Phase 3
N=382
Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI
Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT02301910 ↗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
| Outcome | Result | p-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
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.