Clinical trial

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

Name
Atorvastatin-007
Description
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.
Trial arms
Trial start
2023-03-20
Estimated PCD
2023-12-31
Trial end
2024-01-31
Status
Recruiting
Treatment
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.
Arms:
Atorvastatin
Size
12
Primary endpoint
Changes in LDL-C levels between baseline and atorvastatin treatment cycles
16 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}
Updated at
2023-07-07

1 organization

1 drug

2 indications