Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 主要终点
- Change from baseline in telomere length after different dose statin treatment
研究概览
简要总结
Coronary heart disease (CHD) is one of the diseases characterised by biological aging as one of the important risk factors in several epidemiological studies. The mean telomere length and telomerase activity serve as markers for the biological age at the cellular level, with shorter telomeres and lower telomerase activity defining the increased biological age. Telomere length and telomerase activity, therefore, correlates with the risk of CHD and atherosclerosis. A present study states that the treatment with a statin is associated with a reduction in the number of clinical events but only in individuals with increased risk based on their telomere length. This suggests a positive relationship of telomere and telomerase system with the treatment with statins in CHD patients.
详细描述
Coronary heart disease (CHD) is identified as one of the diseases characterised by biological aging as one of the important risk factors in several epidemiological studies. Premature biological aging is distinct from chronological aging and may predispose the individual to myocardial infarction, atherosclerosis and CHD in particular. The mean telomere length and telomerase activity serve as markers for the biological age at the cellular level, with shorter telomeres and lower telomerase activity defining the increased biological age. Telomere length and telomerase activity, therefore, correlates with the risk of CHD and atherosclerosis. Statins serve as the drugs of obvious choice based on their well established efficacy and safety profiles for the treatment of CHD and associated atherosclerosis. A present clinical study states that the treatment with a statin is associated with a reduction in the number of clinical events but only in individuals with increased risk based on their telomere length. This suggests a positive relationship of telomere and telomerase system with the risk of CHD and, therefore, would help clinicians to categorise the patient populations based on their leucocyte telomere length for treatment with statins.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with ACS, planing for PCI treatment
- •Male or females who are 18-80years of age
- •No current or previous statin therapy
- •No current indication for statin therapy (Coronary artery disease; hypercholesterolemia, renal dysfunction)
- •Subjects who have given their signed consent to participate in the study
排除标准
- •Patient < 18 or > 80 years
- •Renal dysfunction
- •Hyperlipidemia
- •Active myositis
- •All forms of liver disease
- •Pregnancy
- •Breastfeeding
- •Patients being treated with other type statin
研究组 & 干预措施
randomised to rosuvastatin (20mg/d)
randomised to rosuvastatin (20mg/d)
干预措施: rosuvastatin (Drug)
randomised to rosuvastatin (10mg/d)
randomised to rosuvastatin (10mg/d)
干预措施: rosuvastatin (Drug)
结局指标
主要结局
Change from baseline in telomere length after different dose statin treatment
时间窗: baseline; 4 and 24 weeks
telomere length of circulating leukocyte will be measured by Southern blot test before and after treatment
次要结局
- PCI-related myocardial infarction (MI)(PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure)
- Change from baseline in telomerase activity after different dose statin treatment(baseline; 4 and 24 weeks)
研究者
Xiao-dong Zhuang
director of the department of cardiology
Sun Yat-sen University
