Status:
COMPLETED
Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI
Lead Sponsor:
Supergene, LLC
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 infarctio...
Detailed Description
Experimental Drug Profile. The active substance of Fortelyzin is Forteplase. It's recombinant protein which contains aminoacid sequence of staphylokinase. It is single chain molecula, consists of 138 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT02301910
Start Date
May 16 2014
End Date
December 1 2016
Last Update
March 20 2025
Active Locations (17)
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1
Institute of Cardiology
Tomsk, Siberia, Russia, 634012
2
St. Iosaf's Belgorod Regional Clinical Hospital
Belgorod, Russia, 308007
3
Kemerovo cardiological dispensary
Kemerovo, Russia, 650002
4
Research Institute of Complex Problems of Cardiovascular diseases
Kemerovo, Russia, 650002