| Title | China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial |
| Authors | Xu, Yi Li, Xiangdong Zhang, Haitao Wu, Yuan Zhang, Jun Li, Jia Dou, Kefei Yan, Hongbing You, Shijie Yang, Yanmin Liang, Yan Xu, Lianjun Gao, Xiaojin Liu, Chen Dong, Qiuting Zhang, Wenjia Song, Guangyuan Zhang, Tao Jiang, Lin Chen, Guihao Tang, Ruijie Jin, Chen Yang, Jingang Yao, Chen Xian, Ying Peterson, Eric D. Gao, Runlin Yang, Yuejin |
| Affiliation | Chinese Acad Med Sci & Peking Union Med Coll, Natl Ctr Cardiovasc Dis, Fuwai Hosp, 167 Beilishi Rd, Beijing 100037, Peoples R China Peking Univ, Clin Res Inst, Beijing, Peoples R China Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA |
| Keywords | NO-REFLOW PHENOMENON ST-SEGMENT ELEVATION PERCUTANEOUS CORONARY INTERVENTION ISCHEMIA-REPERFUSION INJURY THERAPY PATHWAY GUIDELINES OUTCOMES LESION FORCE |
| Issue Date | Sep-2020 |
| Publisher | AMERICAN HEART JOURNAL |
| Abstract | Background 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 patientswith 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. |
| URI | http://hdl.handle.net/20.500.11897/591538 |
| ISSN | 0002-8703 |
| DOI | 10.1016/j.ahj.2020.06.011 |
| Indexed | SCI(E) |
| Appears in Collections: | 医学部待认领 |
