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
University of Alabama Hospital
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Contact:
Angela Shapshak, MD
Angela Shapshak, MD
University of South Alabama University Hospital
Mobile, Alabama 36604
Mobile, Alabama 36604
Contact:
Taha Nisar, MD
Taha Nisar, MD
Banner University Medical Center
Tucson, Arizona 85719
Tucson, Arizona 85719
Contact:
Firas Kaddouh, MD
Firas Kaddouh, MD
Mercy San Juan Medical Center
Carmichael, California 95608
Carmichael, California 95608
Contact:
Lucian Maidan
Lucian Maidan
Arrowhead Regional Medical Center
Colton, California 92324
Colton, California 92324
Contact:
Dan Miulli, MD
Dan Miulli, MD
Kaiser Permanente Fontana Medical Center
Fontana, California 92335
Fontana, California 92335
Contact:
Vaninder Chhabra
Vaninder Chhabra
Los Alamitos Medical Center
Los Alamitos, California 90720
Los Alamitos, California 90720
Contact:
Nirav Patel, MD
Nirav Patel, MD
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Contact:
Harsimran Brara, MD
Harsimran Brara, MD
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Konrad Schlick, MD
Konrad Schlick, MD
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
Latisha Sharma, MD
Latisha Sharma, MD
Doctors Medical Center Modesto, Modesto, CA
Modesto, California 95350
Modesto, California 95350
Contact:
James Jaffe, MD
James Jaffe, MD
UC Irvine Medical Center
Orange, California 92868
Orange, California 92868
Contact:
Wengui Yu, MD
Wengui Yu, MD
Desert Regional Medical Center
Palm Springs, California 92262
Palm Springs, California 92262
Contact:
Kevin Attenhofer, MD
Kevin Attenhofer, MD
Huntington Memorial Hospital
Pasadena, California 91105
Pasadena, California 91105
Contact:
Arib Ohanian, MD
Arib Ohanian, MD
Kaiser Permanente Redwood City Medical Center, Redwood City, CA
Redwood City, California 94063
Redwood City, California 94063
Contact:
Sheila Chan, MD
Sheila Chan, MD
UC Davis Medical Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Kwan Ng, MD
Kwan Ng, MD
Kaiser Permanente Sacramento Medical Center
Sacramento, California 95825
Sacramento, California 95825
Contact:
Yekaterina Axelrod, MD
Yekaterina Axelrod, MD
San Francisco General Hospital
San Francisco, California 94110
San Francisco, California 94110
Contact:
Claude Hemphill, MD
Claude Hemphill, MD
Stanford University Medical Center
Stanford, California 94304
Stanford, California 94304
Contact:
Chitra Venkat, MD
Chitra Venkat, MD
PIH Health Hospital - Whittier
Whittier, California 90602
Whittier, California 90602
Contact:
Gautam Ganguly, MD
Gautam Ganguly, MD
Danbury Hospital
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Contact:
Charles Guardia, MD
Charles Guardia, MD
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Contact:
Mark Alberts, MD
Mark Alberts, MD
Yale New Haven Hospital
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Contact:
Guido Falcone, MD
Guido Falcone, MD
New Hanover Regional Medical Center
Wilmington, Delaware 28403
Wilmington, Delaware 28403
Contact:
James McKinney, MD
James McKinney, MD
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Contact:
Douglas Mayson, MD
Douglas Mayson, MD
Morton Plant Hospital
Clearwater, Florida 33756
Clearwater, Florida 33756
Contact:
Ajay Arora, MD
Ajay Arora, MD
Jackson Memorial Hospital
Miami, Florida 33136
Miami, Florida 33136
Contact:
Sebastian Koch
Sebastian Koch
Ascension Sacred Heart Pensacola
Pensacola, Florida 32504
Pensacola, Florida 32504
Contact:
Terry Neill, MD
Terry Neill, MD
Cleveland Clinic Tradition Hospital
Port Saint Lucie, Florida 34987
Port Saint Lucie, Florida 34987
Contact:
Marc Babi, MD
Marc Babi, MD
Tampa General Hospital
Tampa, Florida 33606
Tampa, Florida 33606
Contact:
Swetha Renati, MD
Swetha Renati, MD
St. Joseph's Hospital
Tampa, Florida 33607
Tampa, Florida 33607
Contact:
Abilash Haridas, MD
Abilash Haridas, MD
Grady Memorial Hospital
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Contact:
Daniel Schachter, MD
Daniel Schachter, MD
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Fadi Nahab, MD
Fadi Nahab, MD
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Contact:
Fenwick Nichols, MD
Fenwick Nichols, MD
WellStar Kennestone Hospital
Marietta, Georgia 30060
Marietta, Georgia 30060
Contact:
Christopher Horn, MD
Christopher Horn, MD
The Queen's Medical Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Kazuma Nakagawa, MD
Kazuma Nakagawa, MD
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Rima Dafer, MD
Rima Dafer, MD
University of Illinois Hospital
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Ali Alaraj, MD
Ali Alaraj, MD
University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Contact:
Elisheva Coleman, MD
Elisheva Coleman, MD
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Contact:
Sarkis Morales-Vidal, MD
Sarkis Morales-Vidal, MD
OSF St. Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
Contact:
Arun Talkad
Arun Talkad
Central DuPage Hospital
Winfield, Illinois 60190
Winfield, Illinois 60190
Contact:
Dhruvil Pandya, MD
