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Safety and efficacy of prourokinase injection in patients with ST-elevation myocardial infarction: phase IV clinical trials of the prourokinase phase study

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Abstract

To evaluate the safety and efficacy in terms of infarct-related artery (IRA) patency of prourokinase (proUK) injection within 6 h after symptom onset in patients with ST-elevation myocardial infarction (STEMI). A total of 1851 patients with acute myocardial infarction were enrolled to receive thrombolytic therapy with proUK. Qualifying patients were injected with 20 mg proUK intravenously followed by intravenous infusion of 30 mg proUK within 30 min. IRA was evaluated by coronary angiography at 120 min after thrombolysis. The efficacy and safety of proUK thrombolysis were analyzed in all the enrolled patients. Successful clinical reperfusion was observed in 1580 patients (85.4%). The number of leads with ST segment elevation and the amplitude of ST segment elevation were significantly reduced within 24 h after thrombolytic therapy with proUK. Eighty-three patients (4.48%) had died by the end of follow-up (7 days after thrombolysis), and the incidences of post-infarction angina, re-infarction or reocclusion, and emergency revascularization were 15.2, 4.21, and 8.27%, respectively. The most common bleeding complication was subcutaneous or mucosal bleeding and the incidence of intracranial hemorrhage was as lower as 0.32%. The fibrinolysis therapy with proUK is efficient and safe with very low rate of bleeding complications. It provides an alternative treatment options for STEMI patients especially in settings where primary PCI cannot be offered in a timely manner.

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Acknowledgements

We wish to thank all the participant centers for their contributions and Tasly Pharmaceuticals for their funding support of the study.

List of centers (investigators): A total of 299 centers nationwide participated in the trial, here is the list of major participant centers (investigators): Tianjin People’s Hospital (Zhuhua Yao), Tianjin Chest Hospital (Hongliang Cong), PLA 464 Hospital (Shenghua Ding), Second Hospital of Tianjin Medical University (Yingzi Liang, Lifeng Li), Tianjin Fourth Centre Hospital (Huan Zhang), General Hospital of Ji’nan Military Command (Xiaoyan Li), Cardiology Department of Yan’an University Affiliated Hospital (Feng Gao), The First Affiliated Hospital of Baotou Medical College (Xiaohua Guo), Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Ben He), Affiliated Nanhua Hospital, University of South China (Xiaofeng Ma),North China University of Science and Technology Affiliated Hospital (Haitao Li), Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (Hongxu Liu), The Second Affiliated Hospital of XinJiang Medical University (Shunmin Liu).

Author information

Author notes

  1. Linru Zhao and Zhiqiang Zhao are contributed equally to this study and should be regarded as co-first authors.

Authors and Affiliations

  1. Department of Cardiology, the Second Hospital of Tianjin Medical University, Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Tianjin Institute of Cardiology, Tianjin, 300211, People’s Republic of China

    Linru Zhao, Zhiqiang Zhao & Guangping Li

  2. Division of Cardiology, Tianjin Nankai Hospital, Tianjin, 300100, People’s Republic of China

    Xiaolu Chen

  3. Tasly Pharmaceuticals, Tianjin, 300402, People’s Republic of China

    Jingyue Li & Jinping Liu

Authors
  1. Linru Zhao
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  2. Zhiqiang Zhao
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  3. Xiaolu Chen
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  4. Jingyue Li
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  5. Jinping Liu
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  6. Guangping Li
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Consortia

The Group of Prourokinase Phase IV Clinical Trials Investigators

  • Zhuhua Yao
  • , Hongliang Cong
  • , Shenghua Ding
  • , Yingzi Liang
  • , Lifeng Li
  • , Huan Zhang
  • , Xiaoyan Li
  • , Feng Gao
  • , Xiaohua Guo
  • , Ben He
  • , Xiaofeng Ma
  • , Haitao Li
  • , Hongxu Liu
  •  & Shunmin Liu

Corresponding author

Correspondence to Guangping Li.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in the study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

The members in The Group of Prourokinase Phase IV Clinical Trials Investigators are listed in Acknowledgements.

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Zhao, L., Zhao, Z., Chen, X. et al. Safety and efficacy of prourokinase injection in patients with ST-elevation myocardial infarction: phase IV clinical trials of the prourokinase phase study. Heart Vessels 33, 507–512 (2018). https://doi.org/10.1007/s00380-017-1097-x

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  • DOI: https://doi.org/10.1007/s00380-017-1097-x

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