• Xiao-Dan Yang, Jia-Xi Shi, Wei-Can Liao, Jia-Yan Cui, Zheng Jin, Dong-Liang Liu, Xin-Lin Chen, Rong Li, Hui Wu, ChuanJin Luo, QingMin Chu, Rui Li, Wei Wu, and LiJin Qing.
• Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
• Medicine (Baltimore). 2022 Dec 16; 101 (50): e32311e32311.

BackgroundHeart failure (HF), manifested as a severe or end stage of various cardiac diseases, is characterized by increased incidence, mortality, re-hospitalization, and economic burden. Myocardial infarction (MI) is one of the most common and important causes of HF. Since 2005, acute MI (AMI)-associated mortality in China has been on the rise, and MI accounts for 23.1% of the causes of HF. Traditional Chinese medicine (TCM) has the unique advantages of controlling angina pectoris and HF symptoms, and improving patients' quality of life. Compound Xueshuantong Capsule (CXSTC), also named as Fufang Xueshuantong Capsule, has the effect of increasing cardiac output and protecting myocardial function. In this trial, we aim to investigate the efficacy and safety of CXSTC in the prophylactic treatment of post-infarction HF and attempt to provide a clinical evidence-based basis for the prophylactic treatment of HF after AMI using TCM.MethodsThis will be a multi-center, randomized, double-blind, placebo-parallel controlled trial. A total of 300 patients diagnosed with AMI and undergoing percutaneous coronary intervention within 12 hours of diagnosis will be randomized 1:1 into 2 groups: the control group that will be administered conventional Western medicine plus placebo and the trial group that will be administered XST along with the conventional Western medicine. The duration of treatment will be 3 months and the follow-up will be up to 6 months for both groups. The main efficacy indicator is the incidence of HF. The secondary efficacy indicators are cardiac function classification, 6-minute walk test score, TCM syndrome score, survival quality score, brain natriuretic peptide level, ultrasensitive C-reactive protein level, and cardiac ultrasound result. Data will be collected to analyze the underlying mechanisms by using IBM SPSS 23.0 software.DiscussionBy investigating the efficacy and safety of CXSTC, this study will provide a clinical evidence base for the use of TCM in the prophylactic treatment of post-infarction HF.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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