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      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

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          Abstract

          Introduction

          Unstable 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 analysis

          This 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 χ 2 or Fisher exact tests, Cochran–Mantel–Hasenszel test and Wilcoxon test.

          Ethics and dissemination

          This 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 registration

          This study was registered on the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/) with the ID ChiCTR1800015911.

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          World Health Organization definition of myocardial infarction: 2008-09 revision.

          Kristian Thygesen, M Mähönen, Simona Giampaoli … (2011)
          WHO has played a leading role in the formulation and promulgation of standard criteria for the diagnosis of coronary heart disease and myocardial infarction since early 1970s. The revised definition takes into consideration the following: well-resourced settings can use the ESC/ACC/AHA/WHF definition, which has new biomarkers as a compulsory feature; in resource-constrained settings, a typical biomarker pattern cannot be made a compulsory feature as the necessary assays may not be available; the definition must also have provision for diagnosing non-fatal events with incomplete information on cardiac biomarkers and the ECG; to facilitate epidemiologic monitoring definition must recognize fatal events with incomplete or no information on cardiac biomarkers and/or ECG and/or autopsy and/or coronary angiography. Category A definition is the same as ESC/ACC/AHA/WHF definition of MI, and can be applied to settings with no resource constraints. Category B definition of MI is to be applied whenever there is incomplete information on cardiac bio-markers together with symptoms of ischaemia and the development of unequivocal pathological Q waves. Category C definition (probable MI) is to be applied when individuals with MI may not satisfy Category A or B definitions because of delayed access to medical services and/or unavailability of electrocardiography and/or laboratory assay of cardiac biomarkers. In these situations, the term probable MI should be used when there is either ECG changes suggestive of MI or incomplete information on cardiac biomarkers in a person with symptoms of ischaemia with no evidence of a non-coronary reason. This article presents the 2008-09 revision of the World Health Organization (WHO) definition of myocardial infarction (MI) developed at a WHO expert consultation.
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            Protective Effects of Panax Notoginseng Saponins on Cardiovascular Diseases: A Comprehensive Overview of Experimental Studies

            Xiaochen Yang, Xingjiang Xiong, Heran Wang … (2014)
            Panax notoginseng saponins (PNS) are one of the most important compounds derived from roots of the herb Panax notoginseng which are traditionally used as a hemostatic medicine to control internal and external bleeding in China for thousands of years. To date, at least twenty saponins were identified and some of them including notoginsenoside R1, ginsenoside Rb1, and ginsenoside Rg1 were researched frequently in the area of cardiovascular protection. However, the protective effects of PNS on cardiovascular diseases based on experimental studies and its underlying mechanisms have not been reviewed systematically. This paper reviewed the pharmacology of PNS and its monomers Rb1, Rg1, and R1 in the treatment for cardiovascular diseases.
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              Panax notoginseng reduces atherosclerotic lesions in ApoE-deficient mice and inhibits TNF-alpha-induced endothelial adhesion molecule expression and monocyte adhesion.

              Simon Lee, X. Kang, Wei He … (2009)
              It is widely recognized that atherogenesis is associated with vascular inflammation. Panax notoginseng , a commonly used herb in China, has been shown to possess anti-inflammatory activity. In the present study, the antiatherogenic effect of P. notoginseng saponins (PNS) was examined in apolipoprotein E (apoE)-deficient mice. The molecular mechanisms responsible for the antivascular inflammatory effect of PNS on human coronary artery endothelial cells (HCAECs) were also investigated in vitro. PNS, dissolved in drinking water, was administered orally to two treatment groups at dosages of 4.0 and 12.0 mg/day/mouse, respectively. After 8 weeks, atherosclerosis in the entire aortic area was assessed using an en face method. Compared with the control group, both low- and high-dose PNS-treated groups showed a significant decrease in extent of atherosclerotic lesions by 61.4 and 66.2%, respectively (P < 0.01). PNS also notably reduced serum lipid levels. Serum levels of IL-6 and TNF-alpha in all groups of apoE-deficient mice were below the detection limit. In vitro studies showed that PNS dose-dependently inhibited monocyte adhesion on activated endothelium, as well as the expression of TNF-alpha-induced endothelial adhesion molecules, such as ICAM-1 and VCAM-1. In conclusion, PNS has antiatherogenic activity through, at least in part, its lipid-lowering and antivascular inflammatory mechanisms.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2020
                Publication date (Electronic): 26 August 2020
                Volume: 10
                Issue: 8
                Electronic Location Identifier: e038074
                Affiliations
                [1 ]departmentDepartment of Geriatrics , The First Affiliated Hospital of Guangzhou University of Chinese Medicine , Guangzhou, Guangdong, China
                [2 ]departmentLingnan Medical Research Center , Guangzhou University of Chinese Medicine , Guangzhou, Guangdong, China
                [3 ]departmentThe First Clinical College , Guangzhou University of Chinese Medicine , Guangzhou, Guangdong, China
                [4 ]departmentNational Drug Clinical Trial Agency Office , Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital , Guangzhou, Guangdong, China
                [5 ]departmentClinical Research and Data Center , Guangzhou University of Chinese Medicine , Guangzhou, Guangdong, China
                Author notes
                [Correspondence to ] Dr Zhongqi Yang; yang_zhongqi@ 123456163.com
                Author information
                http://orcid.org/0000-0002-9849-5077
                http://orcid.org/0000-0003-3582-2672
                Article
                Publisher ID: bmjopen-2020-038074
                DOI: 10.1136/bmjopen-2020-038074
                PMC ID: 7451462
                PubMed ID: 32847917
                SO-VID: 2c2ab7f4-0511-46c9-95ac-0d8c92097762
                Copyright © © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 26 February 2020
                Date revision received : 10 July 2020
                Date accepted : 17 July 2020
                Funding
                Funded by: the second batch of national Traditional Chinese Medicine(TCM) clinical research base project;
                Award ID: 2018131
                Funded by: This study has been supported by the National Key Research and Development Plan;
                Award ID: 2018YFC1707401
                Categories
                Subject: Cardiovascular Medicine
                Subject: 1506
                Subject: 1683
                Series title: Protocol
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: cardiology,adult cardiology,coronary heart disease
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: cardiology, adult cardiology, coronary heart disease

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