Back to resultsHow Atorvastatin Affects the Gut Flora and Metabolomics?
Primary Purpose
Atherosclerotic Cardiovascular Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atorvastatin 20 Mg Oral Tablet
Sponsored by
About this trial
This is an interventional basic science trial for Atherosclerotic Cardiovascular Disease
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.
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Atorvastatin regulates intestinal flora
Arm Description
Outcomes
Primary Outcome Measures
Number of flora
Secondary Outcome Measures
Full Information
NCT ID
NCT04215237
First Posted
December 30, 2019
Last Updated
December 30, 2019
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04215237
Brief Title
How Atorvastatin Affects the Gut Flora and Metabolomics?
Official Title
A Clinical Observational Trail on Atorvastatin Regulates Intestinal Flora and Metabolomics.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin regulates intestinal flora
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20 Mg Oral Tablet
Intervention Description
Atorvastatin 20mg oral once a day
Primary Outcome Measure Information:
Title
Number of flora
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Wu, Professor
Phone
18092826334
Email
imyuewu@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Hao
Phone
15877383294
Email
drhaoxiang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuyi Yuan, Professor
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Hao
Phone
+86 15877383294
Email
drhaoxiang@163.com
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Wu, Professor
Phone
0086-029-8532-3664
Email
imyuewu@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
How Atorvastatin Affects the Gut Flora and Metabolomics?
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