- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03192215
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)
June 6, 2023 updated by: Randolph S. Marshall, MD, Columbia University
Objectives
- Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.
- Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
Study Overview
Detailed Description
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause.
Eleven hundred subjects will be recruited over 2.5 years at up to 200 sites in and out of the NINDS StrokeNet consortium.
Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
Study Type
Interventional
Enrollment (Actual)
1015
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
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Calgary, Alberta, Canada, T2N2T9
- University of Calgary - Foothills Medical Centre
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Edmonton, Alberta, Canada, T6G 2G3
- University of Alberta Hospital
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Lethbridge, Alberta, Canada, T1J 0N9
- Neurologic Research Center
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 1T2
- Kelowna General Hospital
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Manitoba
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Brandon, Manitoba, Canada, R7A 2B3
- Brandon Regional Health Center
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Ontario
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Hamilton, Ontario, Canada, L8L2X2
- Hamilton General Hospital
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Kingston, Ontario, Canada, K7L2V7
- Kingston General Hospital
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Center
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Center
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Quebec
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Québec, Quebec, Canada, G1J 1Z4-65543
- Enfant-Jesus Hospital
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N0W8
- Royal University Hospital
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-
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama
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Mobile, Alabama, United States, 36604
- University of South Alabama University Hospital
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Arizona
-
Chandler, Arizona, United States, 85224
- Chandler Regional Medical Center Chandler, AZ
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Phoenix, Arizona, United States, 85013
- St. Joseph's Hospital and Medical Center
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Tucson, Arizona, United States, 85724
- Banner University Medical Center - Tucson
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California
-
Carmichael, California, United States, 95608
- Mercy San Juan Medical Center (Dignity Health)
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Castro Valley, California, United States, 94546
- Eden Medical Center
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Downey, California, United States, 90242
- Rancho Los Amigos National Rehabilitation Center
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Fountain Valley, California, United States, 92708
- Fountain Valley Regional Hospital and Medical Center
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Fresno, California, United States, 93721
- Community Regional Medical Center
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La Jolla, California, United States, 92037
- UCSD Health La Jolla
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La Mesa, California, United States, 92123
- Sharp Grossmont Hospital
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Long Beach, California, United States, 90806
- Long Beach Memorial Medical Center
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Los Alamitos, California, United States, 90720
- Los Alamitos Medical Center
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Los Angeles, California, United States, 90095
- Ronald Reagan UCLA Medical Center
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Los Angeles, California, United States, 90033
- Keck Hospital of USC
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Los Angeles, California, United States, 90027
- Kaiser Permanente
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Los Angeles, California, United States, 90033
- Los Angeles County- USC Medical Center
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Los Angeles, California, United States, 90073
- VA Greater Los Angeles - West LA VA Medical Center
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Orange, California, United States, 92868
- UC Irvine Medical Center
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Sacramento, California, United States, 95816
- Sutter Medical Center
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Salinas, California, United States, 93901
- Salinas Valley Memorial Hospital
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San Diego, California, United States, 92123
- Sharp Memorial Hospital
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San Diego, California, United States, 91910
- Scripps Mercy
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San Diego, California, United States, 92103
- UCSD Medical Center - Hillcrest Hospital
-
San Diego, California, United States, 92123
- Kaiser Permanent San Diego Medical Center
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San Francisco, California, United States, 94143
- UCSF Medical Center
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San Francisco, California, United States, 94110
- San Francisco General
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San Jose, California, United States, 95124
- Good Samaritan
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Stanford, California, United States, 94305
- Stanford University Medical Center
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Colorado
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Englewood, Colorado, United States, 80113
- Swedish Medical Center
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Grand Junction, Colorado, United States, 81501
- St. Mary's Medical Center
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- St. Vincent's Medical Center
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Hartford, Connecticut, United States, 06102-5037
- Hartford Hospital
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New Haven, Connecticut, United States, 06520
- Yale New Haven Hospital
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington
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Washington, District of Columbia, United States, 20007
- Med-star Georgetown Univ.
