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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Yale University
Study ID
NCT05907629
Status
Recruiting

Conditions

  • Intracranial Atherosclerotic Stenosis (ICAS)
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI — OTHER
    Additional MRI to the CAPTIVA study at baseline and 12 months follow-up

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
Aug 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

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

Primary Outcome Measure

Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke. [ Time Frame: 12 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama HospitalBirminghamAlabama35233
Tammy Davis
205-975-8572
Ekaterina Bakradze (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06510
Michael Kampp
203-737-2073
James Giles (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Wesley Mcclure
202-877-7000
Sana Somani (PRINCIPAL_INVESTIGATOR)
Baptist Medical Center JacksonvilleJacksonvilleFlorida32207
Jefferson Atillo
Melissa Stratoberdha
Ricardo Hanel (PRINCIPAL_INVESTIGATOR)
Jackson Memorial Hospital, MiamiMiamiFlorida33136
Erick Lopez
305-243-6542
Iszet Campo-Bustillo
Victor Del Brutto (PRINCIPAL_INVESTIGATOR)
SIH Memorial Hospital of CarbondaleCarbondaleIllinois62901
Jessie Henson
618-549-0721
Andrea Loggini (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Ahmad Chahine
773-702-1848
Elida Romo
773-702-2039
Tareq Kass-Hout (PRINCIPAL_INVESTIGATOR)
University of Illinois HospitalChicagoIllinois60612
Lucy Rosales
312-996-2949
Ali Alaraj, MD (PRINCIPAL_INVESTIGATOR)
Barnes Jewish HospitalSt LouisMissouri63108
Alyssa Hiserote
Jill Newgent
Yan Wang, MD (PRINCIPAL_INVESTIGATOR)
Buffalo General Medical CenterBuffaloNew York14203
Annemarie Crumlish
Amit Kandel (PRINCIPAL_INVESTIGATOR)
North Shore University HospitaManhassetNew York11030
Ayesha Rehman
Rohan Arora (PRINCIPAL_INVESTIGATOR)
Carolinas Medical CenterCharlotteNorth Carolina28203
Anna M Swiatek
704-355-2000
Rahul Karamchandani (PRINCIPAL_INVESTIGATOR)
UH Cleveland Medical CenterClevelandOhio44106
Mary Andrew
844-828-2765
Sepideh Amin-Hanjani (PRINCIPAL_INVESTIGATOR)

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