Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)

Who is this study for? Patients with intracranial vascular atherostenosis
Status: Recruiting
Location: See all (129) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• 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

• 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

• Modified Rankin Scale score of ≤ 4, at time of consent

• Ability to swallow pills

• At least 30 years of age, inclusive, at time of consent

• 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

• 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

• Subject is willing and able to return for all follow-up evaluations required by the protocol

• Subject is available by phone

• Subject understands the purpose and requirements of the study and can make him/herself understood

• Subject has provided informed consent (use of a LAR is not permitted)

Locations
United States
Alabama
University of Alabama Hospital
RECRUITING
Birmingham
University of South Alabama University Hospital
RECRUITING
Mobile
Arizona
Mayo Clinic
RECRUITING
Phoenix
St. Joseph's Hospital and Medical Center
RECRUITING
Phoenix
HonorHealth Scottsdale Osborn Medical Center
WITHDRAWN
Scottsdale
Banner University Medical Center - Tucson Campus
WITHDRAWN
Tucson
California
Mercy San Juan Medical Center
RECRUITING
Carmichael
The Neuron Clinic - Chula Vista
RECRUITING
Chula Vista
Kaiser Permanente Fontana Medical Center
RECRUITING
Fontana
UCSD Health La Jolla
WITHDRAWN
La Jolla
Long Beach Memorial Medical Center
RECRUITING
Long Beach
Los Alamitos Medical Center
RECRUITING
Los Alamitos
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center, Los Angeles, CA
TERMINATED
Los Angeles
UC Irvine Medical Center
TERMINATED
Orange
UC Davis Medical Center
RECRUITING
Sacramento
Salinas Valley Memorial Hospital
TERMINATED
Salinas
UCSD Medical Center - Hillcrest Hospital
TERMINATED
San Diego
Providence Little Company of Mary Medical Center Torrance
RECRUITING
Torrance
PIH Health Hospital
WITHDRAWN
Whittier
Colorado
University of Colorado Hospital
RECRUITING
Aurora
St. Mary's Medical Center
RECRUITING
Grand Junction
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale New Haven Hospital
RECRUITING
New Haven
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Morton Plant Hospital
RECRUITING
Clearwater
Broward Health Medical Center
RECRUITING
Fort Lauderdale
UF Health Shands Hospital
RECRUITING
Gainesville
Baptist Medical Center Jacksonville
RECRUITING
Jacksonville
Mayo Clinic
RECRUITING
Jacksonville
Jackson Memorial Hospital
RECRUITING
Miami
Cleveland Clinic Tradition Hospital
RECRUITING
Port Saint Lucie
Intercoastal Medical Group - Clinical Research
WITHDRAWN
Sarasota
Tampa General Hospital
TERMINATED
Tampa
Georgia
Emory University Hospital
RECRUITING
Atlanta
Grady Memorial Hospital
RECRUITING
Atlanta
Augusta University Medical Center
TERMINATED
Augusta
Iowa
University of Iowa Hospitals & Clinics
WITHDRAWN
Iowa City
Illinois
NCH Hospital
WITHDRAWN
Arlington Heights
Memorial Hospital of Carbondale
RECRUITING
Carbondale
Rush University Medical Center
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
University of Illinois Hospital
RECRUITING
Chicago
Evanston Hospital
RECRUITING
Evanston
Advocate Christ Medical Center
TERMINATED
Oak Lawn
Javon Bea Hospital - Riverside
RECRUITING
Rockford
Kansas
University of Kansas Hospital
RECRUITING
Kansas City
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
University of Kentucky Hospital
TERMINATED
Lexington
Louisiana
Ochsner Medical Center - Main Campus
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
UMass Memorial Medical Center
RECRUITING
Worcester
Maryland
University of Maryland Medical Center
TERMINATED
Baltimore
Michigan
Henry Ford Hospital
RECRUITING
Detroit
McLaren Flint
RECRUITING
Flint
McLaren Macomb
RECRUITING
Mount Clemens
Metro Health Hospital
RECRUITING
Wyoming
Minnesota
M Health Fairview Southdale Hospital
RECRUITING
Edina
Abbott Northwestern Hospital
RECRUITING
Minneapolis
M Health Fairview University of Minnesota Medical Center
RECRUITING
Minneapolis
