Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00163150

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lavallée 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. Epub 2009 Mar 12.

Study ID Numbers:	A2581063
Study First Received:	September 9, 2005
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00163150 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Cerebral Infarction
Antilipemic Agents
Stroke
Vascular Diseases
Central Nervous System Diseases
Anticholesteremic Agents
Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Brain Diseases
Cerebrovascular Disorders
Hyperkinesis
Brain Ischemia
Brain Infarction
Infarction
Metabolic Disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Antilipemic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009