How Atorvastatin Affects the Gut Flora and Metabolomics?

Atherosclerotic Cardiovascular Disease Clinical Trial

Official title:

A Clinical Observational Trail on Atorvastatin Regulates Intestinal Flora and Metabolomics.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215237
• Other study ID #: XJTU1AF2018LSK-91
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yue Wu, Professor
• Phone: 18092826334
• Email: imyuewu[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent studies suggest that gut microbiome, the microbial community in the intestine, may directly and indirectly influence the progression of atherosclerosis. The imbalance of gut microbiome may directly promote the formation of atherosclerotic plaques by promoting the inflammatory reaction and oxidative stress affecting vascular endothelial function and increasing platelet activity. Meanwhile, it can indirectly increase the risk of atherosclerosis by enhance insulin resistance, reducing the production of bile acids and raising serum LDL-C and angiotensin levels. As shown in these researches, gut microbiome, acting as a bridge between metabolism, energy and inflammatory responses, may play an important role in cardiovascular diseases, and we believe that the interaction between microbiome and host should be considered in the ASCVD study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years;

• Statin indications such as lipid metabolism disorders, diabetes, elevated CRP, atherosclerosis; stratification according to ASCVD risk; indications for statin treatment

• Not using statins and other lipid-lowering drugs for at least 6 months before enrollment;

• Agree to receive research treatment plan;

• Voluntarily sign the informed consent.

Exclusion Criteria:

• People with active gastrointestinal bleeding or have a clear history of gastrointestinal ulcers or bleeding in the past 2 years;

• Severe renal insufficiency (eGFR <30ml / min / 1.73m2);

• Active hepatitis, liver cirrhosis, or ALT increase more than 3 times;

• Those with severe hypertension (> 180 / 110mmHg) and currently have no control;

• Hemoglobin <100g / L;

• Platelet count <100 × 109 cells / L;

• Suffering from a known serious progressive disease (such as a malignant tumor) or a disease that causes the patient to fail extremely, the estimated survival time is <12 months;

• pregnant or intending to become pregnant;

• Any situation that may interfere with the research process, such as dementia, paralysis, alcoholism, etc .;

• Expected to undergo surgery within 1 year;

• Patients participating in other ongoing clinical studies.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Atorvastatin 20 Mg Oral Tablet
Atorvastatin 20mg oral once a day

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of flora		4 months