LDL-c Level Variability and Trained Immunity

Trained Immunity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790499
• Other study ID #: Atorvastatin-007
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Trained Immunity

Intervention

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.

Locations

Country	Name	City	State
China	Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in LDL-C levels between baseline and atorvastatin treatment cycles	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
Secondary	PBMCs subgroup percentage and activation status	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
Secondary	PBMCs secreting cytokines	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
Secondary	Differences in gene expression of PBMCs	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks
Secondary	The levels of hs-CRP, IL-6, IL-18, and sVCAM-1	in the phase of atorvastatin intermittent treatment and continuous treatment	16 weeks