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Confronto tra terapie anticoagulanti e antipiastriniche per l'aterostenosi vascolare intracranica (CAPTIVA)

29 ottobre 2026 aggiornato da: University of Florida

Confronto tra terapie anticoagulanti e antipiastriniche per l'aterostenosi vascolare intracranica (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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1683

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

30 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental Arm: Ticagrelor and Aspirin

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

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

Altri nomi:
  • Brilinta
Altro: Risk Factor Management

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

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

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

Droga: Clopidogrel + Aspirin

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

Altri nomi:
  • Plavix
Sperimentale: Experimental Arm: Rivaroxaban and Aspirin

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

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

Droga: Rivaroxaban + Aspirin

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

Altri nomi:
  • Xarelto

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with parenchymal ICH or non-ICH major hemorrhage
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Florida

Collaboratori

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

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 agosto 2022

Completamento primario (Stimato)

31 gennaio 2027

Completamento dello studio (Stimato)

31 gennaio 2027

Date di iscrizione allo studio

Primo inviato

7 settembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2021

Primo Inserito (Effettivo)

17 settembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CED000000522
  • AWD10099 (Altro identificatore: UFIRST)
  • U01NS117450 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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