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Tracking Information | |||||
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First Received Date † | September 9, 2005 | ||||
Last Updated Date | March 13, 2008 | ||||
Start Date † | June 2003 | ||||
Current 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. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00163150 on ClinicalTrials.gov Archive Site | ||||
Current 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. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke | ||||
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. | ||||
Brief Summary | 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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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † | Drug: Atorvastatin | ||||
Study Arms / Comparison Groups | |||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 128 | ||||
Completion Date | February 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00163150 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Pfizer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Pfizer | ||||
Verification Date | April 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |