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
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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.
851 studies on the registry are indexed under ST Elevation Myocardial Infarction; 198 are open to participants now.
This study's enrollment of 244 is above the median of 193 across 528 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →AO GENERIUM is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Myocardial infarction with elevation of the ST segment of the (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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in May 2024, 32 months.
Of 38 phase 3 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's 32 months is below that.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Tenecteplase
ST Elevation Myocardial Infarction →