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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperlipoproteinemia
• Intervention / Treatment: Drug: Coenzyme A; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jiangtao Lai, MD; Phone Number: 8657187236502

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • 1st Affiliated Hospital, College of Medicine, Zhejiang University
      • Contact: Jiangtao Lai, MD; Phone Number: 8657187236502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coenzyme A 400mg; Coenzyme A 400mg per day	Drug: Coenzyme A; Coenzyme A 400mg per day; Other Names: Coenzyme A group
PLACEBO_COMPARATOR: Placebo; Capsule without coenzyme A.	Drug: Placebo; Capsule without coenzyme A.; Other Names: Controls.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum total cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level	8 weeks
low-density lipoprotein cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.	8 weeks
serum high-density lipoprotein cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level.	8 weeks

Collaborators and Investigators

• Sponsor: Zhejiang University

Publications and helpful links

General Publications

• Lai J, Wu B, Xuan T, Liu Z, Chen J. Efficacy and tolerability of adding coenzyme A 400 U/d capsule to stable statin therapy for the treatment of patients with mixed dyslipidemia: an 8-week, multicenter, double-blind, randomized, placebo-controlled study. Lipids Health Dis. 2014 Jan 2;13:1. doi: 10.1186/1476-511X-13-1.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): October 1, 2013

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (ESTIMATE): August 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 2012MMXX2CoA008