Comparing blood-thinning therapies for patients with severe intracranial artery narrowing

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

This study is testing how well different blood-thinning medications work for stroke patients with severe narrowing of the arteries in the brain, using MRI scans to find out who might not be responding to treatment.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 13 sites (Birmingham, Alabama and 12 other locations)
• Trial ID: NCT05907629 on ClinicalTrials.gov

What this trial studies

This observational study, known as CAPTIVA-MRI, is designed to analyze MRI biomarkers in patients with severe intracranial atherosclerotic stenosis (ICAS) who have experienced a stroke. It is an ancillary study to the CAPTIVA trial, which involves randomizing patients to different blood-thinning medications. The primary aim is to identify patients who do not respond to the best medical management through advanced MRI imaging techniques. The findings are expected to inform future ICAS trials and improve patient management strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals who have experienced a nondisabling ischemic stroke due to severe intracranial artery narrowing and are enrolled in the CAPTIVA trial.

Not a fit: Patients who are unable to undergo MRI or have contraindications to MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification of patients who need alternative treatments for ICAS, potentially reducing the risk of future strokes.

How similar studies have performed: Other studies have shown promise in using MRI biomarkers for similar conditions, but this specific approach is relatively novel.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama and 12 other locations

• University of Alabama Hospital — Birmingham, Alabama, United States (Recruiting)
• Yale New Haven Hospital — New Haven, Connecticut, United States (Not_yet_recruiting)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States (Recruiting)
• Jackson Memorial Hospital, Miami — Miami, Florida, United States (Recruiting)
• SIH Memorial Hospital of Carbondale — Carbondale, Illinois, United States (Not_yet_recruiting)
• University of Illinois Hospital — Chicago, Illinois, United States (Recruiting)
• University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
• Barnes Jewish Hospital — St Louis, Missouri, United States (Recruiting)
• Buffalo General Medical Center — Buffalo, New York, United States (Recruiting)
• North Shore University Hospita — Manhasset, New York, United States (Recruiting)
• Carolinas Medical Center — Charlotte, North Carolina, United States (Not_yet_recruiting)
• UH Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: David Liebeskind, MD — University of California, Los Angeles
• Study coordinator: Ka-Ho Wong

Conditions Stroke; Intracranial Atherosclerotic Stenosis; MRI; intracranial atherosclerotic stenosis