A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

Study Overview
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Brief Summary
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Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.

Detailed Description
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It is an open-label , single group, multi-center study. At around 30 investigate sites, 500 dyslipidemic Chinese patients with coronary heart disease (CHD) or CHD risk equivalent, whose TG ≥1.70 mmol/L (150mg/dl) and <5.65mmol/L (500mg/dl) after at least 2 month statin monotherapy with standard dose will be enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG will be recruited and given statin-fenofibrate combination therapy for 8 weeks. Several lipid parameters and safety parameters will be compared between baseline, after 4 weeks treatment and after 8 weeks treatment. Primary efficacy endpoint is the percentage of TG decrease before and after 8 weeks treatment. Secondary endpoints on efficacy are the absolute change and the percent of change on TC, LDL-C, HDL-C, apoA1, apoB and apoB/apoA1 of baseline, after 4 weeks treatment and 8 weeks treatment, absolute change and percentage of change of hsCRP from baseline to 8 weeks of treatment. Second endpoints on safety is the incidence of AE/SAE, change on CK, ALT, AST, BUN and Cr before and after treatment and the number of clinical meaningful abnormal change defined as ALT or AST >3ULN, or CK >10ULN, or BUN >1.5ULN or Cr >1.5ULN. Other Arm type is a self comparator

Official Title
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An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients

Conditions
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Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia

Intervention / Treatment
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* Drug: fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years and < 80 years, male or female With at least one risk of coronary heart disease (CHD) [medical history of myocardial infarction (MI) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (PCI) or post coronary artery bypass grafting (CABG)] or CHD risk equivalents, which comprise, Other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease) Type 2 Diabetes Multiple risk factors that confer a 10-year risk for CHD >20%. ≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl) Subject must be able to provide informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), on his or her own behalf, prior to any study-specific procedures. Exclusion Criteria: Hypersensitive to fenofibrate or to any of its excipients Hepatic insufficiency [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2ULN (upper limit of normal)] Renal insufficiency [Creatinine clearance rate (Ccr)<60ml/min estimated from Cockcroft-Gault equation Ccr=(140-age)*weight(Kg)*0.85(if female)/[0.818*Cr (µmol/L)] Creatine kinase (CK) > 2 ULN Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency Hypothyroidism Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months Combination use of drug with similar structure as Fenofibrate, especially ketoprofen Combination use of oral anticoagulants Pregnant or lactating woman Other conditions at investigator's discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fenofibrate arm<br> | Drug: fenofibrate<br>* Fenofibrate Capsule 200mg qd orally<br>* Other names: lipanthyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Triglyceride (TG) Change | Blood tests | Baseline and up to 8 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Total Cholesterol | Blood tests | Baseline and up to 8 weeks after intervention | 
| Change in Serum Low-density Lipoprotein Cholesterol | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum High-density Lipoprotein Cholesterol | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Non-high-density Lipoprotein Cholesterol | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Apolipoprotein A1 | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Apolipoprotein B | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Alanine Aminotransferase | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Aspartate Aminotransferase | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Creatine Kinase | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum Creatinine | Blood tests | Baseline up to 8 weeks after intervention | 
| Change in Serum High Sensitivity C-reactive Protein | Blood tests | Baseline and up to 8 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combination, Lipid Regulating Agents, Drug Therapy, cardiovascular diseases, hypertriglyceridemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fenofibrate, Dyslipidemias