD
Washington, District of Columbia 20010
Yongwoo Kim, MD
Clearwater, Florida 33756
Ajay Arora, MD
Jacksonville, Florida 32224
Jason Siegel, MD
Miami, Florida 33136
Sebastian Koch
Tampa, Florida 33606
Swetha Renati, MD
Tampa, Florida 33607
Abilash Haridas, MD
Atlanta, Georgia 30303
Nirav Bhatt, MD
Atlanta, Georgia 30322
Fadi Nahab, MD
Augusta, Georgia 30912
Fenwick Nichols, MD
Marietta, Georgia 30060
Christopher Horn, MD
Honolulu, Hawaii 96813
Kazuma Nakagawa, MD
Arlington Heights, Illinois 60005
Brian Walcott
Chicago, Illinois 60612
Rima Dafer, MD
Chicago, Illinois 60612
Sepideh Amin-Hanjani
Chicago, Illinois 60637
Scott Mendelson
Maywood, Illinois 60153
Jose Biller
Peoria, Illinois 61637
Arun Talkad
Rockford, Illinois 61114
Vibhav Bansal, MD
Springfield, Illinois 62769
Naim Khoury, MD
Winfield, Illinois 60190
Dhruvil Pandya, MD
Iowa City, Iowa 52242
Amir Shaban, MD
Lexington, Kentucky 40536
L. Creed Pettigrew
Louisville, Kentucky 40202
Wei Liu
New Orleans, Louisiana 70121
Richard Zweifler
Boston, Massachusetts 02111
Emiliya Melkumova, MD
Boston, Massachusetts 02114
Mahmut Edip Gurol
Boston, Massachusetts 02118
Steven Feske, MD
Boston, Massachusetts 02215
Magdy Selim, MD
Burlington, Massachusetts 01805
Barbara Voetsch, MD
Springfield, Massachusetts 01199
Gottfried Schlaug, MD
Worcester, Massachusetts 01655
Majaz Moonis, MD
Ann Arbor, Michigan 48109
Aditya Pandey
Detroit, Michigan 48202
Angelos Katramados
Flint, Michigan 48532
Bharath Naravetla, MD
Grand Rapids, Michigan 49503
Muhammad Farooq
Grand Rapids, Michigan 49503
Muhammad Farooq, MD
Mount Clemens, Michigan 48043
Bharath Naravetla, MD
Wyoming, Michigan 49519
Augusto Elias, MD
Minneapolis, Minnesota 55407
Mark Young, MD
Minneapolis, Minnesota 55455
Oladi Bentho, MD
Saint Cloud, Minnesota 56303
Suri Muhammad Fareed, MD
Saint Louis Park, Minnesota 55426
Darwin Ramirez Abreu, MD
Saint Paul, Minnesota 55101
Darwin Ramirez-Abreu, MD
Jackson, Mississippi 39216
Chad Washington
Saint Louis, Missouri 63110
Renee Van Stavern, MD
Springfield, Missouri 65807
Benjamin Lisle, MD
Omaha, Nebraska 68105
Pierre Fayad, MD
Albuquerque, New Mexico 87106
Tarun Girotra, MD
Bronx, New York 10467
Kathryn Kirchoff, MD
Brooklyn, New York 11203
Susan Law, MD
Brooklyn, New York 11215
Yahya Atalay, MD
Brooklyn, New York 11219
Sanskriti Mishra, MD
Brooklyn, New York 11220
Jennifer Frontera
Buffalo, New York 14202
Amit Kandel, MD
Manhasset, New York 11030
Tania Rebeiz, MD
New York, New York 10019
Neha Dangayach, MD
New York, New York 10029
Neha Dangayach, MD
New York, New York 10032
Imama Naqvi, MD
New York, New York 10065
Hooman Kamel, MD
Poughkeepsie, New York 12601
Paul Wright, MD
Rochester, New York 14642
Curtis Benesch, MD
Stony Brook, New York 11794
Jason Mathew, MD
Syracuse, New York 13210
Karen Albright
Chapel Hill, North Carolina 27514
David Huang, MD
Charlotte, North Carolina 28204
Nikhil Patel, MD
Greensboro, North Carolina 27401
Pramod Sethi, MD
Winston-Salem, North Carolina 27157
Stacey Wolfe, MD
Akron, Ohio 44307
Ahmed Itrat, MD
Cincinnati, Ohio 45219
Daniel Woo
Cleveland, Ohio 44106
Abhishek Ray, MD
Cleveland, Ohio 44109
Agnieszka Ardelt
Cleveland, Ohio 44195
Blake Buletko
Columbus, Ohio 43210
Yousef Hannawi, MD
Columbus, Ohio 43214
Vivek Rai, MD
Oklahoma City, Oklahoma 73104
Evgeny Sidorov
Tulsa, Oklahoma 74104
Rahul Rahangdale, MD
Portland, Oregon 92739
Wayne Clark
Portland, Oregon 97213
John Zurasky
Springfield, Oregon 97477
Elaine Skalabrin, MD
Abington, Pennsylvania 19001
Larami MacKenzie
Allentown, Pennsylvania 18103
Danville, Pennsylvania 17822
Clemens Schirmer, MD
Philadelphia, Pennsylvania 19104
Christopher Favilla, MD
Philadelphia, Pennsylvania 19107
Diana Tzeng, MD
Philadelphia, Pennsylvania 19140
Paul Katz, MD
Pittsburgh, Pennsylvania 15213
Marcelo Rocha
Providence, Rhode Island 02903
Michael Reznik
Charleston, South Carolina 29425
Christine Holmstedt, MD
Greenville, South Carolina 29605
Sanjeev Sivakumar, MD
Memphis, Tennessee 38104
Balaji Krishnaiah, MD
Nashville, Tennessee 37232
Deborah Kerrigan, MD
Austin, Texas 78705
Angel Pulido, MD
Dallas, Texas 75390
Bappaditya Ray
Houston, Texas 77030
Chethan Venkatasubba Rao, MD
Houston, Texas 77030
Britz Britz, MD
Houston, Texas 77030
Andrew Barreto, MD
San Antonio, Texas 78229
Reza Behrouz, MD
Salt Lake City, Utah 84112
Safdar Ansari, MD
Burlington, Vermont 05401
Chris Commichau
Charlottesville, Virginia 22908
Brad Worral, MD
Falls Church, Virginia 22042
Saqib Chaudhry, MD
Richmond, Virginia 23298
Shraddha Mainali, MD
Seattle, Washington 98101
Steven O'Donnell, MD
Seattle, Washington 98104
David Tirschwell, MD
Morgantown, West Virginia 26506
Amelia Adcock, MD
Milwaukee, Wisconsin 53226
Hatim Attar, MD
More Details
- NCT ID
- NCT03907046
- Status
- Recruiting
- Sponsor
- Yale University
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.