Dhruvil Pandya, MD
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Contact:
Amir Shaban, MD
Amir Shaban, MD
University of Kansas Hospital
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Kyle Carpenter, MD
Kyle Carpenter, MD
University of Kentucky Hospital
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
Suhas Gangadhara, MD
Suhas Gangadhara, MD
Ochsner Medical Center - Main Campus
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Contact:
Richard Zweifler
Richard Zweifler
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Contact:
Emiliya Melkumova, MD
Emiliya Melkumova, MD
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Mariel Kozberg, MD
Mariel Kozberg, MD
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Contact:
Steven Feske, MD
Steven Feske, MD
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
Magdy Selim, MD
Magdy Selim, MD
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
Contact:
Colin James Culbertson, MD
Colin James Culbertson, MD
Baystate Medical Center
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
Contact:
Gottfried Schlaug, MD
Gottfried Schlaug, MD
UMass Memorial Medical Center
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
Contact:
Majaz Moonis, MD
Majaz Moonis, MD
University of Michigan University Hospital
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Contact:
Aditya Pandey
Aditya Pandey
McLaren Flint
Flint, Michigan 48532
Flint, Michigan 48532
Contact:
Bharath Naravetla, MD
Bharath Naravetla, MD
Trinity Health Saint Mary's
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Contact:
Muhammad Farooq, MD
Muhammad Farooq, MD
McLaren Macomb
Mount Clemens, Michigan 48043
Mount Clemens, Michigan 48043
Contact:
Bharath Naravetla, MD
Bharath Naravetla, MD
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
Contact:
David Rosenbaum, MD
David Rosenbaum, MD
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Contact:
Ganesh Asaithambi, MD
Ganesh Asaithambi, MD
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Contact:
Oladi Bentho, MD
Oladi Bentho, MD
St. Cloud Hospital
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Contact:
Muhammad Fareed Suri, MD
Muhammad Fareed Suri, MD
HealthPartners Methodist Hospital
Saint Louis Park, Minnesota 55426
Saint Louis Park, Minnesota 55426
Contact:
Darwin Ramirez Abreu, MD
Darwin Ramirez Abreu, MD
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
Contact:
Darwin Ramirez-Abreu, MD
Darwin Ramirez-Abreu, MD
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Contact:
Allison Strickland, MD
Allison Strickland, MD
Barnes Jewish Hospital
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Contact:
Yan Wang, MD
Yan Wang, MD
Cox Medical Center South
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
Benjamin Lisle, MD
Benjamin Lisle, MD
University of Nebraska Medical Center
Omaha, Nebraska 68105
Omaha, Nebraska 68105
Contact:
Marco Gonzalez Castellon, MD
Marco Gonzalez Castellon, MD
Overlook Medical Center
Summit, New Jersey 07901
Summit, New Jersey 07901
Contact:
John Hanna, MD
John Hanna, MD
University of New Mexico Hospital
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Contact:
Tarun Girotra, MD
Tarun Girotra, MD
Montefiore Medical Center
Bronx, New York 10467
Bronx, New York 10467
Contact:
Kathryn Kirchoff-Torres, MD
Kathryn Kirchoff-Torres, MD
Kings County Hospital Center
Brooklyn, New York 11203
Brooklyn, New York 11203
Contact:
Susan Law, MD
Susan Law, MD
Maimonides Medical Center
Brooklyn, New York 11219
Brooklyn, New York 11219
Contact:
Quingliang Wang, MD
Quingliang Wang, MD
NYU Langone Hospital - Brooklyn
Brooklyn, New York 11220
Brooklyn, New York 11220
Contact:
Jennifer Frontera
Jennifer Frontera
North Shore University Hospital
Manhasset, New York 11030
Manhasset, New York 11030
Contact:
Rohan Arora, MD
Rohan Arora, MD
Mount Sinai West
New York, New York 10019
New York, New York 10019
Contact:
Neha Dangayach, MD
Neha Dangayach, MD
The Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
Contact:
Neha Dangayach, MD
Neha Dangayach, MD
NYP Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Contact:
Imama Naqvi, MD
Imama Naqvi, MD
NYP Weill Cornell Medical Center
New York, New York 10065
New York, New York 10065
Contact:
Hooman Kamel, MD
Hooman Kamel, MD
Vassar Brothers Medical Center
Poughkeepsie, New York 12601
Poughkeepsie, New York 12601
Contact:
Paul Wright, MD
Paul Wright, MD
Strong Memorial Hospital
Rochester, New York 14642
Rochester, New York 14642
Contact:
Curtis Benesch, MD
Curtis Benesch, MD
Stony Brook University Hospital
Stony Brook, New York 11794
Stony Brook, New York 11794
Contact:
Jason Mathew, MD
Jason Mathew, MD
SUNY Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Julius-Gene Latorre, MD
Julius-Gene Latorre, MD
Westchester Medical Center
Valhalla, New York 10595
Valhalla, New York 10595
Contact:
Stephan Mayer, MD
Stephan Mayer, MD
University of North Carolina Medical Center
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Contact:
David Huang, MD
David Huang, MD
Forsyth Medical Center
