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

Phase 2

• Conditions: Hyperlipoproteinemia
• Interventions: Drug: Placebo; Drug: Coenzyme A

• Registration Number: NCT01928342
• Lead Sponsor: Zhejiang University

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 Description

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.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-08
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Last Update Submitted: 2013-08-19
• Study First Posted: 2013-08-23
• Last Update Posted: 2013-08-23
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• TG 2.3～7.0mmol/l
• 18-80 years of age
• combined use with statins

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsule without coenzyme A.
Coenzyme A 400mg	Coenzyme A	Coenzyme A 400mg per day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
low-density lipoprotein cholesterol level	8 weeks	change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.
serum total cholesterol level	8 weeks	change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level
serum high-density lipoprotein cholesterol level	8 weeks	change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level.

Trial Locations

Locations (1)

1st Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China