- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05047172
Vergelijking van antistollings- en antibloedplaatjestherapieën voor intracraniale vasculaire atherostenose (CAPTIVA)
Vergelijking van antistollings- en antibloedplaatjestherapieën voor intracraniële vasculaire atherostenose (CAPTIVA)
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
The proposed study is relevant to public health because narrowing of brain arteries is one of the most common causes of stroke worldwide. Compelling evidence suggests novel antithrombotic medications could reduce the rate of stroke in patients with narrowed brain arteries. The proposed study will directly compare novel antithrombotic medications to standard care antiplatelet medications for preventing stroke and death from vascular causes in patients with narrowed brain arteries.
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- University of Alabama Hospital
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Mobile, Alabama, Verenigde Staten, 36604
- University of South Alabama University Hospital
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85013
- St. Joseph's Hospital and Medical Center
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California
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Carmichael, California, Verenigde Staten, 95608
- Mercy San Juan Medical Center
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Chula Vista, California, Verenigde Staten, 91910
- The Neuron Clinic - Chula Vista
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Fontana, California, Verenigde Staten, 92335
- Kaiser Permanente Fontana Medical Center
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Long Beach, California, Verenigde Staten, 90806
- Long Beach Memorial Medical Center
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Los Alamitos, California, Verenigde Staten, 90720
- Los Alamitos Medical Center
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Los Angeles, California, Verenigde Staten, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Verenigde Staten, 90095
- Ronald Reagan UCLA Medical Center, Los Angeles, CA
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Orange, California, Verenigde Staten, 92868
- UC Irvine Medical Center
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Sacramento, California, Verenigde Staten, 95817
- UC Davis Medical Center
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Salinas, California, Verenigde Staten, 93901
- Salinas Valley Memorial Hospital
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San Diego, California, Verenigde Staten, 92103
- UCSD Medical Center - Hillcrest Hospital
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Torrance, California, Verenigde Staten, 90503
- Providence Little Company of Mary Medical Center Torrance
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Hospital
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Grand Junction, Colorado, Verenigde Staten, 81501
- St. Mary's Medical Center
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Connecticut
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Hartford, Connecticut, Verenigde Staten, 06102
- Hartford Hospital
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New Haven, Connecticut, Verenigde Staten, 06520
- Yale New Haven Hospital
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20010
- MedStar Washington Hospital Center
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Florida
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Clearwater, Florida, Verenigde Staten, 33756
- Morton Plant Hospital
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Gainesville, Florida, Verenigde Staten, 32608
- UF Health Shands Hospital
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Jacksonville, Florida, Verenigde Staten, 32224
- Mayo Clinic
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Jacksonville, Florida, Verenigde Staten, 32207
- Baptist Medical Center Jacksonville
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Miami, Florida, Verenigde Staten, 33136
- Jackson Memorial Hospital
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Port Saint Lucie, Florida, Verenigde Staten, 34987
- Cleveland Clinic Tradition Hospital
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Tampa, Florida, Verenigde Staten, 33606
- Tampa General Hospital
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, Verenigde Staten, 30303
- Emory University Hospital
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Augusta, Georgia, Verenigde Staten, 30912
- Augusta University Medical Center
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Illinois
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Carbondale, Illinois, Verenigde Staten, 62901
- Memorial Hospital of Carbondale
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Chicago, Illinois, Verenigde Staten, 60612
- Rush University Medical Center
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois Hospital
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Chicago, Illinois, Verenigde Staten, 60637
- University of Chicago Medical Center
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Evanston, Illinois, Verenigde Staten, 60201
- Evanston Hospital
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Oak Lawn, Illinois, Verenigde Staten, 60453
- Advocate Christ Medical Center
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Rockford, Illinois, Verenigde Staten, 61114
- Javon Bea Hospital - Riverside
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- University of Kansas Hospital
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
- Baptist Health Lexington
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Lexington, Kentucky, Verenigde Staten, 40536
- University of Kentucky Hospital
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70121
- Ochsner Medical Center - Main Campus
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Verenigde Staten, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Verenigde Staten, 02118
- Boston Medical Center
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Worcester, Massachusetts, Verenigde Staten, 01655
- UMass Memorial Medical Center
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital
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Flint, Michigan, Verenigde Staten, 48532
- McLaren Flint
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Mount Clemens, Michigan, Verenigde Staten, 48043
- McLaren Macomb
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Wyoming, Michigan, Verenigde Staten, 49519
- Metro Health Hospital
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Minnesota
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Edina, Minnesota, Verenigde Staten, 55414
- M Health Fairview Southdale Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Abbott Northwestern Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55415
