Prolonged Clinical Follow-up of OPTIMA-5
Condition: ST-segment Elevation Myocardial Infarction (STEMI)
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The OPTIMA-5 trial is a prospective, multi-center, randomized, patient blinded, controlled
      trial comparing a single bolus of half-dose recombinant staphylokinase (r-SAK) with normal
      saline (NS) in patients with ST-segment elevation myocardial infarction (STEMI) presenting
      ≤12 hours of symptom onset and expected to undergo primary percutaneous coronary intervention
      (PPCI) within 120 minutes. The results of OPTIMA-5 showed that a single bolus r-SAK prior to
      PPCI for STEMI improves infarct related artery (IRA) patency and reduces infarct size without
      increasing major bleeding. On this basis, this study was designed to investigate the effect
      of the novel reperfusion strategy on 1-year outcomes of patients with STEMI.
    

Detailed description: 
      Acute myocardial infarction (AMI) is one of the leading causes of death all over the world,
      and accounted for more than 100 thousand deaths in the US in 2019. Early PPCI reduces
      mortality in patients with STEMI. If PPCI cannot be performed within 120 minutes of
      presentation, guidelines recommend the use of thrombolytic therapy. However, it remains
      uncertain whether adjunctive thrombolytic therapy administered immediately prior to PPCI
      improves outcomes in patients undergoing the procedure within 120 minutes.

      SAK is a fibrin specific fibrinolytic agent produced by Staphylococcus aureus that was first
      discovered in 1948. A recombinant form of SAK was approved by China Food and Drug
      Administration (CFDA) for treatment of patients with STEMI. It has been demonstrated that
      r-SAK is more potent than urokinase and recombinant streptokinase in rabbit models.

      The OPTIMA-5 trial is an investigator-initiated, prospective, multi-center, randomized,
      patient blinded, controlled trial comparing a single bolus of half-dose r-SAK with NS in
      patients with STEMI presenting ≤12 hours of symptom onset and expected to undergo PPCI within
      120 minutes. Between October 29, 2021 and August 14, 2022, 283 STEMI patients were screened
      in 8 centers in China and 200 were randomized to r-SAK group or control in a 1:1 ratio using
      a computer-generated randomization sequence.

      On this basis, this study was aimed to conduct a 1-year follow-up study to further confirm
      the efficacy and safety of this novel reperfusion strategy for patients with STEMI.
    

Intervention name(s): Recombinant Staphylokinase; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction; Intravenous injection of normal saline is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ST Elevation Myocardial Infarction; Recombinant Staphylokinase