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Florida
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Boca Raton, Florida, United States, 33486
- Boca Raton Regional Hospital
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Gainesville, Florida, United States, 32610
- UF Health Shands
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
Jacksonville, Florida, United States, 32207
- Baptist Medical Center Jacksonville
-
Miami, Florida, United States, 33176
- Baptist Hospital of Miami
-
Miami, Florida, United States, 33136
- Jackson Memorial
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Miami, Florida, United States, 33136
- Univ. Miami Hospital
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Sarasota, Florida, United States, 34239
- Intercoastal Medical Group - Hyde Park
-
Tampa, Florida, United States, 33606
- Tampa General
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
-
Atlanta, Georgia, United States, 30303
- Grady Memorial
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Hawaii
-
Honolulu, Hawaii, United States, 96813
- The Queen's Medical Center
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Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
Chicago, Illinois, United States, 60612
- University of Illinois
-
Chicago, Illinois, United States, 60612
- Rush University
-
Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
-
Springfield, Illinois, United States, 62702
- Southern Illinois University Memorial Medical Center
-
Springfield, Illinois, United States, 62769
- St. John's Hospital (Prairie Research)
-
Winfield, Illinois, United States, 60190
- Central DuPage Hospital
-
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Iowa
-
Des Moines, Iowa, United States, 50309
- Multi-Specialty - Methodist Plaza/Unity Point
-
Iowa City, Iowa, United States, 52242
- University of Iowa
-
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Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas
-
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Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky
-
Lexington, Kentucky, United States, 40503
- Baptist Health Lexington
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Louisville, Kentucky, United States, 40202
- University of Louisville Hospital
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Louisiana
-
New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
-
-
Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical
-
Boston, Massachusetts, United States, 20115
- Brigham & Womens Hospital
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Burlington, Massachusetts, United States, 01805
- Lahey Hospital & Medical Center
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Worcester, Massachusetts, United States, 01655
- U Mass Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan University Hospital
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Ann Arbor, Michigan, United States, 48109
- VA Ann Arbor Healthcare System
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201
- Detroit Receiving Hospital
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Flint, Michigan, United States, 48532
- McLaren Flint
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health
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Grand Rapids, Michigan, United States, 49503
- Mercy Health St. Mary's
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Mount Clemens, Michigan, United States, 48043
- McLaren Macomb, Mount Clemens, MI
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Petoskey, Michigan, United States, 49770
- McLaren Northern Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Abbott Northwestern Hospital
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Minneapolis, Minnesota, United States, 55415
- Hennepin County
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Minneapolis, Minnesota, United States, 55455
- Univ. of Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Saint Paul, Minnesota, United States, 55102
- United Hospital
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Saint Paul, Minnesota, United States, 55101
- Regions Hospital, St. Paul
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital of Kansas City
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Saint Louis, Missouri, United States, 63110
- Barnes Jewish Hospital
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Saint Louis, Missouri, United States, 63104
- St. Louis University Hospital
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Springfield, Missouri, United States, 65807
- Cox Medical Center South
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska
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Omaha, Nebraska, United States, 68124
- CHI Health Immanuel
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital,
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New Brunswick, New Jersey, United States, 08901
- Robert Wood Johnson
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Pennington, New Jersey, United States, 08534
- Capital Health Medical Center Hopewell
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- Univ. New Mexico
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Brooklyn, New York, United States, 11219
- Maimonides Medical Center
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Brooklyn, New York, United States, 11203
- Kings County Hospital
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Brooklyn, New York, United States, 11220
- NYU Langone Hospital - Brooklyn
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Brooklyn, New York, United States, 11215-3609
- New York Presbyterian - Brooklyn Methodist Hospital
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Brooklyn, New York, United States, 11234
- Mount Sinai Beth Israel Brooklyn
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Buffalo, New York, United States, 14203
- Buffalo General Medical Center
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Manhasset, New York, United States, 11042
- North Shore University Hospital
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10065
- Weill Cornell Medicine
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New York, New York, United States, 10019
- Mount Sinai West
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New York, New York, United States, 10075
- Lenox Hill Hospital
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New York, New York, United States, 10003
- NYU Langone
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Rochester, New York, United States, 14642
- Strong Memorial Hospital
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North Carolina
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Greensboro, North Carolina, United States, 27405
- Moses H. Cone Memorial Hospital
