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Search / Trial NCT05047172

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.

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

0 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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