Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke
NCT00163150
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Adult Trials: 18+ Years
- 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.
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke | |||
| Official Title ICMJE | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Atorvastatin | |||
| Study Arms ICMJE | Not Provided | |||
| 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. doi: 10.1161/STROKEAHA.108.540088. Epub 2009 Mar 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 128 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | February 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00163150 | |||
| Other Study ID Numbers ICMJE | A2581063 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||