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首页> 外文期刊>Trials >Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study
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Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study

机译：随机控制试验的设计与理由与他汀类药物加入非纤维酸盐和他汀类药物在非糖尿病中的组合治疗的有效性，联合血脂血症的非介于中介冠状动脉疾病 - Staweno研究

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Despite the chronicled success of low-density lipoprotein cholesterol (LDLc)-lowering statin therapy, substantial residual cardiovascular (CV) disease risk remains a problem worldwide, highlighting the need to for combination therapies targeting non-LDLc factors, such as with fenofibrate. The STAFENO trial is a prospective, randomized, open-label, multi-center trial to compare the effect of statin plus fenofibrate with statin alone on the reduction and stabilization of plaque in non-diabetic, combined dyslipidemia patients with non-intervened, intermediate coronary artery disease (CAD) using virtual histology-intravascular ultrasound at 12?months. A total of 106 eligible patients are planned to be randomized to receive either a combination therapy (rosuvastatin 10?mg plus fenofibrate 160?mg/day) or monotherapy (rosuvastatin 10?mg/day) for 12?months. The primary endpoint of this study is the percentage change in the necrotic core volume. Secondary endpoints include changes in tissue characteristics and 1-year major CV events, including all-cause mortality, CV mortality, nonfatal myocardial infarction, stroke, and revascularization of the intervened and non-intervened lesions. The STAFENO trial will address whether combination treatment of statin and fenofibrate has an additive beneficial effect compared to statin alone on the reduction and stabilization of plaque and CV events in non-diabetic, combined dyslipidemia patients with non-intervened intermediate CAD.
机译：尽管具有低密度脂蛋白胆固醇（LDLC）的胆固醇（LDLC）的成功，但是，仍然存在大量残留的心血管（CV）疾病风险仍然是全世界的问题，突出了靶向非LDLC因子的联合疗法的需要，例如用Fenofibrate。 STAWENO试验是一种预期的，随机的开放标签，多中心试验，用于单独将他汀类药物加入芬纤维的效果与他汀类药物的非糖尿病，联合血脂血症患者的非糖尿病，中级冠状动脉的蛋白质的减少和稳定进行比较动脉疾病（CAD）在12月12日使用虚拟组织学 - 血管内超声。计划组合106名符合条件的患者被随机接受组合治疗（Rosuvastatin 10？Mg加入芬纤维160？Mg /天）或单药治疗（Rosuvastatin 10？Mg /天）12？个月。本研究的主要终点是坏死核心体积的百分比变化。次要终点包括组织特征和1年的主要CV事件的变化，包括所有原因死亡率，CV死亡率，非缺陷病变的中风和血管内容。与他汀类药物相比，STAWENO试验将解决他汀类药物和非诺比纤维的组合治疗是否具有与他汀类药物在非糖尿病中的斑块和CV事件的减少和稳定下的非介于中间体CAD患者的斑块和CV事件的减少和稳定性。

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