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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163150
First Posted: September 13, 2005
Last Update Posted: March 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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 Hypercholesterolemia Drug: Atorvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163150


Locations
France
Pfizer Investigational Site
Paris, Cedex 18, France, 75877
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00163150     History of Changes
Other Study ID Numbers: A2581063
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: March 14, 2008
Last Verified: April 2007

Additional relevant MeSH terms:
Hypercholesterolemia
Stroke
Cerebral Small Vessel Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors