Abstract
IntroductionUnstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China’s medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP.Methods and analysisThis is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization.DiscussionThis trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP.Trial registrationClinicalTrials.govNCT04661709. Registered on 30 November 2020
Highlights
Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI)
Based on years of clinical experience and previous researches, we identified that Yang deficiency and blood stasis syndrome is the main pathogenesis of UAP
Syndrome differentiation and treatment is a central focus of traditional Chinese medicine (TCM)
Summary
Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. Professor Li Jun has used Wen Xin decoction for the treatment of UAP with Yang deficiency and blood stasis syndrome in the clinic for about 20 years. Due to the small sample size and the relatively short follow-up period, the curative effect of Wen Xin decoction still needs to be verified by large-scale clinical trials This multi-center, double-blind, randomized, placebocontrolled trial aims to evaluate the efficacy and safety of Wen Xin granules in patients with UAP
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