Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
概览
- 阶段
- 不适用
- 干预措施
- Atorvastatin
- 疾病 / 适应症
- Cholesterol Variability
- 发起方
- Wuhan Union Hospital, China
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in LDL-C levels between baseline and atorvastatin treatment cycles
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
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.
研究者
Xiang Cheng
professor
Wuhan Union Hospital, China
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Atorvastatin
干预措施: Atorvastatin
结局指标
主要结局
Changes in LDL-C levels between baseline and atorvastatin treatment cycles
时间窗: 16 weeks
in the phase of atorvastatin intermittent treatment and continuous treatment
次要结局
- PBMCs secreting cytokines(16 weeks)
- The levels of hs-CRP, IL-6, IL-18, and sVCAM-1(16 weeks)
- PBMCs subgroup percentage and activation status(16 weeks)
- Differences in gene expression of PBMCs(16 weeks)