• Yongxia Wang, Xinlu Wang, Jianru Wang, Bin Li, Rui Yu, Yucai Hu, Xingyuan Li, Guangcao Peng, Mengmeng Zhang, and Mingjun Zhu.
• Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.
• Trials. 2020 Mar 20; 21 (1): 287.

BackgroundCoronary heart disease (CHD) has become a common cardiovascular disease that seriously threatens the health of people. As reperfusion in the early phase and drug therapy, especially percutaneous coronary intervention (PCI), have become widely used in the clinic, the mortality of acute myocardial infarction in the short term has been reduced significantly. In addition, in 40%-56% of patients who experience myocardial infarction, cardiac dysfunction occurs and about 25%-33% develop heart failure.MethodsThis study was designed as a multicenter, double-blind, randomized, placebo-controlled, parallel-group, superiority trial. Participants were randomly assigned in a 1:1 ratio through a centrally controlled, computer-generated, simple randomization schedule. The primary outcome was left ventricular end-diastolic volume index = left ventricular end-diastolic volume/body surface area. The combined secondary outcomes include traditional Chinese medicine syndrome score, echocardiogram results, 6-minute walk test results, Seattle Angina Questionnaire score, cardiac magnetic resonance imaging results, biological indicators, dynamic electrocardiogram results, and experiment event rate. Assessments will be performed at baseline and at 4, 8, and 12 weeks after randomization.DiscussionThis trial will demonstrate that the addition of a Tongmai Yangxin pill (TMYX) to conventional treatment will intervene in the development of cardiac remodeling and cardiac dysfunction.Trial RegistrationThis study was registered in the Chinese Clinical Trial Registry on 7 May 2019. The registration number is ChiCRT1900023023 (http://www.chictr.org.cn/showproj.aspx?proj=12370).

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