依格列汀治疗轻至中度钙化性主动脉瓣狭窄的疗效与安全性：EVOID-AS试验的依据与研究设计。
完整摘要 · 中文译文
严重主动脉瓣狭窄（AS）的唯一治疗方法是主动脉瓣置换术。尽管已有多项临床试验，尚无药物疗法被证明能有效预防或延缓AS进展。EVOID-AS试验旨在评估依格列汀（一种二肽基肽酶4抑制剂）在延缓轻至中度AS患者主动脉瓣钙化进展及AS血流动力学严重程度方面的疗效。该试验将在美国及加拿大40余家临床中心纳入580例轻或中度自体钙化性AS患者，按1:1随机分配接受依格列汀10 mg或安慰剂每日一次口服，持续2年。临床随访每3个月安排一次；经胸超声心动图、主动脉瓣计算机断层扫描钙化评分及实验室检测在基线、1年及2年研究访视时获取。主要终点为治疗2年时通过心脏计算机断层扫描测量的主动脉瓣钙化变化。次要终点为治疗2年内超声心动图评估的AS血流动力学严重程度进展及至主动脉瓣干预的时间。次要安全性终点包括治疗中出现的不良事件或严重不良事件的发生率及严重程度。入组于2022年6月开始，研究预计于2028年完成。EVOID-AS是一项双盲、安慰剂对照、随机药物试验，旨在改变钙化性AS的进展。该试验将有助于满足识别有效药物疗法以预防或 以延缓AS的进展。试验注册：ClinicalTrials.gov标识符：NCT05143177。
完整摘要 · 英文原文
The only treatment of severe aortic stenosis (AS) is aortic valve replacement. No medical therapy has been proven effective for preventing or delaying AS progression despite several clinical trials. The EVOID-AS trial is designed to evaluate the efficacy of evogliptin, a dipeptidyl peptidase 4 inhibitor, at retarding the progression of aortic valve calcification and AS hemodynamic severity in patients with mild to moderate AS. In this trial, 580 patients with mild or moderate native calcific AS at 40+ clinical sites across the United States and Canada will be randomized in a 1:1 allocation to receive either evogliptin 10 mg or placebo once daily orally for 2 years. Clinical follow-up visits are scheduled at 3-month intervals; transthoracic echocardiography, aortic valve computed tomography calcium score, and laboratory testing are obtained at baseline, 1-year, and 2-year study visits. The primary end point is change in aortic valve calcification as measured by cardiac computed tomography at 2 years of therapy. Secondary end points are progression of AS hemodynamic severity by echocardiography during 2 years of therapy and time to aortic valve intervention. Secondary safety end points include incidence and severity of treatment-emergent or serious adverse events. Enrollment began in June 2022, and the study is expected to be completed in 2028. EVOID-AS is a double-blind, placebo-controlled, randomized medical trial to modify the progression of calcific AS. This trial will contribute to the critical unmet clinical need of identifying an effective medical therapy to prevent or to delay the progression of AS. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05143177.