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StrokeCAPTIVA-MRINCT05907629

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

An observational study of Stroke and Intracranial Atherosclerotic Stenosis (ICAS), run by Yale University at 28 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

CAPTIVA-MRI is an observational multimodal MR imaging study that is ancillary to the CAPTIVA trial [a 3-arm, double-blind Phase III trial conducted at approximately 115 StrokeNet sites randomizing patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRI
How many people
300 participants
Where
28 sitesUnited States
Study dates
24 Jun 2024to 31 Mar 2029
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ICAS patients who have a recent stroke and was enrolled into CAPTIVA.

Who may be able to join

  • Enrollment in the CAPTIVA trial: nondisabling symptomatic ischemic infarct stroke within 30 days secondary to 70-99% stenosis of the intracranial ICA, MCA, BA or VA
  • Ability to obtain baseline study MRI within 14 days of CAPTIVA enrollmen

Who cannot join

  • Unable or unwilling to undergo MRI, including pacemaker or other MRI contraindications per American College of Radiology guidelines62
  • Gadolinium contrast allergy or acute or chronic kidney disease with eGFR<30 ml/min/1.73m2

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

28 sites in 1 country

United States28 sites, 28 recruiting
  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

    Debra HUDOCK, 330-344-6000, HudockD@ccf.org

    Not yet recruiting
  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Allison KOPP, 720-848-0000, allison.kopp@cuanschutz.edu

    Not yet recruiting
  • University of Alabama Hospital

    Birmingham, Alabama, 35233

    Tammy Davis, 205-975-8572, trdavis@uabmc.edu

    Ekaterina Bakradze

    Recruiting
  • Buffalo General Medical Center

    Buffalo, New York, 14203

    Annemarie Crumlish, ac35@buffalo.edu

    Amit Kandel

    Recruiting
  • SIH Memorial Hospital of Carbondale

    Carbondale, Illinois, 62901

    Jessie Henson, 618-549-0721, Jessie.henson@sih.net

    Andrea Loggini

    Not yet recruiting
  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

    Anna M Swiatek, 704-355-2000, Anna.M.Helms@atriumhealth.org

    Rahul Karamchandani

    Not yet recruiting
  • UVA Medical Center

    Charlottesville, Virginia, 22908

    Leo Waters, 434-924-3627, lxw3rw@uvahealth.org

    Recruiting
  • University of Illinois Hospital

    Chicago, Illinois, 60612

    Lucy Rosales, 312-996-2949, luzr@uic.edu

    Ali Alaraj, MD

    Recruiting
  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Ahmad Chahine, 773-702-1848, ahmad.chahine@bsd.uchicago.edu

    Elida Romo, 773-702-2039, eromo1@bsd.uchicago.edu

    Recruiting
  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Christina MIHOVA, 513-558-2968, mihovaca@ucmail.uc.edu

    Yasmin AZIZ

    Recruiting
  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

    Mary Andrew, 844-828-2765, mary.andrews@uhhospitals.org

    Sepideh Amin-Hanjani

    Recruiting
  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

    Georgia Taylor, 803-434-7000, georgia.taylor@prismahealth.org

    Not yet recruiting
  • Duke University Hospital

    Durham, North Carolina, 27705

    Megan GONZALEZ, 919-684-8111, megan.gonzalez@duke.edu

    Not yet recruiting
  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Stephanie ROSE, 409-772-1011, sttrose@UTMB.edu

    Recruiting
  • Hartford Hospital

    Hartford, Connecticut, 06106

    Aditya VAJJA, 860-545-5000, Aditya.Vajja@hhchealth.org

    Not yet recruiting
  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    AQUINO HERNANDEZ, 713-704-4000, Ariana.Victoria.AquinoHernandez@uth.tmc.edu

