{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T09:31:13Z","timestamp":1765704673262,"version":"3.48.0"},"reference-count":21,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2020,8,26]],"date-time":"2020-08-26T00:00:00Z","timestamp":1598400000000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the second batch of national Traditional Chinese Medicine(TCM) clinical research base project","award":["2018131"],"award-info":[{"award-number":["2018131"]}]},{"name":"This study has been supported by the National Key Research and Development Plan","award":["2018YFC1707401"],"award-info":[{"award-number":["2018YFC1707401"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,7,17]]},"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Unstable angina (UA), referred to as\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.heart.org\/en\/health-topics\/heart-attack\/about-heart-attacks\/acute-coronary-syndrome\">acute coronary syndrome<\/jats:ext-link>\n                      (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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:italic>t<\/jats:italic>\n                      test or non-parametric statistical test. Qualitative data will be analysed using the \u03c7\n                      <jats:sup>2<\/jats:sup>\n                      or Fisher exact tests, Cochran\u2013Mantel\u2013Hasenszel test and Wilcoxon test.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      This study was registered on the Chinese Clinical Trial Registry (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/\">http:\/\/www.chictr.org.cn\/<\/jats:ext-link>\n                      ) with the ID ChiCTR1800015911.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-038074","type":"journal-article","created":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T02:15:26Z","timestamp":1598494526000},"page":"e038074","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["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"],"prefix":"10.1136","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9849-5077","authenticated-orcid":false,"given":"Wenjie","family":"Long","sequence":"first","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"},{"name":"Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huili","family":"Liao","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xi","family":"Huang","sequence":"additional","affiliation":[{"name":"The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qingqing","family":"Liu","sequence":"additional","affiliation":[{"name":"The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yaqing","family":"Tang","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Agency Office, Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liming","family":"Lu","sequence":"additional","affiliation":[{"name":"Clinical Research and Data Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianhong","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianhui","family":"Yuan","sequence":"additional","affiliation":[{"name":"National Drug Clinical Trial Agency Office, Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Ling","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Hong","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiao","family":"Duan","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weiji","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaoxiang","family":"Xian","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"},{"name":"Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3582-2672","authenticated-orcid":false,"given":"Zhongqi","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"},{"name":"Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"},{"name":"The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,8,26]]},"reference":[{"key":"2025121401291342000_10.8.e038074.1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0200017","article-title":"Long-Term moderately elevated LDL-cholesterol and blood pressure and risk of coronary heart disease","volume":"13","author":"Ueda","year":"2018","journal-title":"PLoS One"},{"key":"2025121401291342000_10.8.e038074.2","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9149(72)90624-8"},{"key":"2025121401291342000_10.8.e038074.3","doi-asserted-by":"publisher","DOI":"10.1021\/jf900529w"},{"key":"2025121401291342000_10.8.e038074.4","doi-asserted-by":"crossref","DOI":"10.1186\/1749-8546-6-37","article-title":"Comparative study on saponin fractions from Panax notoginseng inhibiting inflammation-induced endothelial adhesion molecule expression and monocyte adhesion","volume":"6","author":"Wang","year":"2011","journal-title":"Chin Med"},{"key":"2025121401291342000_10.8.e038074.5","first-page":"603","article-title":"Effect of Xueshuantong injection on cerebral infarction","volume":"15","author":"Gong","year":"2009","journal-title":"Hainan