A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
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.
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
Inclusion Criteria:

 1. ≥18 years and < 80 years, male or female

 2. 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%.

 3. ≥ 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

 4. Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl)

 5. 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:

 1. Hypersensitive to fenofibrate or to any of its excipients

 2. Hepatic insufficiency [alanine aminotransferase (ALT) or aspartate aminotransferase
 (AST) > 2ULN (upper limit of normal)]

 3. 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)]

 4. Creatine kinase (CK) > 2 ULN

 5. Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase
 deficiency

 6. Hypothyroidism

 7. Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin
 and fish oil in previous 2 months

 8. Combination use of drug with similar structure as Fenofibrate, especially ketoprofen

 9. Combination use of oral anticoagulants

 10. Pregnant or lactating woman

 11. Other conditions at investigator's discretion