A Phase 3 interventional study of GNR-060 and Metalyse in ST Elevation Myocardial Infarction, sponsored by AO GENERIUM. Completed at 11 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by AO GENERIUM · Phase 3, Interventional, and Treatment
GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST Elevation Myocardial Infarction (STEMI).
The trial is designed as a multicenter randomized single blinded study with the centralized blinded outcome assessment. The patients with diagnosed STEMI will be randomly assigned with one of the treatment options within 4 hours after the symptoms onset. The effectiveness of the tested product GNR-060 or reference product Metalyze will be assessed by the coronarography within 24 hours after the thrombolysis with the following PCI in case of ineffectiveness. The patients will then be followed up for survival and cardiac events for 90 days. The safety assessment will also include any related hemorrhagic complication. The pharmacokinetic parameters and immunogenicity will be also assessed.
Myocardial infarction with elevation of the ST segment of the ECG (at point J) in 2 adjacent leads after no more than 6 hours from the onset of pain (lasting at least 20 minutes) in the chest (at the time of screening):
Exclusion Criteria:
Main group (122 patients) - GNR-060
Biological: GNR-060
Control group (122 patients) - Metalyse
Biological: Metalyse
GNR-060 will be administered in an individual dose depending on body weight as a single intravenous bolus
Also known as: Tenecteplase
Metalyse will be administered in an individual dose depending on body weight as a single intravenous bolus
Also known as: Tenecteplase
Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography
TIMI Grade 3 coronary blood flow after the trombolisis
Time frame: up to 24 hours
Frequency of the complete+partial myocardial reperfusion based on the independent assessment of coronary angiography
TIMI Grade 2 or 3 coronary blood flow after the trombolisis
Time frame: up to 24 hours
Frequency of myocardial reperfusion based on ECG data
Resolution of the ST segment by 30%, 50%, 70% or more
Time frame: after 90 minutes
Changes in troponin T and creatine kinase MB levels
Time frame: 7 days
90-Day mortality
Mortality within 90 days after myocardial infarction
Time frame: 90 days
30-Day and 90-Day cardiovascular mortality
Cardiovascular mortality up to 30 and 90 days after myocardial infarction
Time frame: 30 and 90 days
Frequency of the postinfarction complications
Frequency of any postifarction complication except for arrythmias
Time frame: up to 30 days
Frequency of the combined events "cardiovascular death + recurrent myocardial infarction + stroke" and "cardiovascular death + recurrent myocardial infarction + stroke + heart failure"
Time frame: 30 days
Frequency and severity of hemorrhagic complications
Hemorragies will be classified based on BARC, ISTH and TIMI definitions
Time frame: up to 30 days
Incidence of the hemorrhagic stroke
Any case of treatment-related hemorrhagic stroke
Time frame: up to 30 days
Frequency and severity of the adverse drug reactions
Any adverse events related to the trombolisis
Time frame: up to 30 days
Proportion of patients with the antidrug antibodies
Anti-tenecteplaze antibody will be measured before trombolisis and 7 days after.
Time frame: 7 days
Plan to share: No
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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ST Elevation Myocardial Infarction→
AO GENERIUM