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

Hyperlipoproteinemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01928342
• Other study ID #: 2012MMXX2CoA008
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 16, 2013
• Last updated: August 19, 2013
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2013
• Source: Zhejiang University
• Contact: Jiangtao Lai, MD
• Phone: 8657187236502
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemia
• Hyperlipoproteinemias

Intervention

Drug:
• Coenzyme A
Coenzyme A 400mg per day
• Placebo
Capsule without coenzyme A.

Locations

Country	Name	City	State
China	1st Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	serum total cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level	8 weeks	Yes
Secondary	low-density lipoprotein cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.	8 weeks	Yes
Secondary	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	Yes