Cholesterol VariabilityNCT05790499
LDL-c Level Variability and Trained Immunity
A study testing Atorvastatin in people with Cholesterol Variability and Trained Immunity, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Variability, Trained Immunity
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate, understand and sign an informed consent form;
- 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;
- Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c>3.4mmol/L
Who cannot join
- Previous cardiovascular history;
- Statins should not be discontinued in high-risk groups for cardiovascular events;
- Any known organ dysfunction;
- Intolerance to statins;
- Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
- Participating in other clinical trials;
- Unable to follow the study procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: 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.
- Conditions
- Cholesterol Variability, Trained Immunity
- Being tested
- Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in LDL-C levels between baseline and atorvastatin treatment cycles
in the phase of atorvastatin intermittent treatment and continuous treatment
Measured: 16 weeks
Secondary outcomes (4)
PBMCs subgroup percentage and activation status
in the phase of atorvastatin intermittent treatment and continuous treatment
Measured: 16 weeks
PBMCs secreting cytokines
in the phase of atorvastatin intermittent treatment and continuous treatment
Measured: 16 weeks
Differences in gene expression of PBMCs
in the phase of atorvastatin intermittent treatment and continuous treatment
Measured: 16 weeks
The levels of hs-CRP, IL-6, IL-18, and sVCAM-1
in the phase of atorvastatin intermittent treatment and continuous treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start20 Mar 2023
- Primary completion6 Aug 2024
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790499
- Sponsor's protocol ID
- Atorvastatin-007
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
- ClinicalTrials.gov ID
- NCT05790499
- Acronym / sponsor ID
- Atorvastatin-007
- Conditions
- Cholesterol Variability, Trained Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily participate, understand and sign an informed consent form;
- 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;
- Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c>3.4mmol/L
Key exclusion criteria (7 listed)
- Previous cardiovascular history;
- Statins should not be discontinued in high-risk groups for cardiovascular events;
- Any known organ dysfunction;
- Intolerance to statins;
- Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinPatients 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. | Drug | Atorvastatin |
Primary outcome
Changes in LDL-C levels between baseline and atorvastatin treatment cycles
Time frame: 16 weeks
in the phase of atorvastatin intermittent treatment and continuous treatment
4 secondary outcomes
PBMCs subgroup percentage and activation status
Time frame: 16 weeks
PBMCs secreting cytokines
Time frame: 16 weeks
Differences in gene expression of PBMCs
Time frame: 16 weeks
The levels of hs-CRP, IL-6, IL-18, and sVCAM-1
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for Cholesterol Variability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Cholesterol Variability and Trained Immunity, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in LDL-C levels between baseline and atorvastatin treatment cycles (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.