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Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke (LA BICHAT)

Primary Purpose

Cerebrovascular Accident, Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site

Outcomes

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.

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.

Full Information

First Posted
September 9, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00163150
Brief Title
Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
128 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Paris, Cedex 18
ZIP/Postal Code
75877
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19286582
Citation
Lavallee 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. doi: 10.1161/STROKEAHA.108.540088. Epub 2009 Mar 12.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581063&StudyName=Vasomotor+Reactivity+In+Cerebral+Small+Vessel+Disease+And+New+Approach+To+Treat+Lacunar+Stroke+
Description
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Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke

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