How Atorvastatin Affects the Gut Flora and Metabolomics?

NCT04215237 | Unknown

• 1 other identifier: XJTU1AF2018LSK-91
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Number of flora

  4 months

Study Arms (1)

Atorvastatin regulates intestinal flora

OTHER

Drug: Atorvastatin 20 Mg Oral Tablet

Interventions

Atorvastatin 20 Mg Oral Tablet DRUG

Atorvastatin 20mg oral once a day

Atorvastatin regulates intestinal flora

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (2)

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Atorvastatin; Tablets

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Zuyi Yuan, Professor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yue Wu, Professor

CONTACT

18092826334; imyuewu@qq.com

Xiang Hao

CONTACT

15877383294; drhaoxiang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: November 13, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)