scholarly journals Danhong Injection Combined With Naoxintong Capsule in Patients With Acute Coronary Syndrome Patients Undergoing PCI: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
hairong cai ◽  
Luo Sicong ◽  
Gao Huanjia ◽  
Liu Shuling ◽  
Zhao Shuai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Major Adverse Cardiovascular Events ◽  
Controlled Clinical Trial ◽  
Evidence Based ◽  
Efficacy And Safety ◽  
Coronary Syndrome ◽  
Danhong Injection

Abstract Background: Acute coronary syndrome (ACS) is a group of clinical syndromes caused by thrombosis caused by rupture of coronary atherosclerotic plaque or erosion ulcer, resulting in complete or incomplete occlusion of blood vessels. ACS is the most common cardiovascular critical disease. Although with the development of coronary intervention technology, the incidence of major adverse cardiovascular events (MACE) is still high. In China, traditional Chinese medicine (TCM) has been widely used in the adjuvant treatment of ACS to improve the symptoms and prognosis. Danhong injection (DHI) and Naoxintong capsule (NXTC) may improve the prognosis of patients with ACS, but the evidence-based evidence is still insufficient. The main purpose of this study was to evaluate the efficacy and safety of DHI combined with NXTC in the treatment of ACS.Methods/design:This is a randomized, placebo-controlled clinical trial.1752 patients with ACS undergoing percutaneous coronary intervention (PCI) will be randomly assigned to receive DHI combined with NXTC or placebo at the ratio of 1:1. The course of treatment was 12 weeks. All participants received conventional treatment. The main outcome measure was the 12-months incidence of MACEs. Adverse events (AE) will also be evaluated.Discussion:This trial is a well designed study according to principles and regulations issued by the China food and Drug Administration (CFDA). The results will provide high-quality evidence for the efficacy and safety of DHI combined with NXTC in the treatment of ACS. The results of this study can provide clinicians with evidence-based recommendations for treatment of ACS.Trial registration：Chinese Clinical Trial Registry(http://www.chictr.org.cn/index.aspx), ChiCTR-IOR-14005693.Registered on November 12,2014.

scholarly journals Efficacy and safety of high-dose Xueshuantong injection (lyophilised) in reducing the incidence of major adverse cardiovascular events in patients with unstable angina: a protocol of a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial based on dual antiplatelet therapy

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038074
Author(s):  
Wenjie Long ◽  
Huili Liao ◽  
Xi Huang ◽  
Qingqing Liu ◽  
Yaqing Tang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Unstable Angina ◽  
Cardiovascular Events ◽  
Major Adverse Cardiovascular Events ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Multicentre Clinical Trial ◽  
Coronary Syndrome ◽  
Link Type

IntroductionUnstable angina (UA), referred to as acute coronary syndrome (ACS), causes unexpected chest pain. Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS. However, no clinical trial has been performed in this field. This clinical trial aims to examine the efficacy and safety of XST.Methods and analysisThis is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. A total of 1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group. The efficacy assessment and major adverse cardiovascular events will be observed, and the frequency of angina attack, angina pectoris will be examined at the start and end of the run-in period. All adverse events will be recorded, regardless of the severity, to assess the safety of XST. The baseline characteristics of patients will be summarised and compared using the t test or non-parametric statistical test. Qualitative data will be analysed using the χ2 or Fisher exact tests, Cochran–Mantel–Hasenszel test and Wilcoxon test.Ethics and disseminationThis trial has been approved by the Research Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2017] 0021). Written informed consent will be obtained from all participants. The results of this trial will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registrationThis study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR1800015911.

scholarly journals Anticoagulant therapy for non-ST-segment elevation acute coronary syndrome in China: A multi-center observational study

2016 ◽  
Vol 4 (1) ◽  
pp. 25-28 ◽  
Author(s):  
Xiao-huan Gong ◽  
Jin-ming Yu ◽  
Yong Mao ◽  
Da-yi Hu
Keyword(s):  
Acute Coronary Syndrome ◽  
Anticoagulant Therapy ◽  
Coronary Intervention ◽  
Efficacy And Safety ◽  
St Segment Elevation ◽  
Coronary Syndrome ◽  
St Segment ◽  
Percutaneous Coronary ◽  
Elevation Acute Coronary Syndrome ◽  
Lower Incidence Rate

Abstract Objective To assess the anticoagulant therapy for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) in China and to offer the rationale for establishing reasonable strategies to improve the prognosis of NSTE-ACS. Methods A total of 1,502 patients with NSTE-ACS were recruited from 28 third-grade hospitals distributed in 14 provinces and cities in China from December 2009 to December 2011. The strategies for diagnosis and treatment, decided by each hospital respectively, were used for further analysis and comparison of medication, percutaneous coronary intervention (PCI), and end points for efficacy and safety assessment at 9 and 30 days following PCI. Results A lower incidence rate (P < 0.05) was noted for efficacy and safety in patients with unstable angina (UA) than those with non-ST-segment elevation myocardial infarction (NSTE-MI). The prescription rate of unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), fondaparinux, PCI, and single medication was 0.61%, 66.42%, 30.61%, 69.64%, and 70.74%, respectively. Conclusion Compared with NSTE-MI, UA is featured with better prognosis, less severity, and different outcome. However, in clinical practice, the therapies for NSTE-MI and UA show no differences, which deserves great attention. In China, the most common anticoagulant therapies for NSTE-ACS are single medication, mainly based on LMWH and PCI.

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

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