LDL-c Level Variability and Trained Immunity

NCT05790499 | Unknown

• 1 other identifier: Atorvastatin-007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Statin treatment significantly reduces the incidence of cardiovascular events. However, cholesterol variability is associated with the risk of adverse events such as mortality, myocardial infarction, and stroke. The previous research found that the inflammatory activity of peripheral blood mononuclear cells in mice fed with intermittent high-fat diet was significantly increased, and the cholesterol variability had an impact on the trained immunity of peripheral blood mononuclear cells, thus aggravating the atherosclerosis in mice. We plan to compare the differences in serum LDL-C levels after intermittent atorvastatin treatment and continuous atorvastatin treatment, and investigate the impact of this difference on the trained immunity of peripheral blood mononuclear cells.

Conditions

Cholesterol Variability; Trained Immunity

Outcome Measures

Primary Outcomes (1)

• Changes in LDL-C levels between baseline and atorvastatin treatment cycles

  in the phase of atorvastatin intermittent treatment and continuous treatment

  16 weeks

Secondary Outcomes (4)

• PBMCs subgroup percentage and activation status

  16 weeks

• PBMCs secreting cytokines

  16 weeks

• Differences in gene expression of PBMCs

  16 weeks

• The levels of hs-CRP, IL-6, IL-18, and sVCAM-1

  16 weeks

Study Arms (1)

Atorvastatin

EXPERIMENTAL

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Patients are treated with atorvastatin for 2 weeks (40 mg/day), atorvastatin free for 2 weeks, atorvastatin treatment for 2 weeks, atorvastatin free for 2 weeks, a 4-week washout period (no treatment), and atorvastatin treatment for the last 4 weeks.

Atorvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate, understand and sign an informed consent form;
• Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c\>3.4mmol/L

You may not qualify if:

• Previous cardiovascular history;
• Statins should not be discontinued in high-risk groups for cardiovascular events;
• Any known organ dysfunction;
• Intolerance to statins;
• Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
• Participating in other clinical trials;
• Unable to follow the study procedure.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: March 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

CN (1)