Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study
试验速览
- 阶段
- 4 期
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- LDL-C target achieving rate
研究概览
简要总结
This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.
详细描述
Study Objective:
- The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population;
- The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients.
Study Design: The study was an open-label, multi-center network register-based follow-up study.
The total sample size: 10000 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
- •ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
- •Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.
排除标准
- •Patients with any allergy to statins;
- •ACS patients in acute stage；
- •Patients with severe liver disease or biliary obstruction；
- •Patients taking cyclosporine；
- •Patients who have being treated with statins currently or in the past;
- •Pregnant or lactating women and those women who planning to be pregnant;
- •Immunodeficiency or Immunocompromised patients;
- •Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
- •Patients using systemic hormone drug;
- •Researchers decided that the patients who was not suitable to participate in the study.
研究组 & 干预措施
Pitavastatin treatment
The drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd..
干预措施: Pitavastatin (Drug)
Atorvastatin treatment
The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.
干预措施: Atorvastatin (Drug)
Rosuvastatin treatment
The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
LDL-C target achieving rate
时间窗: 3 months
To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate.
次要结局
- Blood lipid parameters(1 year)
- Blood glucose levels(1 year)
- Fasting blood glucose(1 year)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Through study completion, an average of 1 year)
研究者
Jinming Yu
Professor of School of Public Health, Fudan University
Fudan University