Status:
COMPLETED
Pharmaco-metabolomic Effects of Statins: METASTATINE
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
Fondation Coeur et Recherche
ICAN Nutrition Education and Research
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by...
Detailed Description
The aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.
Eligibility Criteria
Inclusion
- Patient with cardiovascular risk requiring statins in primary prevention
- Contraception for women of childbearing age
Exclusion
- Previous antibiotics, proton pomp inhibitors, statins or other hypolipidemic drugs intake in the previous three months
- Renal insufficiency with creatinine clearance \<40ml/min
- Contra-indication to statins
- Previously known conditions affecting muscles, or digestive system
- Requirement of statins in secondary prevention
Key Trial Info
Start Date :
June 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03837925
Start Date
June 13 2019
End Date
December 21 2022
Last Update
January 18 2023
Active Locations (2)
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1
CIC La Sapétrière
Paris, France, 75013
2
CIC HEGP
Paris, France, 75015