    Not yet recruiting
  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

    Jefferson Atillo, jefferson.atillo@bcmjax.com

    Melissa Stratoberdha, melissa.stratoberdha@bmcjax.com

    Recruiting
  • Covenant Medical Center

    Lubbock, Texas, 79410

    Katie HODGES, 806-725-0000, Katie.hodges@covhs.org

    Not yet recruiting
  • North Shore University Hospita

    Manhasset, New York, 11030

    Ayesha Rehman, arehman10@northwell.edu

    Rohan Arora

    Recruiting
  • Jackson Memorial Hospital, Miami

    Miami, Florida, 33136

    Erick Lopez, 305-243-6542, exl758@med.miami.edu

    Iszet Campo-Bustillo, lIcampo@med.miami.edu

    Recruiting
  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Nicole DEGERMAN, 855-324-7843, deger018@umn.edu

    Not yet recruiting
  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    Michael Kampp, 203-737-2073, michael.kampp@yale.edu

    James Giles

    Recruiting
  • NYP Columbia University Medical Center

    New York, New York, 10032

    Sandra JAVIER, 212-305-2500, smj2163@cumc.columbia.edu

    Not yet recruiting
  • Cleveland Clinic Tradition Hospital

    Port Saint Lucie, Florida, 34987

    Jessica Jordan, 772-345-8100, jordanj16@ccf.org

    Not yet recruiting
  • Barnes Jewish Hospital

    St Louis, Missouri, 63108

    Alyssa Hiserote, calyssa@wustl.edu

    Jill Newgent, newgentj@wustl.edu

    Recruiting
  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

    Dee TILLEY, 419-251-3232, Dee_Tilley@mercy.com

    Not yet recruiting
  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Wesley Mcclure, 202-877-7000, wesley.mcclure@medstar.net

    Sana Somani

    Recruiting
  • Metro Health Hospital

    Wyoming, Michigan, 49519

    Garrett hilbelink, 616-252-7200, garrett.hilbelink@umhwest.org

    Not yet recruiting

Other trials in United States

About this study

CAPTIVA-MRI is an observational multimodal MR imaging study that is ancillary to the CAPTIVA trial [a 3-arm, double-blind Phase III trial conducted at approximately 115 StrokeNet sites randomizing patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.] The primary goal of this ancillary study is to determine if MRI biomarkers can potentially identify ICAS patients who fail best medical management. The CAPTIVA-MRI study leverages the CAPTIVA trial design and implementation to capture information that will inform and facilitate the next generation of ICAS trials and the management of patients with ICAS.

Being tested
MRI
Keywords
MRI, Stroke, intracranial atherosclerotic stenosis (ICAS)
Medical subject headings
Stroke

What participants receive

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

  • MRIOther

    Additional MRI to the CAPTIVA study at baseline and 12 months follow-up

Study groups in NCT05907629
Study groupRoleWhat they receive
CAPTIVA-MRI GroupCAPTIVA patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.
Receives: Other: MRI

What is being measured

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

  1. Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke.

    Recurrent ischemic stroke, defined as symptomatic infarct in the vascular territory of the index stroke artery. This outcome is centrally adjudicated in CAPTIVA using an American Heart Association definition of ischemic stroke

    Measured: 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 posted18 Jun 2023
  2. Study start24 Jun 2024
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05907629
Sponsor's protocol ID
Pro00050939
Other IDs
1UG3NS130228-01, 2000031893
Acronym
CAPTIVA-MRI
Status last verified
Jul 2026
First submitted
7 Jun 2023
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Suri MF, Johnston SC. Epidemiology of intracranial stenosis. J Neuroimaging. 2009 Oct;19 Suppl 1:11S-6S. doi: 10.1111/j.1552-6569.2009.00415.x.

    PubMed 19807851
  • Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.

    PubMed 24135208
  • Arenillas JF. Intracranial atherosclerosis: current concepts. Stroke. 2011 Jan;42(1 Suppl):S20-3. doi: 10.1161/STROKEAHA.110.597278. Epub 2010 Dec 16.

    PubMed 21164126
  • Bang OY. Intracranial atherosclerosis: current understanding and perspectives. J Stroke. 2014 Jan;16(1):27-35. doi: 10.5853/jos.2014.16.1.27. Epub 2014 Jan 31.

