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CompletedNCT05790499Updated Sep 17, 2026

LDL-c Level Variability and Trained Immunity

An interventional study of Atorvastatin in Cholesterol Variability and Trained Immunity, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cholesterol Variability
  • Trained Immunity
03

In context

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 160 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Atorvastatin

    Drug: Atorvastatin

Interventions

  • DrugAtorvastatin

    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.

06

What researchers measure

Primary outcomes

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

    in the phase of atorvastatin intermittent treatment and continuous treatment

    Time frame: 16 weeks

Secondary outcomes

  1. PBMCs subgroup percentage and activation status

    in the phase of atorvastatin intermittent treatment and continuous treatment

    Time frame: 16 weeks

  2. PBMCs secreting cytokines

    in the phase of atorvastatin intermittent treatment and continuous treatment

    Time frame: 16 weeks

  3. Differences in gene expression of PBMCs

    in the phase of atorvastatin intermittent treatment and continuous treatment

    Time frame: 16 weeks

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

    in the phase of atorvastatin intermittent treatment and continuous treatment

    Time frame: 16 weeks

07

Study locations

1 site
  • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05790499
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Xiang Cheng (professor, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Mar 30, 2023
Start date
Mar 20, 2023
Primary completion
Aug 6, 2024
Completion
Apr 3, 2025
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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