How Atorvastatin Affects the Gut Flora and Metabolomics?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Atorvastatin regulates intestinal flora

Group Type OTHER

Atorvastatin 20 Mg Oral Tablet

Intervention Type DRUG

Atorvastatin 20mg oral once a day

Interventions

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Atorvastatin 20 Mg Oral Tablet

Atorvastatin 20mg oral once a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No