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Contact:
Lauren Peruski, MD
Lauren Peruski, MD
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Stacey Wolfe, MD
Stacey Wolfe, MD
Cleveland Clinic Akron General
Akron, Ohio 44307
Akron, Ohio 44307
Contact:
Ahmed Itrat, MD
Ahmed Itrat, MD
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Contact:
Rob Stanton, MD
Rob Stanton, MD
Good Samaritan Hospital
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Contact:
Christopher Zammit, MD
Christopher Zammit, MD
UH Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Contact:
Abhishek Ray, MD
Abhishek Ray, MD
MetroHealth Medical Center
Cleveland, Ohio 44109
Cleveland, Ohio 44109
Contact:
Agnieszka Ardelt, MD
Agnieszka Ardelt, MD
Cleveland Clinic
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Contact:
Blake Buletko
Blake Buletko
OSU Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Contact:
Yousef Hannawi, MD
Yousef Hannawi, MD
Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Contact:
Vivek Rai, MD
Vivek Rai, MD
OU Medical Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Contact:
Evgeny Sidorov
Evgeny Sidorov
Ascension St. John Medical Center
Tulsa, Oklahoma 74104
Tulsa, Oklahoma 74104
Contact:
Rahul Rahangdale, MD
Rahul Rahangdale, MD
St. John Medical Center
Tulsa, Oklahoma 74104
Tulsa, Oklahoma 74104
Contact:
Rahul Rahangdale, MD
Rahul Rahangdale, MD
Oregon Health & Science University Hospital
Portland, Oregon 92739
Portland, Oregon 92739
Contact:
Wayne Clark
Wayne Clark
Providence St. Vincent Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Contact:
John Zurasky
John Zurasky
PeaceHealth Sacred Heart Medical Center - RiverBend
Springfield, Oregon 97477
Springfield, Oregon 97477
Contact:
Elaine Skalabrin, MD
Elaine Skalabrin, MD
Jefferson Abington Hospital
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
Contact:
Larami MacKenzie, MD
Larami MacKenzie, MD
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Contact:
Clemens Schirmer, MD
Clemens Schirmer, MD
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Contact:
Nandakumar Nagaraja, MD
Nandakumar Nagaraja, MD
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Contact:
Jens Witsch, MD
Jens Witsch, MD
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Contact:
Diana Tzeng, MD
Diana Tzeng, MD
Temple University Hospital
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Contact:
Paul Katz, MD
Paul Katz, MD
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Contact:
Marcelo Rocha
Marcelo Rocha
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Contact:
Torrey Birch, MD
Torrey Birch, MD
Medical University of South Carolina University Hospital
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Contact:
Christine Holmstedt, MD
Christine Holmstedt, MD
Greenville Hospital System
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Sanjeev Sivakumar, MD
Sanjeev Sivakumar, MD
Avera Research Institute
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
Contact:
Jonathon Cooke, MD
Jonathon Cooke, MD
Erlanger Health System
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37403
Contact:
Mounzer Kassab, MD
Mounzer Kassab, MD
Fort Sanders Regional Medical Center
Knoxville, Tennessee 37916
Knoxville, Tennessee 37916
Contact:
S. Arthur Moore, MD
S. Arthur Moore, MD
Methodist University Hospital
Memphis, Tennessee 38104
Memphis, Tennessee 38104
Contact:
Balaji Krishnaiah, MD
Balaji Krishnaiah, MD
Vanderbilt University Hospital
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Deborah Kerrigan, MD
Deborah Kerrigan, MD
Houston Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
Contact:
Britz Britz, MD
Britz Britz, MD
Memorial Hermann Texas Medical Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
Andrew Barreto, MD
Andrew Barreto, MD
University of Texas Health Science Center San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
Contact:
Reza Behrouz, MD
Reza Behrouz, MD
University of Utah Healthcare
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Contact:
Nabeel Chauhan, MD
Nabeel Chauhan, MD
The University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
Contact:
Chris Commichau
Chris Commichau
UVA Medical Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Contact:
Brad Worral, MD
Brad Worral, MD
Inova Fairfax Hospital
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Contact:
Saqib Chaudhry, MD
Saqib Chaudhry, MD
VCU Medical Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Contact:
Shraddha Mainali, MD
Shraddha Mainali, MD
Harborview Medical Center
Seattle, Washington 98104
Seattle, Washington 98104
Contact:
David Tirschwell, MD
David Tirschwell, MD
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington 98122
Seattle, Washington 98122
Contact:
James Bartscher, MD
James Bartscher, MD
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Contact:
Amelia Adcock, MD
Amelia Adcock, MD
Froedtert Hospital
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Hatim Attar, MD
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.