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

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.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Paris, 75877, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Acronym: LA BICHAT

Important dates

Study start: 2003
Study completion: 2006
First posted: Sep 13, 2005
Registry last updated: Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed