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NCT00163150 Clinical Trial

Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke

Hypercholesterolemia Clinical Trial

— LA BICHAT  

Official title:
Lacunar-Brain Infarction Cerebral Hyperactivity And Atorvastatin Trial. A Placebo-Controlled Trial Of High-Dose Atorvastatin In Patients With Cerebral Small Vessel Disease.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00163150
Other study ID # A2581063
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2003
Est. completion date February 2006

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - clinically defined lacunar syndrome 3 months before inclusion - small deep infarct on diffusion MRI (Diffusion Weighted Imaging) - no atherothrombotic, cardio-embolic, or other rarer cause. Exclusion Criteria: - patients with past coronary event - contra-indication for assessment of vasomotor reactivity - patients being on statin therapy at the time of brain infarction - contra-indication for statin therapy - patient still under statin therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

Locations
Country Name City State
France Pfizer Investigational Site Paris, Cedex 18

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
Secondary Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on endothelium dependant and independent vasomotoricity of humeral and / or common carotid artery (according to validation study) in lacunar patients.
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