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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North Dakota
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Fargo, North Dakota, United States, 58122
- Sanford Medical Center Fargo
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Ohio
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Akron, Ohio, United States, 44307
- Akron General Medical Center
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, United States, 44106
- UH Cleveland Medical Center
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Cleveland, Ohio, United States, 44106
- Louis Stokes VA Medical Center
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Columbus, Ohio, United States, 43210
- OSU Wexner
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Columbus, Ohio, United States, 43214
- Ohio Health Riverside - Riverside Methodist Hospital
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Dayton, Ohio, United States, 45409
- Miami Valley Hospita
-
Toledo, Ohio, United States, 43608
- Mercy St Vincent Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- OU Medical Center Oklahoma
-
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Oregon
-
Portland, Oregon, United States, 97227
- Legacy Emanuel
-
Portland, Oregon, United States, 97239
- Oregon Health and Sciences
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- LeHigh Valley Hospital
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Altoona, Pennsylvania, United States, 16601
- UPMC Altoona
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Lancaster, Pennsylvania, United States, 17602
- Lancaster General Hospital
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University
-
Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC Presbyterian
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
Columbia, South Carolina, United States, 29203
- Prisma Health Richland Hospital (formerly Palmetto Health)
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Greenville, South Carolina, United States, 29605
- Prisma Health Greenville Memorial Hospital
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Tennessee
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Memphis, Tennessee, United States, 38104
- Methodist University Hospital
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Nashville, Tennessee, United States, 37212
- Vanderbilt
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Harlingen, Texas, United States, 78550
- Valley Bapist
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Houston, Texas, United States, 77030
- Memorial Hermann Texas Medical Center
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Houston, Texas, United States, 77030
- Baylor College College of Medicine
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San Antonio, Texas, United States, 78229
- Univ of Texas Health Science Center San Antonio
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Temple, Texas, United States, 76508
- Scott & White Memorial Hospital - Temple
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The Woodlands, Texas, United States, 77380
- Memorial Hermann The Woodlands Hospital
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Utah
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Murray, Utah, United States, 84107
- Intermountain Medical Center
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Provo, Utah, United States, 84604
- Utah Valley Regional Medical Center
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Salt Lake City, Utah, United States, 84132
- Univ of Utah
-
Salt Lake City, Utah, United States, 84148
- George E Whalen VA
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Virginia
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Charlottesville, Virginia, United States, 22908
- UVA Medical Center
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Richmond, Virginia, United States, 23226
- Bon Secours St. Mary's Hospital
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Washington
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Olympia, Washington, United States, 98506
- Providence St. Peter Hospital
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Seattle, Washington, United States, 98108
- Puget Sound VA
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Seattle, Washington, United States, 98122
- Swedish Medical Center - Cherry Hill Campus
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West Virginia
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Morgantown, West Virginia, United States, 26506-9180
- WVU Healthcare Ruby Memorial
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 45 years.
- Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
- Modified Rankin Scale (MRS) score ≤ 4.
- Ability to be randomized within 3 to 180 days after stroke onset.
ESUS, defined as all of the following:
- Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
- Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
- No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator.
- No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.
Exclusion Criteria:
- History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
- Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
- Need for antiplatelet agent, such as aspirin or clopidogrel
- History of spontaneous intracranial hemorrhage.
- Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion.
- Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
- Clinically significant bleeding diathesis.
- Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L).
- Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids).
- At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence.
- Known allergy or intolerance to aspirin or apixaban.
- Concomitant participation in another clinical trial involving a drug or acute stroke intervention.
- Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial.
- Inability of either participant or surrogate to provide written, informed consent for trial participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active agent: Apixaban
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
|
5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
Other Names:
|
Active Comparator: Active control: Aspirin
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
|
Aspirin 81 mg by mouth once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of recurrent stroke
Time Frame: 7 years
|
Recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type)
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of recurrent ischemic stroke or systemic embolism
Time Frame: Up to 7 years
|
Secondary efficacy outcome A
|
Up to 7 years
|
Incidence of recurrent stroke of any type plus death from any cause
Time Frame: Up to 7 years
|
Secondary efficacy outcome B
|
Up to 7 years
|
Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke).
