Pharmaco-metabolomic Effects of Statins: METASTATINE

French Cardiology Society

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Drug: Placebo comparator; Drug: Atorvastatin 40mg Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03837925

2016-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

ATORVASTATIN

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin 40mg Tablet

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo comparator