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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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.

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

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

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

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders

Hyperkinesis
Brain Ischemia
Brain Infarction
Metabolic disorder
Infarction
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Nervous System Diseases

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009