LDL-c Level Variability and Trained Immunity

Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity

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.

Study Overview

• Status: Recruiting
• Conditions: Trained Immunity; Cholesterol Variability
• Intervention / Treatment: Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiang Cheng, Doctor; Phone Number: +8602785726011; Email: nathancx@hust.edu.cn
      • Principal Investigator: Xiang Cheng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Voluntarily participate, understand and sign an informed consent form;
2. Age ≥ 18 years old, male or postmenopausal female (defined as amenorrhea over 2 years with relevant clinical characteristics, such as age over 55 years old or menopausal cardiovascular symptoms such as hot flashes, night sweats, palpitations, etc.). Women with hysterectomy and/or bilateral oophorectomy may also be considered for inclusion in the group;
3. Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c>3.4mmol/L

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorvastatin	Drug: Atorvastatin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in LDL-C levels between baseline and atorvastatin treatment cycles	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PBMCs subgroup percentage and activation status	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
PBMCs secreting cytokines	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
Differences in gene expression of PBMCs	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
The levels of hs-CRP, IL-6, IL-18, and sVCAM-1	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: Atorvastatin-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No