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

Stroke Clinical Trial

— CAPTIVA-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907629
• Other study ID #: Pro00050939
• Secondary ID: 1UG3NS130228-012
• Status: Recruiting
• Start date: May 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Adam H. de Havenon, MD
• Phone: 203-785-4085
• Email: adam.dehavenon[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Buffalo General Medical Center	Buffalo	New York
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois Hospital	Chicago	Illinois
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	North Shore University Hospita	Manhasset	New York
United States	Jackson Memorial Hospital, Miami	Miami	Florida
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (94)

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Welker K, Boxerman J, Kalnin A, Kaufmann T, Shiroishi M, Wintermark M; American Society of Functional Neuroradiology MR Perfusion Standards and Practice Subcommittee of the ASFNR Clinical Practice Committee. ASFNR recommendations for clinical performance — View Citation

Wong KS, Li H, Chan YL, Ahuja A, Lam WW, Wong A, Kay R. Use of transcranial Doppler ultrasound to predict outcome in patients with intracranial large-artery occlusive disease. Stroke. 2000 Nov;31(11):2641-7. doi: 10.1161/01.str.31.11.2641. — View Citation

Wright CB, Bosetti F, Janis LS, Koenig JI, Moy CS. Organizational Update: NINDS Stroke Research Strategies for Large Vessel Occlusion and Neuroprotection. Stroke. 2021 Jan;52(1):e1-e2. doi: 10.1161/STROKEAHA.120.029977. Epub 2020 Dec 28. No abstract avail — View Citation

Wu J, Wang P, Zhou L, Zhang D, Chen Q, Mao C, Su W, Huo Y, Peng J, Yin X, Chen G. Hemodynamics derived from computational fluid dynamics based on magnetic resonance angiography is associated with functional outcomes in atherosclerotic middle cerebral arte — View Citation

Yoneyama Y, Isoda H, Ishiguro K, Terada M, Kamiya M, Otsubo K, Perera R, Mizuno T, Fukuyama A, Takiguchi K, Watanabe T, Kosugi T, Komori Y, Naganawa S. Evaluation of magnetic resonance angiography as a possible alternative to rotational angiography or com — View Citation

* Note: There are 94 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months