Yixueyuan Xuebao"},{"key":"2025121401291342000_10.8.e038074.6","doi-asserted-by":"crossref","first-page":"462","DOI":"10.1007\/s11655-009-0462-8","article-title":"Retrospective analysis of thrombolysis therapy for 64 cases of acute myocardial infarction with elevated ST segment","volume":"15","author":"Fu","year":"2009","journal-title":"Chin J Integr Med"},{"key":"2025121401291342000_10.8.e038074.7","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2019.00035","article-title":"Anti-Thrombosis effects and mechanisms by Xueshuantong capsule under different flow conditions","volume":"10","author":"Han","year":"2019","journal-title":"Front Pharmacol"},{"key":"2025121401291342000_10.8.e038074.8","first-page":"2446","article-title":"[Effects of Xueshuantong Injection on thrombosis formation and blood flow in rats].","volume":"45","author":"Liu","year":"2020","journal-title":"Zhongguo Zhong Yao Za Zhi"},{"key":"2025121401291342000_10.8.e038074.9","first-page":"4366","article-title":"[Effictiveness and safety of Xueshuantong Injection in treatment of unstable angina pectoris: a systematic review and Meta-analysis of randomized controlled trials].","volume":"44","author":"Gao","year":"2019","journal-title":"Zhongguo Zhong Yao Za Zhi"},{"key":"2025121401291342000_10.8.e038074.10","doi-asserted-by":"crossref","first-page":"551","DOI":"10.2147\/DDDT.S240511","article-title":"Focus on notoginsenoside R1 in metabolism and prevention against human diseases","volume":"14","author":"Liu","year":"2020","journal-title":"Drug Des Devel Ther"},{"key":"2025121401291342000_10.8.e038074.11","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"2025121401291342000_10.8.e038074.12","doi-asserted-by":"crossref","first-page":"314","DOI":"10.1001\/jamacardio.2019.0179","article-title":"Association of initial and serial C-reactive protein levels with adverse cardiovascular events and death after acute coronary syndrome: a secondary analysis of the VISTA-16 trial","volume":"4","author":"Mani","year":"2019","journal-title":"JAMA Cardiol"},{"key":"2025121401291342000_10.8.e038074.13","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/672508"},{"key":"2025121401291342000_10.8.e038074.14","first-page":"792","article-title":"Xueshuantong improves cerebral blood perfusion in elderly patients with lacunar infarction","volume":"8","author":"Gui","year":"2013","journal-title":"Neural Regen Res"},{"key":"2025121401291342000_10.8.e038074.15","doi-asserted-by":"crossref","first-page":"998","DOI":"10.1038\/aps.2017.128","article-title":"Xueshuantong injection (lyophilized) combined with Salvianolate lyophilized injection protects against focal cerebral ischemia\/reperfusion injury in rats through attenuation of oxidative stress","volume":"39","author":"Wang","year":"2018","journal-title":"Acta Pharmacol Sin"},{"key":"2025121401291342000_10.8.e038074.16","first-page":"348","article-title":"[Effect of intracoronary injection with xuesaitong in treating post-PCI slow-reflow phenomenon in patients with ST-segment elevation myocardial infarction]","volume":"30","author":"Gan","year":"2010","journal-title":"Zhongguo Zhong Xi Yi Jie He Za Zhi"},{"key":"2025121401291342000_10.8.e038074.17","doi-asserted-by":"crossref","first-page":"1162","DOI":"10.1002\/ptr.5848","article-title":"Panax notoginseng preparations for unstable angina pectoris: a systematic review and meta-analysis","volume":"31","author":"Song","year":"2017","journal-title":"Phytother Res"},{"key":"2025121401291342000_10.8.e038074.18","first-page":"4366","article-title":"[Effictiveness and safety of Xueshuantong Injection in treatment of unstable angina pectoris: a systematic review and Meta-analysis of randomized controlled trials]","volume":"44","author":"Gao","year":"2019","journal-title":"Zhongguo Zhong Yao Za Zhi"},{"key":"2025121401291342000_10.8.e038074.19","unstructured":"Zheng XY . Chinese medicine new drug clinical guidelines. Beijing, China: China Pharmaceutical Science and Technology Press, 2002: 392."},{"key":"2025121401291342000_10.8.e038074.20","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyq165"},{"key":"2025121401291342000_10.8.e038074.21","doi-asserted-by":"publisher","DOI":"10.1001\/jama.284.7.835"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-038074","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T09:29:26Z","timestamp":1765704566000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-038074"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8]]},"references-count":21,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2020,8,26]]},"published-print":{"date-parts":[[2020,8]]}},"alternative-id":["10.1136\/bmjopen-2020-038074"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-038074","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2020,8]]}}}