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Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke

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NCT00163150

Last updated on April 6, 2020
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Study Location
Pfizer Investigational Site
Paris, Cedex 18, , 75877 France
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cerebrovascular Accident, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00163150
Pfizer
Completed
Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke

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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
  • Cerebrovascular Accident
  • Hypercholesterolemia
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
 (submitted: September 9, 2005) 		128
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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

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