Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis- Magnetic Resonance Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
ICAS patients who have a recent stroke and was enrolled into CAPTIVA.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Other interventionAdditional MRI to the CAPTIVA study at baseline and 12 months follow-up
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: CAPTIVA-MRI Group1 intervention
Trial outcomes
Primary outcomes
1
Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke.
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
Time frame
12 monthsSponsors and contacts
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Yale University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov