TY - JOUR
T1 - China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI)
T2 - Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial
AU - Xu, Yi
AU - Li, Xiangdong
AU - Zhang, Haitao
AU - Wu, Yuan
AU - Zhang, Jun
AU - Li, Jia
AU - Dou, Kefei
AU - Yan, Hongbing
AU - You, Shijie
AU - Yang, Yanmin
AU - Liang, Yan
AU - Xu, Lianjun
AU - Gao, Xiaojin
AU - Liu, Chen
AU - Dong, Qiuting
AU - Zhang, Wenjia
AU - Song, Guangyuan
AU - Zhang, Tao
AU - Jiang, Lin
AU - Chen, Guihao
AU - Tang, Ruijie
AU - Jin, Chen
AU - Yang, Jingang
AU - Yao, Chen
AU - Xian, Ying
AU - Peterson, Eric D.
AU - Gao, Runlin
AU - Yang, Yuejin
N1 - Publisher Copyright:
© 2020 The Authors
PY - 2020/9
Y1 - 2020/9
N2 - Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. Methods and results: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. Conclusions: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.
AB - Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. Methods and results: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. Conclusions: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.
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U2 - 10.1016/j.ahj.2020.06.011
DO - 10.1016/j.ahj.2020.06.011
M3 - Article
C2 - 32679281
AN - SCOPUS:85087753796
SN - 0002-8703
VL - 227
SP - 47
EP - 55
JO - American heart journal
JF - American heart journal
ER -