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

Recruiting

• Conditions: Stroke; Intracranial Atherosclerotic Stenosis (ICAS)
• Interventions: Other: MRI

• Registration Number: NCT05907629
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Study Start: 2024-06-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (13)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

SIH Memorial Hospital of Carbondale; 🇺🇸 Carbondale, Illinois, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

UH Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States

Baptist Medical Center Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Jackson Memorial Hospital, Miami; 🇺🇸 Miami, Florida, United States

University of Illinois Hospital; 🇺🇸 Chicago, Illinois, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Buffalo General Medical Center; 🇺🇸 Buffalo, New York, United States

North Shore University Hospita; 🇺🇸 Manhasset, New York, United States