LDL-c Level Variability and Trained Immunity

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05790499
• Collaborator: (none)
• Enrollment: 12
• Arm: 1
• Anticipated Duration (Months): 10.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholesterol Variability; Trained Immunity	Drug: Atorvastatin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
• Anticipated Study Start Date: Mar 20, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in LDL-C levels between baseline and atorvastatin treatment cycles [16 weeks]

   in the phase of atorvastatin intermittent treatment and continuous treatment

Secondary Outcome Measures

1. PBMCs subgroup percentage and activation status [16 weeks]

   in the phase of atorvastatin intermittent treatment and continuous treatment

2. PBMCs secreting cytokines [16 weeks]

   in the phase of atorvastatin intermittent treatment and continuous treatment

3. Differences in gene expression of PBMCs [16 weeks]

   in the phase of atorvastatin intermittent treatment and continuous treatment

4. The levels of hs-CRP, IL-6, IL-18, and sVCAM-1 [16 weeks]

   in the phase of atorvastatin intermittent treatment and continuous treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiang Cheng, professor, Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT05790499
• Other Study ID Numbers: Atorvastatin-007
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atorvastatin

Study Results

No Results Posted as of Mar 30, 2023