Recombinant Streptokinase Versus Urokinase in Pulmonary Embolism in China (RESUPEC)
Condition: Pulmonary Embolism; Pulmonary Thromboembolism
MeSH terms: Pulmonary Embolism; Embolism; Thromboembolism
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Pulmonary embolism (PE) is a common cardiovascular illness. Massive PE is characterized with
      cardiogenic shock and/or persistent arterial hypotension. Submassive PE patients are defined
      with right ventricular dysfunction (RVD) identified by echocardiography or CT and the etc.
      The mortality of massive and submassive PE is higher than low-risk PE. PE has the mortality
      rate of >15% in the first 3 months after diagnosis. Thrombolytic treatment should be
      commenced as soon as possible after high-risk PE was diagnosed. Thrombolysis has been proved
      to be the most rapid and effective therapy to reduce the obstruction of pulmonary circulation
      and normalize hemodynamic parameters. The ultimate goals of thrombolytic therapy for this
      disease are to minimize early morbidity and mortality and to prevent recurrence without
      provoking excessive bleeding.

      Currently, the choice of thrombolytic agents and regimens (SK, UK or rt-PA) is mostly based
      on personal or regional preferences. A novel dosing regimen of UK (3 million IU/2h, or 4400
      IU/kg as a loading dose followed by 4400 IU/kg/h over 12h) and SK (1.5 million IU /2h) have
      been recommended in ESC guidelines. Considering lower body weight in Chinese population, a
      relative lower dosage UK-2h (20,000 IU/kg) regimen combined with low molecular weight heparin
      (LMWH) has been used in Chinese population. Our previous study has revealed that the efficacy
      and safety of UK-2h (20 000 IU/Kg) were similar with UK-12h (standard regimen) in Chinese
      patients. Thus the UK-2h (20,000 IU/Kg) became a popular and alternative choice in treating
      PE in China for its lower cost and convenience. Natural streptokinase (n-SK or SK) is an old
      thrombolytic agent. However, its immunogenicity lowers its safety and that constitute a
      concern among doctors. In recent years, as the development of gene engineering, r-SK was
      produced. R-SK has the advantage of not containing streptolysin and streptodornase unlike
      streptococci-derived n-SK which might make it safer theoretically. For its low cost, r-SK has
      been used to treat AMI especially in developing countries. In this study, the efficacy and
      safety between r-SK (1.5 million IU/2h) and UK-2h (20 000U/Kg) for treating acute PE will be
      compared. The study is conducted in patients with massive PE and submassive PE. The clinical
      efficacy, emboli dissolving efficacy and safety will be evaluated.
    

Intervention name(s): Recombinant Streptokinase; Urokinase
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours; Urokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours
Intervention MeSH terms: Streptokinase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary embolism; thrombolysis; massive; submassive; recombinant streptokinase; urokinase