Missouri
University of Missouri Health Care
RECRUITING
Columbia
Barnes Jewish Hospital
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Carolinas Medical Center
RECRUITING
Charlotte
Duke University Hospital
RECRUITING
Durham
Moses H. Cone Memorial Hospital
RECRUITING
Greensboro
ECU Health Medical Center
RECRUITING
Greenville
Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Cooper University Hospital
RECRUITING
Camden
Jersey Shore University Medical Center
RECRUITING
Neptune City
Valley Hospital
TERMINATED
Ridgewood
New Mexico
University of New Mexico Hospital
RECRUITING
Albuquerque
New York
Kings County Hospital Center
RECRUITING
Brooklyn
Maimonides Medical Center
WITHDRAWN
Brooklyn
NYU Langone Hospital - Brooklyn
RECRUITING
Brooklyn
SUNY Downstate Medical Center
RECRUITING
Brooklyn
Buffalo General Medical Center
RECRUITING
Buffalo
North Shore University Hospital
RECRUITING
Lake Success
NYP Columbia University Medical Center
RECRUITING
New York
NYP Weill Cornell Medical Center
RECRUITING
New York
NYU Langone Medical Center - Tisch Hospital
WITHDRAWN
New York
The Mount Sinai Hospital
RECRUITING
New York
Strong Memorial Hospital
ACTIVE_NOT_RECRUITING
Rochester
Montefiore Medical Center
TERMINATED
The Bronx
Ohio
Cleveland Clinic Akron General
RECRUITING
Akron
Good Samaritan Hospital
RECRUITING
Cincinnati
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
UH Cleveland Medical Center
RECRUITING
Cleveland
OSU Wexner Medical Center
RECRUITING
Columbus
Mercy St. Vincent Medical Center
RECRUITING
Toledo
Toledo Hospital
RECRUITING
Toledo
Oklahoma
OU Medical Center
RECRUITING
Oklahoma City
Oregon
Oregon Health & Science University Hospital
TERMINATED
Portland
Providence St. Vincent Medical Center
TERMINATED
Portland
Pennsylvania
Jefferson Abington Hospital
RECRUITING
Abington
UPMC Altoona
TERMINATED
Altoona
UPMC Hamot
RECRUITING
Erie
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Temple University Hospital, Philadelphia
RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
UPMC Presbyterian Hospital
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina University Hospital
RECRUITING
Charleston
Prisma Health Richland Hospital
RECRUITING
Columbia
Prisma Health Greenville Memorial Hospital
RECRUITING
Greenville
Tennessee
Methodist University Hospital
RECRUITING
Memphis
Texas
University of Texas Medical Branch
RECRUITING
Galveston
Houston Methodist Hospital
RECRUITING
Houston
Memorial Hermann Texas Medical Center
RECRUITING
Houston
Covenant Medical Center
RECRUITING
Lubbock
Medical City Plano
RECRUITING
Plano
University of Texas Health Science Center San Antonio
RECRUITING
San Antonio
UT Health Tyler
RECRUITING
Tyler
Utah
University of Utah Healthcare
WITHDRAWN
Salt Lake City
Virginia
UVA Medical Center
RECRUITING
Charlottesville
Inova Fairfax Hospital
RECRUITING
Falls Church
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
Vermont
The University of Vermont Medical Center
TERMINATED
Burlington
Washington
Harborview Medical Center
TERMINATED
Seattle
Swedish Medical Center - Cherry Hill Campus
RECRUITING
Seattle
Wisconsin
University of Wisconsin University Hospital
TERMINATED
Madison
Froedtert Hospital
WITHDRAWN
Milwaukee
West Virginia
WVU Healthcare Ruby Memorial Hospital
WITHDRAWN
Morgantown
Other Locations
Canada
Hamilton General Hospital
WITHDRAWN
Hamilton
Contact Information
Primary
Stephanie McLaren
CAPTIVA-Study@ufl.edu
888-351-7776
Backup
Neringa May
CAPTIVA-Study@ufl.edu
888-351-7776
Time Frame
Start Date: 2022-08-02
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 1683
Treatments
Experimental: Experimental Arm: Ticagrelor and Aspirin
Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Active_comparator: Standard of Care Arm: Clopidogrel and Aspirin
Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)
Experimental: Experimental Arm: Rivaroxaban and Aspirin
Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, Janssen Scientific Affairs, LLC, AstraZeneca, University of Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: University of Florida

This content was sourced from clinicaltrials.gov