Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Launched by UNIVERSITY OF FLORIDA · Sep 7, 2021
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to compare different blood-thinning medications to see which is most effective in preventing strokes and other serious issues related to narrowed blood vessels in the brain. The study will test a new medication called rivaroxaban, another called ticagrelor, and a combination of both, against a standard medication known as clopidogrel. The main goal is to find out which treatment results in fewer cases of stroke, brain bleeding, or death over the course of one year.
To participate in this trial, individuals need to be at least 30 years old and have experienced certain types of stroke symptoms recently, showing evidence of narrowed arteries in the brain. Participants should be able to swallow pills and will need to provide informed consent. Throughout the study, participants will be monitored and will return for follow-up evaluations to assess their health and the effectiveness of the treatments. It’s important for potential participants to know that there are specific health conditions and treatments that could exclude them from joining the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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:
- • 1. diabetes treated with insulin for at least 15 years
- • 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
- • 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
- • 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
- • 5. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
- • 6. 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)
- 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
About University Of Florida
The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Brooklyn, New York, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Abington, Pennsylvania, United States
Providence, Rhode Island, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Boston, Massachusetts, United States
Long Beach, California, United States
Camden, New Jersey, United States
Ridgewood, New Jersey, United States
Oak Lawn, Illinois, United States
Toledo, Ohio, United States
Jackson, Mississippi, United States
Seattle, Washington, United States
Chicago, Illinois, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Brooklyn, New York, United States
Phoenix, Arizona, United States
Salinas, California, United States
Portland, Oregon, United States
Clearwater, Florida, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Omaha, Nebraska, United States
Cleveland, Ohio, United States
Hartford, Connecticut, United States
Falls Church, Virginia, United States
Wyoming, Michigan, United States
Washington, District Of Columbia, United States
Sacramento, California, United States
Galveston, Texas, United States
Baltimore, Maryland, United States
Chicago, Illinois, United States
Augusta, Georgia, United States
Columbia, South Carolina, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Winston Salem, North Carolina, United States
Rochester, New York, United States
Brooklyn, New York, United States
Worcester, Massachusetts, United States
Oklahoma City, Oklahoma, United States
Los Angeles, California, United States
Akron, Ohio, United States
Abington, Pennsylvania, United States
Kansas City, Kansas, United States
Cincinnati, Ohio, United States
Lubbock, Texas, United States
Orange, California, United States
Milwaukee, Wisconsin, United States
Lexington, Kentucky, United States
Greenville, South Carolina, United States
Atlanta, Georgia, United States
New Haven, Connecticut, United States
Memphis, Tennessee, United States
Pittsburgh, Pennsylvania, United States
Durham, North Carolina, United States
Erie, Pennsylvania, United States
Lake Success, New York, United States
Lexington, Kentucky, United States
Houston, Texas, United States
Carmichael, California, United States
Iowa City, Iowa, United States
Neptune, New Jersey, United States
New Haven, Connecticut, United States
Columbia, Missouri, United States
Charlotte, North Carolina, United States
New York, New York, United States
Burlington, Vermont, United States
Flint, Michigan, United States
Mount Clemens, Michigan, United States
Toledo, Ohio, United States
Carbondale, Illinois, United States
Charleston, South Carolina, United States
Tucson, Arizona, United States
San Diego, California, United States
Gainesville, Florida, United States
Chicago, Illinois, United States
Columbus, Ohio, United States
Jacksonville, Florida, United States
Birmingham, Alabama, United States
Portland, Oregon, United States
Albuquerque, New Mexico, United States
Salt Lake City, Utah, United States
Altoona, Pennsylvania, United States
Los Alamitos, California, United States
New York, New York, United States
Scottsdale, Arizona, United States
Grand Junction, Colorado, United States
New York, New York, United States
Cleveland, Ohio, United States
Fontana, California, United States
Morgantown, West Virginia, United States
Hamilton, Ontario, Canada
Torrance, California, United States
Madison, Wisconsin, United States
Whittier, California, United States
Mobile, Alabama, United States
Brooklyn, New York, United States
Greensboro, North Carolina, United States
Seattle, Washington, United States
Plano, Texas, United States
New Orleans, Louisiana, United States
Rockford, Illinois, United States
Buffalo, New York, United States
La Jolla, California, United States
Edina, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
Charlottesville, Virginia, United States
Los Angeles, California, United States
Philadelphia, Pennsylvania, United States
Greenville, North Carolina, United States
Port Saint Lucie, Florida, United States
Roanoke, Virginia, United States
Sarasota, Florida, United States
Minneapolis, Minnesota, United States
Tyler, Texas, United States
Arlington Heights, Illinois, United States
Chula Vista, California, United States
Patients applied
Trial Officials
Brian L. Hoh, MD, MBA
Principal Investigator
University of Florida
Marc I. Chimowitz, MBChB
Principal Investigator
Medical University of South Carolina
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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