A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Condition: Dyslipidemias; Cardiovascular Diseases; Hypertriglyceridemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias; Hypertriglyceridemia
Intervention: fenofibrate
Intervention description: Fenofibrate Capsule 200mg qd orally
Intervention MeSH terms: Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Lipid Regulating Agents; Drug Therapy; cardiovascular diseases; hypertriglyceridemia; Hydroxymethylglutaryl-CoA Reductase Inhibitors; fenofibrate; Dyslipidemias; Combination

Summary:

      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.
    

Eligibility criteria:

        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