Skip to main content
OpenTrials
Completed

NCT Number: NCT03837925

Pharmaco-metabolomic Effects of Statins: METASTATINE

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIC HEGP, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin 40mg Tablet

Drug

Patient participation for 6 weeks of treatment

Other names: No other name

placebo comparator

Drug

Patient participation for 6 weeks of treatment

Other names: No other name

Primary outcomes

  1. Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-6 in atorvastatin arm and placebo arm.

    Time frame: Week-6

    The main objective of the study is to measure the direct effect of Hydroxy-methyl-glutaryl-coenzyme A reductase inhibitors (Atorvastatin) on the production of atherogenic metabolites derived from intestinal microbiota

Secondary outcomes

  1. Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-2 in atorvastatin arm and placebo arm.

    Time frame: week-2

    To evaluate the evolution of the whole circulating metabolomic profile linked to the introduction of statins

  2. Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured pre and post-prandially at week-2 and week-6 in atorvastatin arm.

    Time frame: Week-2 and week-6

    To evaluate changes in the microbiome related to the introduction of statins

  3. Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of circulating metabolomic profile (pre- and postprandial)

    Time frame: Week 2 and Week 6

    To correlate changes in lipid parameters induced by statins with metabolomic and lipidemic changes and microbiome. Rate of 100 metabolites will be analysed, and gathered as follows:

    metabolism of acylcarnitine (3), metabolism of bile acids (5), carbohydrate metabolism (1), dietary choline metabolism (3), metabolism of amino acids (34), vitamins and cofactors (7), metabolism of creatine (2), polyamine metabolism (3), purine metabolism (5), pyrimidine metabolism (9), tryptophan / kynurenine metabolism (21), caffeine metabolism (3), Citric Acid cycle (3), urea cycle (1)

  4. Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of the microbiome

    Time frame: Week 2 and Week 6

    To analyze the influence of the microbiota on the variability of response to atorvastatin.

    169/5000 The stool will be analyzed by metagenomic sequencing using the "shot gun" technique, a direct sequencing that quantifies the number of bacterial genes and annotates them.

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • Fondation Coeur et Recherche
  • Fédération francaise de cardiologie
  • ICAN Nutrition Education and Research

Registry information

Acronym: METASTATINE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.