Recruiting

Anti-coagulation & Anti-Platelet

Sponsor:

Yale University

Code:

NCT05907629

Conditions

Stroke

Intracranial Atherosclerotic Stenosis (ICAS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

Brief summary:

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

Conditions

Stroke

Intracranial Atherosclerotic Stenosis (ICAS)

Study ID

NCT05907629

Start date

Jun 24, 2024

Status verified date

Jul, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

CAPTIVA-MRI Group

CAPTIVA patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.

Interventions

MRI

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

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 ]

Central Contacts and Locations

Locations

University of Alabama Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Ekaterina Bakradze

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Principal Investigator:

James Giles

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Principal Investigator:

Sana Somani

Baptist Medical Center Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Ricardo Hanel

Jackson Memorial Hospital, Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Victor Del Brutto

University of Illinois Hospital

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

Ali Alaraj, MD

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Tareq Kass-Hout

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Alyssa Hiserote

calyssa@wustl.edu

Jill Newgent

newgentj@wustl.edu

Principal Investigator:

Yan Wang, MD

Buffalo General Medical Center

Recruiting

Buffalo, New York, United States, 14203

Contacts

Annemarie Crumlish

ac35@buffalo.edu

Principal Investigator:

Amit Kandel

North Shore University Hospita

Recruiting

Manhasset, New York, United States, 11030

Contacts

Principal Investigator:

Rohan Arora

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Yasmin AZIZ

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Sepideh Amin-Hanjani

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

UVA Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

More Information

Sponsor

Yale University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • MRI
  • Stroke
  • intracranial atherosclerotic stenosis (ICAS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-16.