RECRUITING

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

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Conditions

Intracranial ArteriosclerosisStroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-02
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05047172

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.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * Modified Rankin Scale score of ≤ 4, at time of consent
  4. * Ability to swallow pills
  5. * At least 30 years of age, inclusive, at time of consent
  6. * Subjects 30-49 years of age are required to meet at least ONE of the following additional criteria below to qualify for the study:
  7. 1. diabetes treated with insulin for at least 15 years
  8. 2. 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
  9. 3. 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
  10. 4. 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
  11. 5. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
  12. 6. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic
  13. * 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
  14. * Subject is willing and able to return for all follow-up evaluations required by the protocol
  15. * Subject is available by phone
  16. * Subject understands the purpose and requirements of the study and can make him/herself understood
  17. * Subject has provided informed consent (use of a LAR is not permitted)
  1. * 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
  2. * Plan to perform concomitant endarterectomy, angioplasty or stenting of an extracranial vessel tandem to the symptomatic intracranial stenosis
  3. * Intracranial tumor (except meningioma) or any intracranial vascular malformation
  4. * Thrombolytic therapy within 24 hours prior to randomization
  5. * Progressive neurological signs within 24 hours prior to randomization
  6. * History of spontaneous non-traumatic intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
  7. * 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
  8. * 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
  9. * Known allergy or contraindication to aspirin, rivaroxaban, clopidogrel, or ticagrelor
  10. * 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
  11. * 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
  12. * 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)
  13. * Dementia or psychiatric problem that prevents the subject from following an outpatient program reliably
  14. * Co-morbid conditions that may limit survival to less than 12 months
  15. * Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study, or currently breastfeeding
  16. * 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
  17. * Enrollment in another study that would conflict with the current study

Contacts and Locations

Study Contact

Stephanie McLaren
CONTACT
888-351-7776
CAPTIVA-Study@ufl.edu
Neringa May
CONTACT
888-351-7776
CAPTIVA-Study@ufl.edu

Principal Investigator

Brian L. Hoh, MD, MBA
PRINCIPAL_INVESTIGATOR
University of Florida
Marc I. Chimowitz, MBChB
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

University of Alabama Hospital
Birmingham, Alabama, 35233
United States
University of South Alabama University Hospital
Mobile, Alabama, 36604
United States
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
United States
Banner University Medical Center - Tucson Campus
Tucson, Arizona, 85724
United States
Mercy San Juan Medical Center
Carmichael, California, 95608
United States
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
United States
UCSD Health La Jolla
La Jolla, California, 92093
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Los Alamitos Medical Center
Los Alamitos, California, 90720
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Ronald Reagan UCLA Medical Center, Los Angeles, CA
Los Angeles, California, 90095
United States
UC Irvine Medical Center
Orange, California, 92868
United States
UC Davis Medical Center
Sacramento, California, 95817
United States
Salinas Valley Memorial Hospital
Salinas, California, 93901
United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103
United States
PIH Health Hospital
Whittier, California, 90602
United States
St. Mary's Medical Center
Grand Junction, Colorado, 81501
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Yale New Haven Hospital
New Haven, Connecticut, 06520
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Morton Plant Hospital
Clearwater, Florida, 33756
United States
UF Health Shands Hospital
Gainesville, Florida, 32608
United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Jackson Memorial Hospital
Miami, Florida, 33136
United States
Cleveland Clinic Tradition Hospital
Port Saint Lucie, Florida, 34987
United States
Intercoastal Medical Group - Clinical Research
Sarasota, Florida, 34239
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Emory University Hospital
Atlanta, Georgia, 30303
United States
Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
NCH Hospital
Arlington Heights, Illinois, 60005
United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62901
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois Hospital
Chicago, Illinois, 60612
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
Javon Bea Hospital - Riverside
Rockford, Illinois, 61114
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
University of Kansas Hospital
Kansas City, Kansas, 66160
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
University of Kentucky Hospital
Lexington, Kentucky, 40536
United States
Ochsner Medical Center - Main Campus
New Orleans, Louisiana, 70121
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
McLaren Flint
Flint, Michigan, 48532
United States
McLaren Macomb
Mount Clemens, Michigan, 48043
United States
Metro Health Hospital
Wyoming, Michigan, 49519
United States
M Health Fairview Southdale Hospital
Edina, Minnesota, 55414
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55415
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
University of Missouri Health Care
Columbia, Missouri, 65212
United States
Barnes Jewish Hospital
Saint Louis, Missouri, 62269
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
Valley Hospital
Ridgewood, New Jersey, 07450
United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Kings County Hospital Center
Brooklyn, New York, 11203
United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
United States
Buffalo General Medical Center
Buffalo, New York, 14202
United States
North Shore University Hospital
Lake Success, New York, 11042
United States
NYU Langone Medical Center - Tisch Hospital
New York, New York, 10016
United States
NYP Weill Cornell Medical Center
New York, New York, 10021
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
NYP Columbia University Medical Center
New York, New York, 10032
United States
Strong Memorial Hospital
Rochester, New York, 14642
United States
Carolinas Medical Center
Charlotte, North Carolina, 28207
United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27405
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OSU Wexner Medical Center
Columbus, Ohio, 43210
United States
Toledo Hospital
Toledo, Ohio, 43606
United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
United States
OU Medical Center
Oklahoma City, Oklahoma, 73104
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239
United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
United States
UPMC Altoona
Altoona, Pennsylvania, 16601
United States
UPMC Hamot
Erie, Pennsylvania, 16550
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Temple University Hospital, Philadelphia
Philadelphia, Pennsylvania, 19140
United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
United States
Methodist University Hospital
Memphis, Tennessee, 38104
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States
Covenant Medical Center
Lubbock, Texas, 79410
United States
Medical City Plano
Plano, Texas, 75075
United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
United States
UT Health Tyler
Tyler, Texas, 75708
United States
University of Utah Healthcare
Salt Lake City, Utah, 84132
United States
The University of Vermont Medical Center
Burlington, Vermont, 05401
United States
UVA Medical Center
Charlottesville, Virginia, 22903
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24011
United States
Harborview Medical Center
Seattle, Washington, 98104
United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26506
United States
University of Wisconsin University Hospital
Madison, Wisconsin, 53792
United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Brian L. Hoh, MD, MBA, PRINCIPAL_INVESTIGATOR, University of Florida
  • Marc I. Chimowitz, MBChB, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Registration Dates

Study Start Date2022-08-02
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2022-08-02
Study Completion Date2028-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Intracranial Arteriosclerosis
  • Stroke