Clinical trial NCT05907629: Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis- Magnetic Resonance Imaging
Official title: Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis- Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Intracranial Atherosclerotic Stenosis (ICAS)
Keywords: MRI
Stroke
intracranial atherosclerotic stenosis (ICAS)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICAS patients who have a recent stroke and was enrolled into CAPTIVA.

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.


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

Primary outcomes:
measure: Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital, Miami
state: Florida
city: Carbondale
country: United States
facility: SIH Memorial Hospital of Carbondale
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospita
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University of California, Los Angeles
name: David Liebeskind, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals
name: Sepideh Amin-Hanjani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Rano Chatterjee, MD
role: PRINCIPAL_INVESTIGATOR
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