Wu Xiaoping, Guo Ming, Shi Shihua, Shi Shengnan, Deng Yanping, Wang Shenglan, Wang Yabing, Wang Peili, Chen Keji
National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Department of Geriatric, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Front Cardiovasc Med. 2022 Jun 9;9:888724. doi: 10.3389/fcvm.2022.888724. eCollection 2022.
The Chinese herbal compound formula, Shenqisuxin granule (SQSX), promotes neovascularization and prevents in-stent restenosis in modern pharmaceutical studies and is expected to provide an effective strategy for non-ST-segment elevation acute coronary syndrome (NSTEACS). Thus, this study aims to examine the efficacy and safety of SQSX for NSTEACS and initially reveal its mechanism.
METHODS/DESIGN: The study is a randomized, double-blinded and placebo-controlled trial. A total of 66 participants will be randomly allocated to one of the following two groups. Participants in the SQSX group will receive conventional treatment plus SQSX, while the placebo group will receive conventional treatment plus placebo, both for 14 days. The primary outcome, hs-CRP, and secondary outcome the Seattle Angina Questionnaire (SAQ) will be assessed at baseline, 7 ± 3 days and 14 ± 3 days. At all visit windows, other indicators including creatine kinase (CK), creatine kinase-myocardial band (CK-MB), cardiac troponins I (cTnI), 12-lead electrocardiograph and the syndrome scores of Qi deficiency and blood stasis will be tested and metagenomic sequencing for intestinal flora will be performed. Echocardiography and safety assessment will be performed at baseline and 14 ± 3 days. Adverse events will be monitored during the trial.
The purpose of the study is to examine the efficacy and safety of SQSX to improve NSTEACS and initially reveal its mechanism.
China Clinical Trial Registry, ChiCTR2000029226. Registered on January 19, 2020.
中药复方制剂参芪苏心颗粒（SQSX）在现代药学研究中可促进血管新生并预防支架内再狭窄，有望为非ST段抬高型急性冠状动脉综合征（NSTEACS）提供有效策略。因此，本研究旨在探讨SQSX治疗NSTEACS的疗效和安全性，并初步揭示其作用机制。
方法/设计：本研究为随机、双盲、安慰剂对照试验。总共66名参与者将被随机分配至以下两组之一。SQSX组参与者将接受常规治疗加SQSX，而安慰剂组将接受常规治疗加安慰剂，均为期14天。主要结局指标hs-CRP和次要结局指标西雅图心绞痛问卷（SAQ）将在基线、7±3天和14±3天进行评估。在所有访视窗口，将检测包括肌酸激酶（CK）、肌酸激酶同工酶（CK-MB）、心肌肌钙蛋白I（cTnI）、12导联心电图以及气虚血瘀证候评分等其他指标，并进行肠道菌群宏基因组测序。将在基线和14±3天进行超声心动图检查和安全性评估。试验期间将监测不良事件。
本研究的目的是探讨SQSX改善NSTEACS的疗效和安全性，并初步揭示其机制。
中国临床试验注册中心，ChiCTR2000029226。于2020年1月19日注册。
