Rationale and design of the Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51 (ATLAS-ACS 2 TIMI 51) trial: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome

2011 ◽  
Vol 161 (5) ◽  
pp. 815-821.e6 ◽  
Author(s):  
C. Michael Gibson ◽  
Jessica L. Mega ◽  
Paul Burton ◽  
Shinya Goto ◽  
Freek Verheugt ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Standard Therapy ◽  
Cardiovascular Events ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Coronary Syndrome

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.

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