The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia: a Randomized, Double-blinded, Placebo-controlled, Multi-center Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- serum triglyceride level
研究概览
简要总结
The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A （CoA） capsule, combined use with statin, in Chinese patients with moderate dyslipidemia.
详细描述
Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule combined with statin in dyslipidemia patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TG 2.3～7.0mmol/l
- •18-80 years of age
- •combined use with statins
排除标准
- •pregnancy
- •acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit
- •nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit
- •primary hypothyroidism
- •psychiatric patients
- •poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg
- •using contraceptive agent
- •using immunosuppressive drugs, prohibited medication or other non-statin lipid-lowing drugs
研究组 & 干预措施
Coenzyme A 400mg
Coenzyme A 400mg per day
干预措施: Coenzyme A (Drug)
Placebo
Capsule without coenzyme A.
干预措施: Placebo (Drug)
结局指标
主要结局
serum triglyceride level
时间窗: 8 weeks
The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.
次要结局
- serum total cholesterol level(8 weeks)
- low-density lipoprotein cholesterol level(8 weeks)
- serum high-density lipoprotein cholesterol level(8 weeks)
研究者
Jiangtao Lai
MD
Zhejiang University