Clinical trial NCT01928342: The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hyperlipoproteinemia
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum triglyceride level
timeFrame: 8 weeks
Secondary outcomes:
measure: serum total cholesterol level
timeFrame: 8 weeks
measure: low-density lipoprotein cholesterol level
timeFrame: 8 weeks
measure: serum high-density lipoprotein cholesterol level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 1st Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Junzhu Chen
role: STUDY_CHAIR
References:
citation: 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.