LDL-c Level Variability and Trained Immunity

NCT ID: NCT05790499

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2024-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xiang Cheng

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiang Cheng, Doctor

Role: primary

nathancx@hust.edu.cn

+8602785726011

Other Identifiers

Atorvastatin-007

Identifier Type: -

Identifier Source: org_study_id