Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus, Hypertriglyceridemia and Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in triglycerides (TG) at week 12
研究概览
简要总结
To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.
详细描述
The primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of TG levels after 12 weeks of treatment compared to baseline.
Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 (ESC 2011) non-HDL-C target (less than 2,6 mmol/l), change of apolipoprotein B/apolipoprotein A1 (apoB/apoA1) ratio, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C) and Uric Acid (UA) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •Fasting triglycerides ≥ 1,7 mmol/l
- •Acute coronary syndrome at least before 5 and maximum 21 days before the inclusion
- •If previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion
- •In case of previous statin therapy, last LDL-C measurement before event should be ≤ 2,6 mmol/l
- •Written informed consent obtained
排除标准
- •Heart failure IV class (NYHA)
- •Acute decompensated heart failure
- •Life expectancy no more than 1 year
- •Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 Upper Limit of Normal (ULN)
- •Known gallbladder disease, including cholecystolithiasis
- •Creatinphosphokinase (CPK) > 5 ULN at baseline
- •Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
- •Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,
- •Known allergy to peanut or arachis oil or soya lecithin or related products
- •Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs
- •Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone)
- •Pregnancy and lactation
研究组 & 干预措施
Simvastatin and Fenofibrate
Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)
干预措施: Fenofibrate (Drug)
Simvastatin and Fenofibrate
Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)
干预措施: Simvastatin (Drug)
Simvastatin
Simvastatin 40 mg once daily orally for 52 weeks (1 year)
干预措施: Simvastatin (Drug)
结局指标
主要结局
Percentage change from baseline in triglycerides (TG) at week 12
时间窗: Baseline, Week 12
次要结局
- Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12(Baseline, Week 12)
- Percentage changes from baseline in uric acid at week 12(Baseline, Week 12)
- Percentage changes from baseline in apoB/apoA1 ratio at week 12(Baseline, Week 12)
- Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12(Baseline, Week 12)
- Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12(Baseline, Week 12)
- Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12(Week 12)
- Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52(Week 52)
- Percentage changes from baseline in apoB/apoA1 ratio at week 52(Baseline, Week 52)
- Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52(Baseline, Week 52)
- Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52(Baseline, Week 52)
- Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52(Baseline, Week 52)
- Percentage changes from baseline in uric acid at week 52(Baseline, Week 52)
研究者
Koval' O., MD
PhD, Professor
Dnipropetrovsk State Medical Academy