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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

March 13, 2008

Start Date ^†

June 2003

Current Primary Outcome Measures ^†

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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00163150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Cerebrovascular Accident
Hypercholesterolemia

Intervention ^†

Drug: Atorvastatin

Study Arms / Comparison Groups

Publications *

Lavallée PC, Labreuche J, Gongora-Rivera F, Jaramillo A, Brenner D, Klein IF, Touboul PJ, Vicaut E, Amarenco P; Lacunar-BICHAT Investigators. Placebo-controlled trial of high-dose atorvastatin in patients with severe cerebral small vessel disease. Stroke. 2009 May;40(5):1721-8. Epub 2009 Mar 12.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

128

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00163150

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.