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抗凝和抗血小板治疗颅内动脉粥样硬化的比较 (CAPTIVA)

2026年11月5日 更新者：University of Florida

颅内血管动脉粥样硬化 (CAPTIVA) 抗凝和抗血小板治疗的比较

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

1683

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental Arm: Ticagrelor and Aspirin

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

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

其他名称：
  • 布里林塔
其他：Risk Factor Management

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

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

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

药品：Clopidogrel + Aspirin

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

其他名称：
  • 波立维
实验性的：Experimental Arm: Rivaroxaban and Aspirin

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

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

药品：Rivaroxaban + Aspirin

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

其他名称：
  • 拜瑞妥

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of participants with parenchymal ICH or non-ICH major hemorrhage
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Florida

合作者

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

调查人员

  • 首席研究员：Brian L. Hoh, MD, MBA、University of Florida
  • 首席研究员：Marc I. Chimowitz, MBChB、Medical University of South Carolina

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年8月2日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2021年9月7日

首先提交符合 QC 标准的

2021年9月7日

首次发布 (实际的)

2021年9月17日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CED000000522
  • AWD10099 (其他标识符：UFIRST)
  • U01NS117450 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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