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Intracranial ArteriosclerosisPhase 3CAPTIVANCT05047172

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

A Phase 3 study testing Ticagrelor + Aspirin, Rivaroxaban + Aspirin and Clopidogrel + Aspirin in people with Intracranial Arteriosclerosis and Stroke, run by University of Florida at 114 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Intracranial Arteriosclerosis, Stroke
What is being tested?
Ticagrelor + Aspirin, Rivaroxaban + Aspirin and Clopidogrel + Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,683 participants
Where
114 sitesUnited States
Study dates
2 Aug 2022to 31 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • diabetes treated with insulin for at least 15 years
  • 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
  • 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
  • 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
  • aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
  • 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)

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

114 sites in 1 country.

114 sites in 1 country

United States114 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • Emory University Hospital

    Atlanta, Georgia, 30303

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama Hospital

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Kings County Hospital Center

    Brooklyn, New York, 11203

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

  • Buffalo General Medical Center

    Buffalo, New York, 14202

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62901

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28207

  • UVA Medical Center

    Charlottesville, Virginia, 22903

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois Hospital

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Neuron Clinic - Chula Vista

    Chula Vista, California, 91910

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Hospital

    Durham, North Carolina, 27710

  • M Health Fairview Southdale Hospital

    Edina, Minnesota, 55414

  • UPMC Hamot

    Erie, Pennsylvania, 16550

  • Evanston Hospital

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • McLaren Flint

    Flint, Michigan, 48532

  • Kaiser Permanente Fontana Medical Center

    Fontana, California, 92335

  • UF Health Shands Hospital

    Gainesville, Florida, 32608

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27405

  • ECU Health Medical Center

    Greenville, North Carolina, 27834

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • North Shore University Hospital

    Lake Success, New York, 11042

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Los Alamitos Medical Center

    Los Alamitos, California, 90720

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Ronald Reagan UCLA Medical Center, Los Angeles, CA

    Los Angeles, California, 90095

  • Covenant Medical Center

    Lubbock, Texas, 79410

  • University of Wisconsin University Hospital

    Madison, Wisconsin, 53792

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55415

  • University of South Alabama University Hospital

    Mobile, Alabama, 36604

  • McLaren Macomb

    Mount Clemens, Michigan, 48043

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Ochsner Medical Center - Main Campus

    New Orleans, Louisiana, 70121

  • NYP Weill Cornell Medical Center

    New York, New York, 10021

  • The Mount Sinai Hospital

    New York, New York, 10029

  • NYP Columbia University Medical Center

    New York, New York, 10032

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • OU Medical Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UC Irvine Medical Center

    Orange, California, 92868

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital, Philadelphia

    Philadelphia, Pennsylvania, 19140

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Medical City Plano

    Plano, Texas, 75075

  • Cleveland Clinic Tradition Hospital

    Port Saint Lucie, Florida, 34987

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24011

  • Strong Memorial Hospital

    Rochester, New York, 14642

  • Javon Bea Hospital - Riverside

    Rockford, Illinois, 61114

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Salinas Valley Memorial Hospital

    Salinas, California, 93901

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California, 92103

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center - Cherry Hill Campus

    Seattle, Washington, 98122

  • Barnes Jewish Hospital

    St Louis, Missouri, 62269

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Toledo Hospital

    Toledo, Ohio, 43606

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Providence Little Company of Mary Medical Center Torrance

    Torrance, California, 90503

  • UT Health Tyler

    Tyler, Texas, 75708

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (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.

Read the detailed description

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.

Being tested
Ticagrelor + Aspirin, Rivaroxaban + Aspirin, Clopidogrel + Aspirin, Risk Factor Management
Medical subject headings
Intracranial Arteriosclerosis, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ticagrelor + AspirinDrug

    Also called Brilinta

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

  • Rivaroxaban + AspirinDrug

    Also called Xarelto

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

  • Clopidogrel + AspirinDrug

    Also called Plavix

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

  • Risk Factor ManagementOther

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

Study groups in NCT05047172
Study groupRoleWhat they receive
Experimental Arm: Ticagrelor and AspirinExperimentalTicagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Receives: Drug: Ticagrelor + Aspirin; Other: Risk Factor Management
Standard of Care Arm: Clopidogrel and AspirinActive comparatorClopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)
Receives: Drug: Clopidogrel + Aspirin; Other: Risk Factor Management
Experimental Arm: Rivaroxaban and AspirinExperimentalRivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Receives: Drug: Rivaroxaban + Aspirin; Other: Risk Factor Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with parenchymal ICH or non-ICH major hemorrhage

    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

    Measured: Up to 12 months

  2. Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death

    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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start2 Aug 2022
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,683 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047172
Sponsor's protocol ID
CED000000522
Other IDs
AWD10099, U01NS117450
Acronym
CAPTIVA
Status last verified
Oct 2026
First submitted
7 Sep 2021
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor + Aspirin, Rivaroxaban + Aspirin and Clopidogrel + Aspirin in people with Intracranial Arteriosclerosis and Stroke, run by University of Florida at 114 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with parenchymal ICH or non-ICH major hemorrhage (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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