A Prospective Observational Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 1,000
- 试验地点
- 42
- 主要终点
- Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
研究概览
简要总结
This study is a prospective observational program within the frames of which Tricor (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure as a part of the combination therapy with statins.
详细描述
Metabolic syndrome is a cluster of interrelated risk factors that leads to metabolic dysregulation and atherosclerotic cardiovascular diseases. The increased risk of cardiovascular disease in people with metabolic syndrome has been well established by observational studies and meta-analyses.
Strategies to reduce cardiovascular disease (CVD) risk in primary and secondary prevention focus on the optimization of low-density lipoprotein-cholesterol (LDL-C) levels. As recommended in current guidelines for lowering blood cholesterol, statins in addition to lifestyle modifications remain the first-line therapy to reduce LDL-C in patients at CVD risk. However, despite optimal reduction of LDL-C with statins and, correction of other modifiable risk factors, CVD risk is not eliminated. The source of this residual risk may be due to other atherogenic lipid species such as reduced high-density lipoprotein cholesterol (HDL-C) and/or raised triglycerides (TG) which are only modestly affected by statin therapy.
The use of fibrates in the treatment of dyslipidaemia has changed significantly over recent years.
The potential of fibrate-statin combination treatment is discussed in guidelines and by the medical community. Fenofibrate treatment usually reduce TG by 40-50%, total cholesterol (TC) and LDL-C by 5-20%, as well as small dense LDL by 10-30%.
While fibrates are generally well tolerated, combination with a statin might increase the risk of side effects and potentially that of myopathy. In the ACCORD study, fenofibrate coadministered with simvastatin was neither associated with any increase in the incidence of myopathy over that observed with simvastatin monotherapy in patients with type 2 diabetes, nor pointing out any safety concerns for the coadministration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age.
- •Triglycerides level above 2,3 mmol/l.
- •Patients having been prescribed fenofibrate 145 mg for at least 6 months AND who have been taking fenofibrate 145 mg no more than 3 days at the time of enrollment into the study.
- •Patient who take statins at the time of enrollment into the study.
- •Patients who have signed the informed consent to participate in this program.
排除标准
- •Patients who took last dose within previous treatment course of fenofibrate less than 3 months ago.
- •Statin-intolerant patients.
- •Female patients during pregnancy or breastfeeding.
- •diabetes mellitus (DM) type 1
- •Participation in any other clinical or non-clinical study/program at present or within the latest 30 days.
- •Patients with any other clinical states that make him/her ineligible for the program on the study doctor's opinion based on clinical assessment.
- •Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).
- •Known gallbladder disease.
- •Severe chronic kidney disease (creatinine clearance <60 ml/min).
- •Chronic or acute pancreatitis.
- •Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
- •Hypersensitivity to the active substance(s) or to any of the excipients.
- •Allergic to peanut or arachis oil or soya lecithin or related products due to risk of hypersensitivity reactions.
研究组 & 干预措施
Fenofibrate
Adult patients with triglycerides > 2,3 mmol/l who are on statins and who are primary prescribed fenofibrate (or fenofibrate treatment break is at least 6 months) in accordance with ordinary physician practice in Russia.
干预措施: Tricor (fenofibrate), 145 mg, film-coated tablet (Drug)
结局指标
主要结局
Change of TG at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.
时间窗: 6 months
Triglycerides will be represented in mmol/L and change of TG will be displayed as mean difference of TG at Visit 3 vs. Visit 1.
次要结局
- Change of lipid profile parameters (TC, TG, HDL, non-HDL) at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.(3 months)
- Change of C-reactive protein level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1(3 months)
- Change of LDL level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1(6months)
- Change of lipid profile parameters (TC, HDL, non-HDL) at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1(6 months)
- Change of LDL level at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1.(3 months)
- Change of C-reactive protein level at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1(6 months)
- The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 3 (6 months of fenofibrate treatment) versus baseline level at Visit 1.(6 months)
- The average score on each of 8 scales of Short Form Survey Instrument (SF)-36 quality of life questionnaire at Visit 2 (3 months of fenofibrate treatment) versus baseline level at Visit 1(3 months)