LA BICHAT: Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00163150
Collaborator
(none)
128
1
32.1
4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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.
Study Start Date
:
Jun 1, 2003
Actual Study Completion Date
:
Feb 1, 2006
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Paris, Cedex 18 | France | 75877 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00163150
Other Study ID Numbers:
- A2581063
First Posted:
Sep 13, 2005
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms: