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ACTIVE NOT RECRUITING

NCT05047172

PHASE3

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

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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)

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1683

Start Date

2022-08-02

Completion Date

2028-05-31

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Intracranial Arteriosclerosis Stroke

Interventions

DRUG

Ticagrelor + Aspirin

ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)

DRUG

Rivaroxaban + Aspirin

low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)

DRUG

Clopidogrel + Aspirin

clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)

OTHER

Risk Factor Management

Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.

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

Locations (117)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (117)