Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 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
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 (Drug)
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)
研究者
Xiang Cheng
professor
Wuhan Union Hospital, China