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Jämförelse av anti-koagulation och anti-trombocytterapi för intrakraniell vaskulär aterostenos (CAPTIVA)

5 november 2026 uppdaterad av: University of Florida

Jämförelse av anti-koagulation och anti-trombocytterapi för intrakraniell vaskulär aterostenos (CAPTIVA)

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The proposed study is relevant to public health because narrowing of brain arteries is one of the most common causes of stroke worldwide. Compelling evidence suggests novel antithrombotic medications could reduce the rate of stroke in patients with narrowed brain arteries. The proposed study will directly compare novel antithrombotic medications to standard care antiplatelet medications for preventing stroke and death from vascular causes in patients with narrowed brain arteries.

Studietyp

Interventionell

Inskrivning (Beräknad)

1683

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • University of Alabama Hospital
      • Mobile, Alabama, Förenta staterna, 36604
        • University of South Alabama University Hospital
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85013
        • St. Joseph's Hospital and Medical Center
    • California
      • Carmichael, California, Förenta staterna, 95608
        • Mercy San Juan Medical Center
      • Chula Vista, California, Förenta staterna, 91910
        • The Neuron Clinic - Chula Vista
      • Fontana, California, Förenta staterna, 92335
        • Kaiser Permanente Fontana Medical Center
      • Long Beach, California, Förenta staterna, 90806
        • Long Beach Memorial Medical Center
      • Los Alamitos, California, Förenta staterna, 90720
        • Los Alamitos Medical Center
      • Los Angeles, California, Förenta staterna, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, Förenta staterna, 90095
        • Ronald Reagan UCLA Medical Center, Los Angeles, CA
      • Orange, California, Förenta staterna, 92868
        • UC Irvine Medical Center
      • Sacramento, California, Förenta staterna, 95817
        • UC Davis Medical Center
      • Salinas, California, Förenta staterna, 93901
        • Salinas Valley Memorial Hospital
      • San Diego, California, Förenta staterna, 92103
        • UCSD Medical Center - Hillcrest Hospital
      • Torrance, California, Förenta staterna, 90503
        • Providence Little Company of Mary Medical Center Torrance
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • University of Colorado Hospital
      • Grand Junction, Colorado, Förenta staterna, 81501
        • St. Mary's Medical Center
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06102
        • Hartford Hospital
      • New Haven, Connecticut, Förenta staterna, 06520
        • Yale New Haven Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Clearwater, Florida, Förenta staterna, 33756
        • Morton Plant Hospital
      • Gainesville, Florida, Förenta staterna, 32608
        • UF Health Shands Hospital
      • Jacksonville, Florida, Förenta staterna, 32224
        • Mayo Clinic
      • Jacksonville, Florida, Förenta staterna, 32207
        • Baptist Medical Center Jacksonville
      • Miami, Florida, Förenta staterna, 33136
        • Jackson Memorial Hospital
      • Port Saint Lucie, Florida, Förenta staterna, 34987
        • Cleveland Clinic Tradition Hospital
      • Tampa, Florida, Förenta staterna, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30303
        • Grady Memorial Hospital
      • Atlanta, Georgia, Förenta staterna, 30303
        • Emory University Hospital
      • Augusta, Georgia, Förenta staterna, 30912
        • Augusta University Medical Center
    • Illinois
      • Carbondale, Illinois, Förenta staterna, 62901
        • Memorial Hospital of Carbondale
      • Chicago, Illinois, Förenta staterna, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Förenta staterna, 60612
        • University of Illinois Hospital
      • Chicago, Illinois, Förenta staterna, 60637
        • University of Chicago Medical Center
      • Evanston, Illinois, Förenta staterna, 60201
        • Evanston Hospital
      • Oak Lawn, Illinois, Förenta staterna, 60453
        • Advocate Christ Medical Center
      • Rockford, Illinois, Förenta staterna, 61114
        • Javon Bea Hospital - Riverside
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40503
        • Baptist Health Lexington
      • Lexington, Kentucky, Förenta staterna, 40536
        • University of Kentucky Hospital
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70121
        • Ochsner Medical Center - Main Campus
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Förenta staterna, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Förenta staterna, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Förenta staterna, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, Förenta staterna, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Henry Ford Hospital
      • Flint, Michigan, Förenta staterna, 48532
        • McLaren Flint
      • Mount Clemens, Michigan, Förenta staterna, 48043
        • McLaren Macomb
      • Wyoming, Michigan, Förenta staterna, 49519
        • Metro Health Hospital
    • Minnesota
      • Edina, Minnesota, Förenta staterna, 55414
        • M Health Fairview Southdale Hospital
      • Minneapolis, Minnesota, Förenta staterna, 55407
        • Abbott Northwestern Hospital
      • Minneapolis, Minnesota, Förenta staterna, 55415
        • M Health Fairview University of Minnesota Medical Center
    • Mississippi
      • Jackson, Mississippi, Förenta staterna, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Förenta staterna, 65212
        • University of Missouri Health Care
      • St Louis, Missouri, Förenta staterna, 62269
        • Barnes Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Camden, New Jersey, Förenta staterna, 08103
        • Cooper University Hospital
      • Neptune City, New Jersey, Förenta staterna, 07753
        • Jersey Shore University Medical Center
      • Ridgewood, New Jersey, Förenta staterna, 07450
        • Valley Hospital
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87106
        • University of New Mexico Hospital
    • New York
      • Brooklyn, New York, Förenta staterna, 11203
        • SUNY Downstate Medical Center
      • Brooklyn, New York, Förenta staterna, 11203
        • Kings County Hospital Center
      • Brooklyn, New York, Förenta staterna, 11220
        • NYU Langone Hospital - Brooklyn
      • Buffalo, New York, Förenta staterna, 14202
        • Buffalo General Medical Center
      • Lake Success, New York, Förenta staterna, 11042
        • North Shore University Hospital
      • New York, New York, Förenta staterna, 10029
        • The Mount Sinai Hospital
      • New York, New York, Förenta staterna, 10021
        • NYP Weill Cornell Medical Center
      • New York, New York, Förenta staterna, 10032
        • NYP Columbia University Medical Center
      • Rochester, New York, Förenta staterna, 14642
        • Strong Memorial Hospital
      • The Bronx, New York, Förenta staterna, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28207
        • Carolinas Medical Center
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke University Hospital
      • Greensboro, North Carolina, Förenta staterna, 27405
        • Moses H. Cone Memorial Hospital
      • Greenville, North Carolina, Förenta staterna, 27834
        • ECU Health Medical Center
      • Winston-Salem, North Carolina, Förenta staterna, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Akron, Ohio, Förenta staterna, 44307
        • Cleveland Clinic Akron General
      • Cincinnati, Ohio, Förenta staterna, 45267
        • University of Cincinnati Medical Center
      • Cincinnati, Ohio, Förenta staterna, 45220
        • Good Samaritan Hospital
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Förenta staterna, 44106
        • UH Cleveland Medical Center
      • Columbus, Ohio, Förenta staterna, 43210
        • OSU Wexner Medical Center
      • Toledo, Ohio, Förenta staterna, 43608
        • Mercy St. Vincent Medical Center
      • Toledo, Ohio, Förenta staterna, 43606
        • Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • OU Medical Center
    • Oregon
      • Portland, Oregon, Förenta staterna, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Förenta staterna, 97239
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Abington, Pennsylvania, Förenta staterna, 19001
        • Jefferson Abington Hospital
      • Altoona, Pennsylvania, Förenta staterna, 16601
        • UPMC Altoona
      • Erie, Pennsylvania, Förenta staterna, 16550
        • UPMC Hamot
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
        • Temple University Hospital, Philadelphia
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • UPMC Presbyterian Hospital
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Medical University of South Carolina University Hospital
      • Columbia, South Carolina, Förenta staterna, 29203
        • Prisma Health Richland Hospital
      • Greenville, South Carolina, Förenta staterna, 29605
        • Prisma Health Greenville Memorial Hospital
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38104
        • Methodist University Hospital
    • Texas
      • Galveston, Texas, Förenta staterna, 77555
        • University of Texas Medical Branch
      • Houston, Texas, Förenta staterna, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Förenta staterna, 77030
        • Memorial Hermann Texas Medical Center
      • Lubbock, Texas, Förenta staterna, 79410
        • Covenant Medical Center
      • Plano, Texas, Förenta staterna, 75075
        • Medical City Plano
      • San Antonio, Texas, Förenta staterna, 78229
        • University of Texas Health Science Center San Antonio
      • Tyler, Texas, Förenta staterna, 75708
        • UT Health Tyler
    • Vermont
      • Burlington, Vermont, Förenta staterna, 05401
        • The University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22903
        • UVA Medical Center
      • Falls Church, Virginia, Förenta staterna, 22042
        • Inova Fairfax Hospital
      • Roanoke, Virginia, Förenta staterna, 24011
        • Carilion Roanoke Memorial Hospital
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Harborview Medical Center
      • Seattle, Washington, Förenta staterna, 98122
        • Swedish Medical Center - Cherry Hill Campus
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53792
        • University of Wisconsin University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Experimental Arm: Ticagrelor and Aspirin

Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Läkemedel: Ticagrelor + Aspirin

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

Andra namn:
  • Brilinta
Övrig: Risk Factor Management

Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
Aktiv komparator: Standard of Care Arm: Clopidogrel and Aspirin

Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)
Övrig: Risk Factor Management

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

Läkemedel: Clopidogrel + Aspirin

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

Andra namn:
  • Plavix
Experimentell: Experimental Arm: Rivaroxaban and Aspirin

Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Övrig: Risk Factor Management

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

Läkemedel: Rivaroxaban + Aspirin

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

Andra namn:
  • Xarelto

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants with parenchymal ICH or non-ICH major hemorrhage
Tidsram: Up to 12 months

Non-ICH major hemorrhage is derived from the International Society on Thrombosis and Haemostasis (ISTH) criteria consisting of any of the following:

  • Fatal bleeding
  • Symptomatic bleeding in a critical area or organ, such as subarachnoid, intraventricular, subdural, epidural, spinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome
  • Symptomatic bleeding causing a fall in hemoglobin level of 1.24 mmol/L (20g/L or greater) or more, or leading to transfusion of two units or more of whole blood or red cells
Up to 12 months
Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death
Tidsram: Up to 12 months

The definition of ischemic stroke is the American Heart Association definition that includes acute focal signs or symptoms of cerebral, spinal cord, or retinal involvement 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.
Up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Florida

Samarbetspartners

Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
AstraZeneca
Janssen Scientific Affairs, LLC
University of Cincinnati

Utredare

  • Huvudutredare: Brian L. Hoh, MD, MBA, University of Florida
  • Huvudutredare: Marc I. Chimowitz, MBChB, Medical University of South Carolina

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 augusti 2022

Primärt slutförande (Beräknad)

31 januari 2027

Avslutad studie (Beräknad)

31 januari 2027

Studieregistreringsdatum

Först inskickad

7 september 2021

Först inskickad som uppfyllde QC-kriterierna

7 september 2021

Första postat (Faktisk)

17 september 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CED000000522
  • AWD10099 (Annan identifierare: UFIRST)
  • U01NS117450 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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