Pharmaco-metabolomic Effects of Statins: METASTATINE

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Cardiology Society
• Collaborators: Fédération francaise de cardiologie; Fondation Coeur et Recherche; ICAN Nutrition Education and Research
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

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