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

Phase 4

Completed

• Conditions: Cerebrovascular Accident; Hypercholesterolemia

• Registration Number: NCT00163150
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Study Completion: 2006-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Paris, Cedex 18, France