Lee Seung-Ah, Suh Jung-Won, Park Jin Joo, Yoon Chang-Hwan, Cho Young-Suk, Youn Tae-Jin, Chae In-Ho, Kim Hyo-Soo, Kim Sang-Hyun, Choi Dong-Ju
Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Contemp Clin Trials. 2015 Jul;43:20-4. doi: 10.1016/j.cct.2015.04.005. Epub 2015 Apr 16.
The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation.
METHODS/DESIGN: The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment.
The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM.
National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643).
自药物洗脱支架（DES）问世以来，经皮冠状动脉介入治疗后支架失败率有所下降。然而，尽管植入了DES，慢性肾脏病（CKD）和糖尿病（DM）仍是预后不良的有力临床预测因素。沙格雷酯是一种选择性5-羟色胺（5-HT）2a受体拮抗剂，具有抗增殖作用，可减少内膜增生和平滑肌细胞增殖，还具有强大的抗血小板作用，可抑制5-HT诱导的血小板聚集。然而，沙格雷酯在CKD或DM患者中的疗效和安全性数据有限。我们旨在确定沙格雷酯对接受DES植入治疗的CKD或DM患者是否具有有益作用。
方法/设计：SERENADE试验是一项多中心、开放标签、前瞻性随机研究，将在CKD或DM患者的首次手术后9个月，测试三联抗血小板治疗（TAT；阿司匹林、氯吡格雷和沙格雷酯）相对于传统双联抗血小板治疗（DAT；阿司匹林和氯吡格雷）在预防晚期管腔丢失方面的优越性。共有220例诊断为患有DM或CKD的冠状动脉疾病患者将在DES植入后随机分为TAT或DAT组（1:1比例）。主要终点是通过定量冠状动脉造影评估的9个月时的晚期管腔丢失。次要疗效终点是主要不良心血管事件的复合终点，包括心源性死亡、非致死性心肌梗死和靶病变血运重建。次要安全性终点是主要出血事件以及肝或肾功能损害。
SERENADE试验将为沙格雷酯辅助治疗对CKD或DM等高风险患者DES植入后的疗效提供见解。
美国国立卫生研究院临床试验注册库（ClinicalTrials.gov NCT02294643）。
