Clinical trial NCT04215237: How Atorvastatin Affects the Gut Flora and Metabolomics?
Official title: A Clinical Observational Trail on Atorvastatin Regulates Intestinal Flora and Metabolomics.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerotic Cardiovascular Disease
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of flora
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zuyi Yuan, Professor
role: STUDY_CHAIR
References: