Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Sammenligning af anti-koagulation og anti-blodpladeterapi til intrakraniel vaskulær aterostenose (CAPTIVA)

29. oktober 2026 opdateret af: University of Florida

Sammenligning af anti-koagulation og anti-blodpladeterapi til intrakraniel vaskulær aterostenose (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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1683

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Arm: Ticagrelor and Aspirin

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

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

Andre navne:
  • Brilinta

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)

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

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

Andre navne:
  • Plavix
Eksperimentel: Experimental Arm: Rivaroxaban and Aspirin

Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)

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

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

Andre navne:
  • Xarelto

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with parenchymal ICH or non-ICH major hemorrhage
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. august 2022

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

7. september 2021

Først indsendt, der opfyldte QC-kriterier

7. september 2021

Først opslået (Faktiske)

17. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner