Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis- Magnetic Resonance Imaging (CAPTIVA-MRI)

August 26, 2025 updated by: Yale University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama Hospital
        • Principal Investigator:
          • Ekaterina Bakradze
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Yale New Haven Hospital
        • Principal Investigator:
          • James Giles
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Not yet recruiting
        • Medstar Washington Hospital Center
        • Principal Investigator:
          • Sana Somani
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32207
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Memorial Hospital, Miami
        • Principal Investigator:
          • Victor Del Brutto
        • Contact:
        • Contact:
    • Illinois
      • Carbondale, Illinois, United States, 62901
        • Not yet recruiting
        • SIH Memorial Hospital of Carbondale
        • Principal Investigator:
          • Andrea Loggini
        • Contact:
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital
        • Principal Investigator:
          • Ali Alaraj, MD
        • Contact:
          • Lucy Rosales
          • Phone Number: 312-996-2949
          • Email: luzr@uic.edu
    • Missouri
      • St Louis, Missouri, United States, 63108
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Medical Center
        • Contact:
        • Principal Investigator:
          • Amit Kandel
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospita
        • Principal Investigator:
          • Rohan Arora
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Not yet recruiting
        • Carolinas Medical Center
        • Principal Investigator:
          • Rahul Karamchandani
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • UH Cleveland Medical Center
        • Principal Investigator:
          • Sepideh Amin-Hanjani
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CAPTIVA-MRI Group
CAPTIVA patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.
Other: MRI
Additional MRI to the CAPTIVA study at baseline and 12 months follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: David Liebeskind, MD, University of California, Los Angeles
  • Principal Investigator: Sepideh Amin-Hanjani, MD, University Hospitals
  • Principal Investigator: Rano Chatterjee, MD, Washington University School of Medicine
  • Principal Investigator: Adam de Havenon, MD, MS, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00050939
  • 1UG3NS130228-01 (U.S. NIH Grant/Contract)
  • 2000031893 (Other Identifier: Advarra IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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