| Title | Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) versus alteplase (rt-PA) as fibrinolytic therapy for acute ST-segment elevation myocardial infarction (China TNK STEMI): protocol for a randomised, controlled, non-inferiority tr |
| Authors | Wang, Hai-bo Ji, Ping Zhao, Xing-Shan Xu, Haiyan Yan, Xiao-Yan Yang, Qin Yao, Chen Gao, Run-Lin Wu, Yang-feng Qiao, Shu-Bin |
| Affiliation | Peking Univ, Clin Res Inst, Beijing, Peoples R China. Hongkong Univ Sci & Technol, Shenzhen Peking Univ, Med Ctr, Shenzhen, Peoples R China. Peking Univ, Clin Med Coll 4, Beijing Jishuitan Hosp, Dept Cardiol, Beijing, Peoples R China. Chinese Acad Med Sci, Natl Ctr Cardiovasc Dis, Fuwai Hosp, Dept Cardiol, Beijing, Peoples R China. Peking Union Med Coll, Beijing, Peoples R China. Guangzhou Recomgen Biotech Co Ltd, Guangzhou, Guangdong, Peoples R China. Peking Univ, Clin Res Inst, Beijing, Peoples R China. Qiao, SB (reprint author), Chinese Acad Med Sci, Natl Ctr Cardiovasc Dis, Fuwai Hosp, Dept Cardiol, Beijing, Peoples R China. Qiao, SB (reprint author), Peking Union Med Coll, Beijing, Peoples R China. |
| Keywords | PERCUTANEOUS CORONARY INTERVENTION ASSOCIATION TASK-FORCE FRONT-LOADED ALTEPLASE THROMBOLYTIC THERAPY PRACTICE GUIDELINES STRATEGIES MANAGEMENT REGISTRY PCI |
| Issue Date | 2017 |
| Publisher | BMJ OPEN |
| Citation | BMJ OPEN.2017,7(9). |
| Abstract | Aim To evaluate the efficacy and safety of recombinant human TNK tissue-type plasminogen activator (rhTNKtPA) in lowering major adverse cardiovascular and cerebrovascular events (MACCEs) in Chinese acute ST-segment elevation myocardial infarction (STEMI) patients. Methods and analysis The study is designed as a multicentre, randomised, controlled non-inferiority phase IV trial with balanced randomisation (1: 1) in patients with STEMI. The planned sample size is 6200 participants (or 3100 per arm). Participants with STEMI will be randomised to receive either rhTNK-tPA or alteplase (rt-PA), with stratification by research centre, age and the time from symptom onset to randomisation. All patients will receive concomitant antiplatelet and anticoagulant therapy before fibrinolytic therapy. The participants assigned to the intervention group will receive an intravenous bolus of 16 mg rhTNK-tPA, while those assigned to the control group will receive an intravenous bolus of 8 mg rt-PA followed by 42 mg infusion over 90 mins. Other medications can also be administered at the discretion of the cardiologists in charge. All participants will be followed up for the primary study endpoint, the occurrence of MACCEs within 30 days after fibrinolytic therapy, which is defined as all-cause mortality, non-fatal re-infarction, non-fatal stroke, percutaneous coronary intervention (PCI) due to thrombolysis failure, and PCI due to reocclusion. Both intention-to-treat and per-protocol analyses will be done for the primary analyses. Ethics and dissemination The study procedures and informed consent form were approved by all participating hospitals. The results will be disseminated in peer review journals and academic conferences. This multicentre randomised controlled trial will provide high-quality data about the efficacy and safety of rhTNK-tPA and, once approved, its easier use should help improve the application of reperfusion therapy and hence the treatment outcomes of STEMI patients. |
| URI | http://hdl.handle.net/20.500.11897/470969 |
| ISSN | 2044-6055 |
| DOI | 10.1136/bmjopen-2017-016838 |
| Indexed | SCI(E) |
| Appears in Collections: | 北京积水潭医院 |
