Huanjia Gao, Hairong Cai, Jieqin Zhuang, Xingzhen Dai, Xue Fu, Weizhang Zhang, Bojun Chen
The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510006, Guangdong Province, China.
Trials. 2021 May 10;22(1):336. doi: 10.1186/s13063-021-05264-y.
Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA.
METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial.
We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA.
Chinese Clinical Trial Registry ChiCTR2100044563 . Registered on 24 March 2020.
心血管疾病是全球范围内导致死亡和发病的主要原因。慢性稳定性心绞痛（CSA）是心肌缺血的主要症状，会增加诸如心源性猝死和心肌梗死等重大心血管事件的风险。脑心通（NXT）胶囊是一种用于治疗CSA的经典中药，然而，几乎没有证据支持NXT胶囊广泛用于治疗CSA。我们设计本研究以评估NXT胶囊对比安慰剂治疗CSA患者的疗效和安全性。
方法/设计：这是一项多中心、随机、双盲、安慰剂对照的临床试验。总共将招募260名符合条件的参与者。参与者将被等比例随机分配至接受NXT或安慰剂治疗12周的组中。经过2周的导入期后，他们将接受NXT或安慰剂（每日3次，每次3粒）治疗12周。主要结局是治疗效果。次要结局指标包括中医证候量化评分、心绞痛严重程度分级、每周心绞痛发作次数、硝酸甘油用量、西雅图心绞痛量表评分、血清同型半胱氨酸以及心血管事件发生率。在整个试验过程中监测安全性结局和不良事件。
我们根据中国国家食品药品监督管理总局（CFDA）发布的原则和规定设计了本研究。研究结果将为NXT胶囊治疗CSA的疗效和安全性提供临床证据。
中国临床试验注册中心ChiCTR2100044563。于2020年3月24日注册。
