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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: March 13, 2008
Last verified: April 2007

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.

Condition Intervention Phase
Cerebrovascular Accident
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

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.

Estimated Enrollment: 128
Study Start Date: June 2003
Study Completion Date: February 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00163150

Pfizer Investigational Site
Paris, Cedex 18, France, 75877
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00163150     History of Changes
Other Study ID Numbers: A2581063
Study First Received: September 9, 2005
Last Updated: March 13, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cerebral Infarction
Lipid Metabolism Disorders
Metabolic Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses processed this record on April 17, 2014