Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama Hospital
Birmingham, Alabama 35233
Contact:
Tammy Davis
205-975-8572
trdavis@uabmc.edu

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Adam H. de Havenon, MD
203-785-4085
adam.dehavenon@yale.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.