Trial | NCT03837925  Report issue

Official Title

Pharmaco-metabolomic Effects of Statins: METASTATINE

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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 microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.
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.
Study Started
Jun 13
2019
Primary Completion
Dec 21
2022
Study Completion
Dec 21
2022
Last Update
Jan 18
2023

Drug Atorvastatin 40mg Tablet

Patient participation for 6 weeks of treatment

  • Other names: No other name

Drug Placebo comparator

Patient participation for 6 weeks of treatment

  • Other names: No other name

ATORVASTATIN Experimental

Atorvastatin 40mg caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG, to evaluate the pharmaco-metabolomic effects of the Statine

PLACEBO Placebo Comparator

Placebo caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG to compare the pharmaco-metabolomic effects of the Statine between atorvastatin arm and placebo arm

Criteria 

Inclusion Criteria:

Patient with cardiovascular risk requiring statins in primary prevention
Contraception for women of childbearing age

Exclusion Criteria:

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
No Results Posted