NCT03837925

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_3 cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

February 7, 2019

Last Update Submit

January 17, 2023

Conditions

Cardiovascular Diseases

Keywords

Statinscardiovascular riskprimary prevention microbiotametabolomics

Outcome Measures

Primary Outcomes (1)

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

    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

    Week-6

Secondary Outcomes (4)

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

    week-2

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

    Week-2 and week-6

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

    Week 2 and Week 6

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

    Week 2 and Week 6

Study Arms (2)

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

Drug: Atorvastatin 40mg Tablet

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

Drug: Placebo comparator

Interventions

Atorvastatin 40mg TabletDRUG

Patient participation for 6 weeks of treatment

Also known as: No other name
ATORVASTATIN
Placebo comparatorDRUG

Patient participation for 6 weeks of treatment

Also known as: No other name
PLACEBO

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CIC La Sapétrière

Paris, 75013, France

Location

CIC HEGP

Paris, 75015, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Joe Elie SALEM, MD

    CIC 1421 CHU Pitie Salpetriere

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo manufactured as the treatment. Packaging identical.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups of patients having treatment or placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 12, 2019

Study Start

June 13, 2019

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)