Clinical Trial: The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Zhejiang University

Current Primary Outcome: serum triglyceride level [ Time Frame: 8 weeks ]

The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • serum total cholesterol level [ Time Frame: 8 weeks ]
    change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level
  • low-density lipoprotein cholesterol level [ Time Frame: 8 weeks ]
    change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.
  • serum high-density lipoprotein cholesterol level [ Time Frame: 8 weeks ]
    change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level.


Original Secondary Outcome: Same as current

Information By: Zhejiang University

Dates:
Date Received: August 16, 2013
Date Started: March 2012
Date Completion: October 2013
Last Updated: August 19, 2013
Last Verified: August 2013