drugset / Trial / NCT00968929
Recombinant Streptokinase Versus Urokinase in Pulmonary Embolism in China (RESUPEC)
Phase 4
Completed
83 enrolled
Beijing Chao Yang Hospital
General Hospital of Shenyang Military Region · collabGuangdong Institute of Respiratory Disease · collabNingxia Medical University · collabQingdao University · collabShenzhen People's Hospital · collabThe First Affiliated Hospital of Shanxi Medical University · collabTianjin Medical University General Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene engineering. Its characteristics of high output and low production cost make it affordable in treating acute myocardial infarction (AMI) in developing countries. It is unclear whether r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000 IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.
Timeline
- Start
- 2006-06
- Primary completion
- 2009-05
- Completion
- 2009-05
Publications
- Background Zhu L, Yang Y, Wu Y, Zhai Z, Wang C. Value of right ventricular dysfunction for prognosis in pulmonary embolism. Int J Cardiol. 2008 Jun 23;127(1):40-5. doi: 10.1016/j.ijcard.2007.06.093. Epub 2007 Aug 22.
- Background Zhu L, Yang YH, Wu YF, Zhai ZG, Wang C; National Project of the Diagnosis and Treatment Strategies for Pulmonary Thromboembolism investigators. Value of transthoracic echocardiography combined with cardiac troponin I in risk stratification in acute pulmonary thromboembolism. Chin Med J (Engl). 2007 Jan 5;120(1):17-21.
- Background Zhu L, Wang C, Yang Y, Wu Y, Zhai Z, Dai H, Pang B, Tong Z. Value of transthoracic echocardiography in therapy regimens evaluation in pulmonary embolism. J Thromb Thrombolysis. 2008 Dec;26(3):251-6. doi: 10.1007/s11239-007-0087-8. Epub 2007 Aug 21.
- Background Yang Wang, Chen Wang, Yuanhua Yang, Baosen Pang. Effect of recombinant single-chain urokinase-type plasminogen activator on experimental pulmonary embolism. Clin Appl Thromb Hemost. 2010 Oct;16(5):537-42. doi: 10.1177/1076029609343003. Epub 2009 Oct 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Streptokinase | Protein / enzyme biologic | 1.5e+06 iu | Intravenous |
| Comparator | Urokinase | Protein / enzyme biologic | 20000 iu/kg | Intravenous |