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Phase 3 N=382 Randomized Treatment

Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI

Myocardial Infarction

Enrolled (actual)
382
Serious AEs
21.7%
Results posted
Mar 2025
Primary outcome: Primary: The Number of Participants With Reperfusion — 133; 131 Participants — p=0.87

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Recombinant staphylokinase (Drug); Tenecteplase (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Supergene, LLC
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
The Number of Participants With Reperfusion
133; 131 0.87
SECONDARY
Composite Endpoint
24; 24
SECONDARY
Cardiovascular Death
7; 7
SECONDARY
Repeated Target Vessel Revascularization
2; 2
SECONDARY
Development of Heart Failure
15; 18
SECONDARY
Rehospitalization Due to Cardiovascular Reasons
0; 1
SECONDARY
Overall Bleeding
1; 1
SECONDARY
Intracranial Haemorrhages
0; 0

Summary

The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients presenting ST-segment elevation myocardial infarction in comparison to tenecteplase.

Eligibility Criteria

Inclusion Criteria

  • both gender patients over 18 years
  • 12-lead ECG indicative of an STEMI (ST-segment elevation in acute myocardial infarction, measured at the J point, should be found in two contiguous leads and be ≥0.25 mV in men below the age of 40 years, ≥0.2 mV in men over the age of 40 years, or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads (in the absence of left ventricular hypertrophy or left bundle branch block
  • the possibility of fibrinolysis within 12 hour of symptom onset
  • inability of primary PCI within 60 min of first medical contact (FMC)
  • informed consent received

Exclusion Criteria

  • expected performance of PCI less 60 min from FMC
  • left bundle branch block or ventricular pacing
  • cases of sinus bradycardia associated with hypotension, AV block II (Mobitz 2) or AV block III with bradycardia that causes hypotension or heart failure
  • active bleeding or known bleeding disorders/diathesis
  • uncontrolled hypertension, defined us single blood pressure measurement ≥180/110 mm Hg prior to randomization
  • internal bleeding within the past 2 weeks
  • conditions with increased risk of bleeding (peptic ulceration)
  • prolonged or traumatic resuscitation within the past 2 weeks
  • any known history of hemorrhagic stroke, or transitory ischemic attack
  • ischemic stroke within the past 3 month
  • puncture of unpressable vessels
  • aortic aneurism
  • intracranial neoplasm
  • any head trauma within past 2 weeks
  • intracranial vessel malformation
  • recent administration of anticoagulant within the past month
  • INR >1.3
  • sensibilisation to staphylokinase
  • contra-indications to acetylsalicilic acid, clopidogrel, enoxaparin
  • any conditions with unfavorable prognosis
  • in case of surgical treatment required within 30 days after randomization
  • in case of unhallowed medications required
  • pregnancy, lactation
  • inability to follow the protocol
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02301910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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