    PubMed 24741562
  • Koo J. The Latest Information on Intracranial Atherosclerosis: Diagnosis and Treatment. Interv Neurol. 2015 Oct;4(1-2):48-50. doi: 10.1159/000438779. Epub 2015 Sep 18.

    PubMed 26600797
  • Banerjee C, Chimowitz MI. Stroke Caused by Atherosclerosis of the Major Intracranial Arteries. Circ Res. 2017 Feb 3;120(3):502-513. doi: 10.1161/CIRCRESAHA.116.308441.

    PubMed 28154100
  • Wang A, Wu L, Wang X, Zhao X, Wang C, Liu L, Zheng H, Cao Y, Wang Y, Wang Y; China National Stroke Registry investigators. Effect of recurrent stroke on poor functional outcome in transient ischemic attack or minor stroke. Int J Stroke. 2016 Oct;11(7):NP80. doi: 10.1177/1747493016641954. Epub 2016 Mar 24. No abstract available.

    PubMed 27012273
  • Wang YL, Pan YS, Zhao XQ, Wang D, Johnston SC, Liu LP, Meng X, Wang AX, Wang CX, Wang YJ; CHANCE investigators. Recurrent stroke was associated with poor quality of life in patients with transient ischemic attack or minor stroke: finding from the CHANCE trial. CNS Neurosci Ther. 2014 Dec;20(12):1029-35. doi: 10.1111/cns.12329. Epub 2014 Oct 13.

    PubMed 25307297
  • Albright KC, Huang L, Blackburn J, Howard G, Mullen M, Bittner V, Muntner P, Howard V. Racial differences in recurrent ischemic stroke risk and recurrent stroke case fatality. Neurology. 2018 Nov 6;91(19):e1741-e1750. doi: 10.1212/WNL.0000000000006467. Epub 2018 Oct 3.

    PubMed 30282770
  • Eriksson SE, Olsson JE. Survival and recurrent strokes in patients with different subtypes of stroke: a fourteen-year follow-up study. Cerebrovasc Dis. 2001;12(3):171-80. doi: 10.1159/000047700.

    PubMed 11641580
  • Hong KS, Yegiaian S, Lee M, Lee J, Saver JL. Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design. Circulation. 2011 May 17;123(19):2111-9. doi: 10.1161/CIRCULATIONAHA.109.934786. Epub 2011 May 2.

    PubMed 21536995
  • Chaturvedi S, Sacco RL. How recent data have impacted the treatment of internal carotid artery stenosis. J Am Coll Cardiol. 2015 Mar 24;65(11):1134-43. doi: 10.1016/j.jacc.2014.12.045.

    PubMed 25790886
  • Bonati LH, Dobson J, Featherstone RL, Ederle J, van der Worp HB, de Borst GJ, Mali WP, Beard JD, Cleveland T, Engelter ST, Lyrer PA, Ford GA, Dorman PJ, Brown MM; International Carotid Stenting Study investigators. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial. Lancet. 2015 Feb 7;385(9967):529-38. doi: 10.1016/S0140-6736(14)61184-3. Epub 2014 Oct 14.

    PubMed 25453443
  • Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, Moore WS, Hill MD, Mantese VA, Clark WM, Timaran CH, Heck D, Leimgruber PP, Sheffet AJ, Howard VJ, Chaturvedi S, Lal BK, Voeks JH, Hobson RW 2nd; CREST Investigators. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med. 2016 Mar 17;374(11):1021-31. doi: 10.1056/NEJMoa1505215. Epub 2016 Feb 18.

    PubMed 26890472
  • Paraskevas KI, Mikhailidis DP, Veith FJ, Spence JD. Definition of Best Medical Treatment in Asymptomatic and Symptomatic Carotid Artery Stenosis. Angiology. 2016 May;67(5):411-9. doi: 10.1177/0003319715624526. Epub 2015 Dec 31.

    PubMed 26721504

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Intracranial Atherosclerotic Stenosis (ICAS), run by Yale University at 28 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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.

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?

Contact Ka-Ho Wong (801-585-7575, ka-ho.wong@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke. (time frame: 12 months). 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 NCT05907629, which also lists 92 linked publications.

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 16 Jul 2026.

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