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Pharmaco-metabolomic Effects of Statins: METASTATINE

NCT03837925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-01-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Atorvastatin 40mg Tablet

Patient participation for 6 weeks of treatment

DRUG

Placebo comparator

Patient participation for 6 weeks of treatment

Sponsors & Collaborators

  • Fondation Coeur et Recherche

    collaborator UNKNOWN

  • ICAN Nutrition Education and Research

    collaborator INDUSTRY

  • Fédération francaise de cardiologie

    collaborator UNKNOWN

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Joe Elie SALEM, MD · CIC 1421 CHU Pitie Salpetriere

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2022-12-21
Completion
2022-12-21

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837925 on ClinicalTrials.gov