Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
NCT ID: NCT05047172
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1683 participants
INTERVENTIONAL
2022-08-02
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental Arm: Ticagrelor and Aspirin
Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Ticagrelor + Aspirin
ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
Standard of Care Arm: Clopidogrel and Aspirin
Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)
Clopidogrel + Aspirin
clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
Experimental Arm: Rivaroxaban and Aspirin
Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Rivaroxaban + Aspirin
low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
Interventions
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Ticagrelor + Aspirin
ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Rivaroxaban + Aspirin
low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Clopidogrel + Aspirin
clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
Risk Factor Management
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Cincinnati
OTHER
Medical University of South Carolina
OTHER
Janssen Scientific Affairs, LLC
INDUSTRY
AstraZeneca
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Brian L. Hoh, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Marc I. Chimowitz, MBChB
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
University of South Alabama University Hospital
Mobile, Alabama, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Mercy San Juan Medical Center
Carmichael, California, United States
The Neuron Clinic - Chula Vista
Chula Vista, California, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Los Alamitos Medical Center
Los Alamitos, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, CA
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
UC Davis Medical Center
Sacramento, California, United States
Salinas Valley Memorial Hospital
Salinas, California, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States
Providence Little Company of Mary Medical Center Torrance
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
St. Mary's Medical Center
Grand Junction, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Cleveland Clinic Tradition Hospital
Port Saint Lucie, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Endeavor Health Edward Hospital
Naperville, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Javon Bea Hospital - Riverside
Rockford, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
Ochsner Medical Center - Main Campus
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
McLaren Flint
Flint, Michigan, United States
McLaren Macomb
Mount Clemens, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri Health Care
Columbia, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Kings County Hospital Center
Brooklyn, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
North Shore University Hospital
Lake Success, New York, United States
NYP Weill Cornell Medical Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
NYP Columbia University Medical Center
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
ECU Health Medical Center
Greenville, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
OU Medical Center
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
UPMC Altoona
Altoona, Pennsylvania, United States
UPMC Hamot
Erie, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Methodist University Hospital
Memphis, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Covenant Medical Center
Lubbock, Texas, United States
Medical City Plano
Plano, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
UT Health Tyler
Tyler, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
UVA Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, United States
University of Wisconsin University Hospital
Madison, Wisconsin, United States
Countries
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Other Identifiers
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AWD10099
Identifier Type: OTHER
Identifier Source: secondary_id
CED000000522
Identifier Type: -
Identifier Source: org_study_id
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