- M Health Fairview University of Minnesota Medical Center
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, Verenigde Staten, 65212
- University of Missouri Health Care
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St Louis, Missouri, Verenigde Staten, 62269
- Barnes Jewish Hospital
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68198
- University of Nebraska Medical Center
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New Jersey
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Camden, New Jersey, Verenigde Staten, 08103
- Cooper University Hospital
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Neptune City, New Jersey, Verenigde Staten, 07753
- Jersey Shore University Medical Center
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Ridgewood, New Jersey, Verenigde Staten, 07450
- Valley Hospital
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87106
- University of New Mexico Hospital
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New York
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Brooklyn, New York, Verenigde Staten, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Verenigde Staten, 11203
- Kings County Hospital Center
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Brooklyn, New York, Verenigde Staten, 11220
- NYU Langone Hospital - Brooklyn
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Buffalo, New York, Verenigde Staten, 14202
- Buffalo General Medical Center
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Lake Success, New York, Verenigde Staten, 11042
- North Shore University Hospital
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New York, New York, Verenigde Staten, 10029
- The Mount Sinai Hospital
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New York, New York, Verenigde Staten, 10021
- NYP Weill Cornell Medical Center
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New York, New York, Verenigde Staten, 10032
- NYP Columbia University Medical Center
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Rochester, New York, Verenigde Staten, 14642
- Strong Memorial Hospital
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The Bronx, New York, Verenigde Staten, 10467
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28207
- Carolinas Medical Center
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Durham, North Carolina, Verenigde Staten, 27710
- Duke University Hospital
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Greensboro, North Carolina, Verenigde Staten, 27405
- Moses H. Cone Memorial Hospital
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Greenville, North Carolina, Verenigde Staten, 27834
- ECU Health Medical Center
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest Baptist Medical Center
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Ohio
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Akron, Ohio, Verenigde Staten, 44307
- Cleveland Clinic Akron General
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Cincinnati, Ohio, Verenigde Staten, 45267
- University of Cincinnati Medical Center
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Cincinnati, Ohio, Verenigde Staten, 45220
- Good Samaritan Hospital
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic
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Cleveland, Ohio, Verenigde Staten, 44106
- UH Cleveland Medical Center
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Columbus, Ohio, Verenigde Staten, 43210
- OSU Wexner Medical Center
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Toledo, Ohio, Verenigde Staten, 43608
- Mercy St. Vincent Medical Center
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Toledo, Ohio, Verenigde Staten, 43606
- Toledo Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- OU Medical Center
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Oregon
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Portland, Oregon, Verenigde Staten, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, Verenigde Staten, 97239
- Oregon Health & Science University Hospital
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Pennsylvania
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Abington, Pennsylvania, Verenigde Staten, 19001
- Jefferson Abington Hospital
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Altoona, Pennsylvania, Verenigde Staten, 16601
- UPMC Altoona
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Erie, Pennsylvania, Verenigde Staten, 16550
- UPMC Hamot
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Verenigde Staten, 19140
- Temple University Hospital, Philadelphia
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- UPMC Presbyterian Hospital
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- Medical University of South Carolina University Hospital
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Columbia, South Carolina, Verenigde Staten, 29203
- Prisma Health Richland Hospital
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Greenville, South Carolina, Verenigde Staten, 29605
- Prisma Health Greenville Memorial Hospital
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38104
- Methodist University Hospital
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Texas
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Galveston, Texas, Verenigde Staten, 77555
- University of Texas Medical Branch
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Houston, Texas, Verenigde Staten, 77030
- Houston Methodist Hospital
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Houston, Texas, Verenigde Staten, 77030
- Memorial Hermann Texas Medical Center
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Lubbock, Texas, Verenigde Staten, 79410
- Covenant Medical Center
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Plano, Texas, Verenigde Staten, 75075
- Medical City Plano
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San Antonio, Texas, Verenigde Staten, 78229
- University of Texas Health Science Center San Antonio
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Tyler, Texas, Verenigde Staten, 75708
- UT Health Tyler
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401
- The University of Vermont Medical Center
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22903
- UVA Medical Center
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Falls Church, Virginia, Verenigde Staten, 22042
- Inova Fairfax Hospital
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Roanoke, Virginia, Verenigde Staten, 24011
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- Harborview Medical Center
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Seattle, Washington, Verenigde Staten, 98122
- Swedish Medical Center - Cherry Hill Campus
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Acute focal symptoms or signs of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting greater than or equal to 24 hours that occurred within 30 days prior to randomization