Time Frame: Up to 7 years
|
Primary safety outcome A
|
Up to 7 years
|
Incidence of major hemorrhage other than intracranial hemorrhage
Time Frame: Up to 7 years
|
Primary safety outcome B
|
Up to 7 years
|
Incidence of death from any cause
Time Frame: Up to 7 years
|
Secondary safety outcome
|
Up to 7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Randolph S Marshall, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kamel H, Okin PM, Elkind MS, Iadecola C. Atrial Fibrillation and Mechanisms of Stroke: Time for a New Model. Stroke. 2016 Mar;47(3):895-900. doi: 10.1161/STROKEAHA.115.012004. Epub 2016 Jan 19. No abstract available.
- Yaghi S, Kamel H, Elkind MS. Potential new uses of non-vitamin K antagonist oral anticoagulants to treat and prevent stroke. Neurology. 2015 Sep 22;85(12):1078-84. doi: 10.1212/WNL.0000000000001817. Epub 2015 Jul 17.
- Kamel H, Okin PM, Longstreth WT Jr, Elkind MS, Soliman EZ. Atrial cardiopathy: a broadened concept of left atrial thromboembolism beyond atrial fibrillation. Future Cardiol. 2015 May;11(3):323-31. doi: 10.2217/fca.15.22.
- Yaghi S, Moon YP, Mora-McLaughlin C, Willey JZ, Cheung K, Di Tullio MR, Homma S, Kamel H, Sacco RL, Elkind MS. Left atrial enlargement and stroke recurrence: the Northern Manhattan Stroke Study. Stroke. 2015 Jun;46(6):1488-93. doi: 10.1161/STROKEAHA.115.008711. Epub 2015 Apr 23.
- Longstreth WT Jr, Kronmal RA, Thompson JL, Christenson RH, Levine SR, Gross R, Brey RL, Buchsbaum R, Elkind MS, Tirschwell DL, Seliger SL, Mohr JP, deFilippi CR. Amino terminal pro-B-type natriuretic peptide, secondary stroke prevention, and choice of antithrombotic therapy. Stroke. 2013 Mar;44(3):714-9. doi: 10.1161/STROKEAHA.112.675942. Epub 2013 Jan 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2018
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
April 17, 2023
Study Registration Dates
First Submitted
June 16, 2017
First Submitted That Met QC Criteria
June 16, 2017
First Posted (Actual)
June 20, 2017
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Heart Diseases
- Stroke
- Ischemic Stroke
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Aspirin
- Apixaban
Other Study ID Numbers
- AAAR4607
- 1U01NS095869-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
IPD Sharing Time Frame
As per NIH/NINDS requirements.
IPD Sharing Access Criteria
All items required by NIH/NINDS will be publicly shared.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
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University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
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Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
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University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Apixaban
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PfizerBristol-Myers SquibbCompleted
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Bristol-Myers SquibbCompleted
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Assistance Publique - Hôpitaux de ParisBristol-Myers SquibbActive, not recruitingCancer-associated ThrombosisFrance, Spain, Netherlands, Belgium, Austria, Greece, Switzerland, Canada, Italy, Poland, United Kingdom
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The Affiliated Hospital of Qingdao UniversityCompleted
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Baim Institute for Clinical ResearchBristol-Myers SquibbCompletedAtrial FibrillationUnited States
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Portola PharmaceuticalsCompleted
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Doasense GmbHActive, not recruitingAnticoagulant TherapyGermany
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University Hospital, GenevaSunnybrook Health Sciences CentreNot yet recruitingDeep Vein Thrombosis
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Universitaire Ziekenhuizen KU LeuvenRecruitingAnticoagulation | Short Bowel SyndromeBelgium
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University Hospital, CaenUniversity Hospital, RouenCompletedPeritoneal Dialysis | Chronic Renal InsufficiencyFrance