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

Yale University

Status: Enrolling

Conditions: Stroke; Intracranial Atherosclerotic Stenosis (ICAS)

Treatments: Other: MRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05907629

Pro00050939

1UG3NS130228-01 (U.S. NIH Grant/Contract)

2000031893 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

CAPTIVA-MRI Group

Description:

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

Treatment:

Other: MRI