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Index stroke is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, middle cerebral artery (M1 or M2), vertebral artery (V4), basilar artery, posterior cerebral artery (P1), or anterior cerebral artery (A1)) documented by CTA, MRA, or catheter angiography
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Modified Rankin Scale score of ≤ 4, at time of consent
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Ability to swallow pills
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At least 30 years of age, inclusive, at time of consent
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Subjects 30-49 years of age are required to meet at least ONE of the following additional criteria below to qualify for the study:
- diabetes treated with insulin for at least 15 years
- at least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL < 40 mg/dl or fasting triglycerides > 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; any of the following vascular events occurring in a parent or sibling who was < 55 years of age for men or < 65 years of age for women at the time of the event: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery for atherosclerotic disease
- personal history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
- any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
- aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
- any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic
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Negative pregnancy test in a female who has had any menses in the last 18 months and has not had surgery that would make her unable to become pregnant
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Subject is willing and able to return for all follow-up evaluations required by the protocol
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Subject is available by phone
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Subject understands the purpose and requirements of the study and can make him/herself understood
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Subject has provided informed consent (use of a LAR is not permitted)
Exclusion Criteria:
- Previous treatment of qualifying intracranial artery with a stent, angioplasty, or other mechanical device, including mechanical thrombectomy for the qualifying stroke, or plan to perform one of these procedures
- Plan to perform concomitant endarterectomy, angioplasty or stenting of an extracranial vessel tandem to the symptomatic intracranial stenosis
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours prior to randomization
- Progressive neurological signs within 24 hours prior to randomization
- History of spontaneous non-traumatic intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
- Intracranial arterial stenosis due to: arterial dissection; MoyaMoya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, left atrial spontaneous echo contrast
- Known allergy or contraindication to aspirin, rivaroxaban, clopidogrel, or ticagrelor
- Uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), active peptic ulcer disease, major systemic hemorrhage within 30 days prior to randomization, active bleed or bleeding diathesis, platelets < 100,000, hematocrit < 30, INR > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, severe liver impairment (AST or ALT > 3 x normal, cirrhosis), or CrCl < 15 mL/min or on dialysis
- Major surgery (including stenting of any vessel; open femoral, aortic, or carotid surgery; or cardiac surgery) within previous 30 days prior to randomization or planned in the next 90 days after randomization
- Any condition other than intracranial arterial stenosis that requires the subject to take any antithrombotic medication other than aspirin (NOTE: exceptions allowed for subcutaneous heparin or enoxaparin for deep vein thrombosis (DVT) prophylaxis)
- Dementia or psychiatric problem that prevents the subject from following an outpatient program reliably
- Co-morbid conditions that may limit survival to less than 12 months
- Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study, or currently breastfeeding
- Current or anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or CYP3A4 substrates that cannot be stopped for the course of this study
- Enrollment in another study that would conflict with the current study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental Arm: Ticagrelor and Aspirin
Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily) |
ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Andere namen:
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed. |
|
Actieve vergelijker: Standard of Care Arm: Clopidogrel and Aspirin
Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily) |
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed. clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
Andere namen:
|
|
Experimenteel: Experimental Arm: Rivaroxaban and Aspirin
Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily) |
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed. low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants with parenchymal ICH or non-ICH major hemorrhage
Tijdsspanne: Up to 12 months
|
Non-ICH major hemorrhage is derived from the International Society on Thrombosis and Haemostasis (ISTH) criteria consisting of any of the following:
|
Up to 12 months
|
|
Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death
Tijdsspanne: Up to 12 months
|
The definition of ischemic stroke is the American Heart Association definition that includes acute focal signs or symptoms of cerebral, spinal cord, or retinal involvement of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting greater than or equal to 24 hours. |
Up to 12 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Brian L. Hoh, MD, MBA, University of Florida
- Hoofdonderzoeker: Marc I. Chimowitz, MBChB, Medical University of South Carolina
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Vaatziekten
- Hart-en vaatziekten
- Arteriosclerose
- Arteriële occlusieve ziekten
- Intracraniële arteriële aandoeningen
- Hartinfarct
- Intracraniële arteriosclerose
- Zwavelverbindingen
- Organische chemicaliën
- Pyridines
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Nucleïnezuren, nucleotiden en nucleosiden
- Koolwaterstoffen
- Koolwaterstoffen, cyclisch
- Koolwaterstoffen, aromatisch
- Purines
- Fenolen
- Benzeenderivaten
- Nucleosiden
- Ribonucleosiden
- Morfolines
- Oxazines
- Thiophenes
- Salicyen
- Hydroxybenzoates
- Adenosine
- Purine nucleosiden
- Ticlopidine
- Thienopyridines
- Ticagrelor
- Clopidogrel
- Rivaroxaban
- Aspirine
Andere studie-ID-nummers
- CED000000522
- AWD10099 (Andere identificatie: UFIRST)
- U01NS117450 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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