Comparing effects of intermittent and continuous atorvastatin on cholesterol levels and immune response
Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
This study is testing whether taking atorvastatin continuously or in intervals can better lower cholesterol levels and improve immune responses in people with high cholesterol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05790499 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different atorvastatin treatment regimens on serum LDL-C levels and the trained immunity of peripheral blood mononuclear cells. Participants will receive either intermittent or continuous atorvastatin treatment, and the study aims to determine how these approaches affect cholesterol variability and related immune responses. The research is based on previous findings that suggest cholesterol variability may influence inflammation and cardiovascular risk. The goal is to provide insights that could improve treatment strategies for managing cholesterol levels and reducing cardiovascular events.
Who should consider this trial
Good fit: Ideal candidates are men and postmenopausal women aged 18 and older with elevated LDL-C levels.
Not a fit: Patients with a history of cardiovascular events or those intolerant to statins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved atorvastatin treatment strategies that better manage cholesterol variability and reduce cardiovascular risks.
How similar studies have performed: While there is existing research on statins and cholesterol management, this specific approach comparing intermittent and continuous treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.