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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supergene, LLC
• Treatments: Tenecteplase; Tissue Plasminogen Activator

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

• cardiogenic shock (Killip class IV)

• 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