New blood thinner cocktails aim to outsmart stroke in High-Risk patients

NCT ID NCT05047172

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 26 times

Summary

This large phase 3 trial tests whether newer blood thinner combinations (ticagrelor plus aspirin or rivaroxaban plus aspirin) are better than the standard clopidogrel plus aspirin at preventing stroke, brain bleeding, or death from blood vessel disease. Over 1,600 participants with a recent stroke due to severe narrowing of a brain artery are being followed for one year. The study also manages risk factors like cholesterol and blood pressure to improve overall outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ticagrelor, rivaroxaban, clopidogrel, and aspirin
What this could lead to: If successful, this could identify a more effective daily drug combination to prevent strokes in people with narrowed brain arteries.
What could go wrong: This is a large phase 3 trial, but results are not yet available. The newer drugs may increase bleeding risk without being more effective than the standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,683 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cerebral atherosclerosis intracranial arteriosclerosis ischemic stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial arteriosclerosis Stroke

Contacts and locations

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
Baptist Health Lexington

Lexington, Kentucky, 40503, United States
Baptist Medical Center Jacksonville

Jacksonville, Florida, 32207, United States
Barnes Jewish Hospital

St Louis, Missouri, 62269, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Buffalo General Medical Center

Buffalo, New York, 14202, United States
Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24011, United States
Carolinas Medical Center

Charlotte, North Carolina, 28207, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Cleveland Clinic Akron General

Akron, Ohio, 44307, United States
Cleveland Clinic Tradition Hospital

Port Saint Lucie, Florida, 34987, United States
Cooper University Hospital

Camden, New Jersey, 08103, United States
Covenant Medical Center

Lubbock, Texas, 79410, United States
Duke University Hospital

Durham, North Carolina, 27710, United States
ECU Health Medical Center

Greenville, North Carolina, 27834, United States
Emory University Hospital

Atlanta, Georgia, 30303, United States
Evanston Hospital

Evanston, Illinois, 60201, United States
Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States
Grady Memorial Hospital

Atlanta, Georgia, 30303, United States
Harborview Medical Center

Seattle, Washington, 98104, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Jackson Memorial Hospital

Miami, Florida, 33136, United States
Javon Bea Hospital - Riverside

Rockford, Illinois, 61114, United States
Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States
Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States
Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
Kings County Hospital Center

Brooklyn, New York, 11203, United States
Long Beach Memorial Medical Center

Long Beach, California, 90806, United States
Los Alamitos Medical Center

Los Alamitos, California, 90720, United States
M Health Fairview Southdale Hospital

Edina, Minnesota, 55414, United States
M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, 55415, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
McLaren Flint

Flint, Michigan, 48532, United States
McLaren Macomb

Mount Clemens, Michigan, 48043, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical City Plano

Plano, Texas, 75075, United States
Medical University of South Carolina University Hospital

Charleston, South Carolina, 29425, United States
Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States
Memorial Hospital of Carbondale

Carbondale, Illinois, 62901, United States
Mercy San Juan Medical Center

Carmichael, California, 95608, United States
Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States
Methodist University Hospital

Memphis, Tennessee, 38104, United States
Metro Health Hospital

Wyoming, Michigan, 49519, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Morton Plant Hospital

Clearwater, Florida, 33756, United States
Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27405, United States
NYP Columbia University Medical Center

New York, New York, 10032, United States
NYP Weill Cornell Medical Center

New York, New York, 10021, United States
NYU Langone Hospital - Brooklyn

Brooklyn, New York, 11220, United States
North Shore University Hospital

Lake Success, New York, 11042, United States
OSU Wexner Medical Center

Columbus, Ohio, 43210, United States
OU Medical Center

Oklahoma City, Oklahoma, 73104, United States
Ochsner Medical Center - Main Campus

New Orleans, Louisiana, 70121, United States
Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States
Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States
Providence Little Company of Mary Medical Center Torrance

Torrance, California, 90503, United States
Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Ronald Reagan UCLA Medical Center, Los Angeles, CA

Los Angeles, California, 90095, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States
Salinas Valley Memorial Hospital

Salinas, California, 93901, United States
St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States
St. Mary's Medical Center

Grand Junction, Colorado, 81501, United States
Strong Memorial Hospital

Rochester, New York, 14642, United States
Swedish Medical Center - Cherry Hill Campus

Seattle, Washington, 98122, United States
Tampa General Hospital

Tampa, Florida, 33606, United States
Temple University Hospital, Philadelphia

Philadelphia, Pennsylvania, 19140, United States
The Mount Sinai Hospital

New York, New York, 10029, United States
The Neuron Clinic - Chula Vista

Chula Vista, California, 91910, United States
The University of Vermont Medical Center

Burlington, Vermont, 05401, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Toledo Hospital

Toledo, Ohio, 43606, United States
UC Davis Medical Center

Sacramento, California, 95817, United States
UC Irvine Medical Center

Orange, California, 92868, United States
UCSD Medical Center - Hillcrest Hospital

San Diego, California, 92103, United States
UF Health Shands Hospital

Gainesville, Florida, 32608, United States
UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States
UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States
UPMC Altoona

Altoona, Pennsylvania, 16601, United States
UPMC Hamot

Erie, Pennsylvania, 16550, United States
UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States
UT Health Tyler

Tyler, Texas, 75708, United States
UVA Medical Center

Charlottesville, Virginia, 22903, United States
University of Alabama Hospital

Birmingham, Alabama, 35233, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Illinois Hospital

Chicago, Illinois, 60612, United States
University of Kansas Hospital

Kansas City, Kansas, 66160, United States
University of Kentucky Hospital

Lexington, Kentucky, 40536, United States
University of Maryland Medical Center

Baltimore, Maryland, 21201, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Missouri Health Care

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States
University of South Alabama University Hospital

Mobile, Alabama, 36604, United States
University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States
University of Texas Medical Branch

Galveston, Texas, 77555, United States
University of Wisconsin University Hospital

Madison, Wisconsin, 53792, United States
Valley Hospital

Ridgewood, New Jersey, 07450, United States
Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States
Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

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