drugset / Trial / NCT02835534
The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI
Phase 4
Completed
818 enrolled
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Chinese Academy of Medical Sciences, Fuwai Hospital · collabPeking University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients. It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.
Timeline
- Start
- 2016-05
- Primary completion
- 2019-10
- Completion
- 2020-01
Outcome
Met primary endpoint
paper rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery PMID 37265385 ↗
Publications
- Zhao X, Zhu Y, Zhang Z, Tao G, Xu H, Cheng G, Gao W, Ma L, Qi L, Yan X, Wang H, Xia Q, Yang Y, Li W, Rong J, Wang L, Ding Y, Guo Q, Dang W, Yao C, Yang Q, Gao R, Wu Y, Qiao S. Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction: A randomized non-inferiority trial. Chin Med J (Engl). 2024 Feb 5;137(3):312-319. doi: 10.1097/CM9.0000000000002731. Epub 2023 Jun 2.
- Wang HB, Ji P, Zhao XS, Xu H, Yan XY, Yang Q, Yao C, Gao RL, Wu YF, Qiao SB. 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 trial. BMJ Open. 2017 Sep 18;7(9):e016838. doi: 10.1136/bmjopen-2017-016838.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alteplase | Protein / enzyme biologic | 50 mg | Intravenous |
| Subject | Tenecteplase | Protein / enzyme biologic | 16 mg | Intravenous |