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Recruiting NCT05907629

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

— Observational Stroke Intracranial Atherosclerotic Stenosis (ICAS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI.
Who it may be relevant to
Registry conditions: Stroke, Intracranial Atherosclerotic Stenosis (ICAS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 28 centers
  • University of Alabama Hospital — Birmingham
  • University of Colorado Hospital — Aurora
  • Hartford Hospital — Hartford
  • Yale New Haven Hospital — New Haven
  • MedStar Washington Hospital Center — Washington D.C.
  • Baptist Medical Center Jacksonville — Jacksonville
  • Jackson Memorial Hospital, Miami — Miami
  • Cleveland Clinic Tradition Hospital — Port Saint Lucie
  • … and 20 more centers

Publications

  • Suri MF, Johnston SC. Epidemiology of intracranial stenosis. J Neuroimaging. 2009 Oct;19 Suppl 1:11S-6S. doi: 10.1111/j.1552-6569.2009.00415.x. PMID 19807851
  • Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9. PMID 24135208
  • Arenillas JF. Intracranial atherosclerosis: current concepts. Stroke. 2011 Jan;42(1 Suppl):S20-3. doi: 10.1161/STROKEAHA.110.597278. Epub 2010 Dec 16. PMID 21164126
  • Bang OY. Intracranial atherosclerosis: current understanding and perspectives. J Stroke. 2014 Jan;16(1):27-35. doi: 10.5853/jos.2014.16.1.27. Epub 2014 Jan 31. PMID 24741562
  • Koo J. The Latest Information on Intracranial Atherosclerosis: Diagnosis and Treatment. Interv Neurol. 2015 Oct;4(1-2):48-50. doi: 10.1159/000438779. Epub 2015 Sep 18. PMID 26600797
  • Banerjee C, Chimowitz MI. Stroke Caused by Atherosclerosis of the Major Intracranial Arteries. Circ Res. 2017 Feb 3;120(3):502-513. doi: 10.1161/CIRCRESAHA.116.308441. PMID 28154100
  • Wang A, Wu L, Wang X, Zhao X, Wang C, Liu L, Zheng H, Cao Y, Wang Y, Wang Y; China National Stroke Registry investigators. Effect of recurrent stroke on poor functional outcome in transient ischemic attack or minor stroke. Int J Stroke. 2016 Oct;11(7):NP80. doi: 10.1177/1747493016641954. Epub 2016 Mar 24. No abstract available. PMID 27012273
  • Wang YL, Pan YS, Zhao XQ, Wang D, Johnston SC, Liu LP, Meng X, Wang AX, Wang CX, Wang YJ; CHANCE investigators. Recurrent stroke was associated with poor quality of life in patients with transient ischemic attack or minor stroke: finding from the CHANCE trial. CNS Neurosci Ther. 2014 Dec;20(12):1029-35. doi: 10.1111/cns.12329. Epub 2014 Oct 13. PMID 25307297

Identifiers

NCT: NCT05907629 · Pro00050939 · 1UG3NS130228-01 · 2000031893

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