ST Elevation Myocardial InfarctionPhase 3NCT05601999
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
A Phase 3 study testing GNR-060 and Metalyse in people with ST Elevation Myocardial Infarction, run by AO GENERIUM at 11 sites in Russia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- GNR-060 and Metalyse
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 11 sitesRussia
- Study dates
- 3 Sep 2021to 15 Jan 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- ≥ 2.5 mm in male ˂ 40 years, ≥ 2 mm in male ≥ 40 years, or ≥ 1.5 mm in female in leads V2-V3 and/or
- ≥ 1 mm in other leads in the absence of left ventricular hypertrophy or left bundle branch block.
Who cannot join
- Diseases accompanied by significant bleeding, currently or within the last 6 months, hemorrhagic diathesis.
- Current oral anticoagulant therapy with INR > 1.3.
- Diseases of the central nervous system at present or in history (neoplasm, aneurysm, surgery on the brain or spinal cord).
- Severe uncontrolled arterial hypertension.
- Major surgical interventions, biopsy of a parenchymal organ or significant trauma within the last 2 months (including trauma in combination with AMI at the present time), recent (within the last 3 months) traumatic brain injury.
- Prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes) within the last 2 weeks.
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- Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (including esophageal varicose veins), active hepatitis.
- Peptic ulcer of the stomach or duodenum in the acute stage.
- Chronic kidney disease or other significant kidney disease with a decrease in glomerular filtration rate ≤30 ml / min / 1.73 m2.
- Arterial aneurysm or presence of arterial/venous vascular malformation.
- Neoplasm with an increased risk of bleeding.
- Acute pericarditis and/or subacute bacterial endocarditis.
- Acute pancreatitis.
- Hypersensitivity to the active substance (tenecteplase), gentamicin (residual traces of the manufacturing process) or any excipient.
- Hemorrhagic stroke or stroke of unknown etiology at present or in history.
- Intracranial (including subarachnoid) hemorrhage at present or in history.
- Ischemic stroke or transient ischemic attack (TIA) within the last 6 months.
- Recent bleeding from the gastrointestinal or genitourinary tract or childbirth (within the last 10 days).
- A recent (before 24 hours) puncture of an incompressible blood vessel (eg, subclavian or jugular vein).
- Congenital and hereditary hemorrhagic coagulopathy (hemophilia, etc.) in history.
- Pregnancy or breastfeeding.
- Body mass index (BMI) less than 18.5 or more than 40 kg/m2.
- Participation in another clinical trial currently or within 30 days prior to screening; use of any investigational drug within 30 days or 5 half-lives prior to screening.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
State Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Arkhangelskaya oblast, 163001
Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"
Barnaul, Altai Territory, 656038
Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary"
Barnaul, Altai Territory, 656055
Regional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph"
Belgorod, Belgorod Oblast, 308007
State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"
Kazan', Tatarstan Republic, 420101
State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"
Perm, Perm Territory, 614107
Municipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don"
Rostov-on-Don, Rostov Oblast, 344068
State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"
Ryazan, Ryazan Oblast, 390039
State Health Institution "City Clinical Emergency Hospital No. 25"
Volgograd, Volgograd Oblast, 400138
State Budgetary Health Institution of the Yaroslavl Region "Regional Clinical Hospital"
Yaroslavl, Yaroslavl Oblast, 150062
State budgetary health care institution of the Sverdlovsk region "Scientific and practical center for specialized types of medical care" Ural Institute of Cardiology "
Yekaterinburg, Sverdlovsk Oblast, 620144
About this study
Official title: Multicenter Randomized Single Blind Study of the Clinical Efficacy and Safety of GNR-060 (JSC "GENERIUM", Russia) Compared to Metalyse (Boehringer Ingelheim Pharma GmbH & Co.KG, Germany) in Patients With ST Elevation Myocardial Infarction
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).
Read the detailed description
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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- GNR-060, Metalyse
- Keywords
- Myocardial Infarction, ST Elevation, ECG, STEMI, Myocardial Ischemia, Coronary Thrombosis, Thrombolysis, Thrombolytic, Thrombolytic therapy, Fibrinolytic therapy, Fibrinolysis, Bleeding, Hemorrhagic syndrome, Haemorrhage, Hemorrhagic stroke, Coronary angiography, Revascularization, Reperfusion, Tenecteplase, Metalyse
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Myocardial Ischemia, Coronary Thrombosis, Hemorrhage, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNR-060Biological
Also called Tenecteplase
GNR-060 will be administered in an individual dose depending on body weight as a single intravenous bolus
MetalyseBiological
Also called Tenecteplase
Metalyse will be administered in an individual dose depending on body weight as a single intravenous bolus
| Study group | Role | What they receive |
|---|---|---|
| GNR-060 | Experimental | Main group (122 patients) - GNR-060 Receives: Biological: GNR-060 |
| Metalyse | Active comparator | Control group (122 patients) - Metalyse Receives: Biological: Metalyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography
TIMI Grade 3 coronary blood flow after the trombolisis
Measured: up to 24 hours
Secondary outcomes (7)
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
Measured: up to 24 hours
Frequency of myocardial reperfusion based on ECG data
Resolution of the ST segment by 30%, 50%, 70% or more
Measured: after 90 minutes
Changes in troponin T and creatine kinase MB levels
Measured: 7 days
90-Day mortality
Mortality within 90 days after myocardial infarction
Measured: 90 days
30-Day and 90-Day cardiovascular mortality
Cardiovascular mortality up to 30 and 90 days after myocardial infarction
Measured: 30 and 90 days
Frequency of the postinfarction complications
Frequency of any postifarction complication except for arrythmias
Measured: up to 30 days
Frequency of the combined events "cardiovascular death + recurrent myocardial infarction + stroke" and "cardiovascular death + recurrent myocardial infarction + stroke + heart failure"
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start3 Sep 2021
- Primary completion6 May 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana A. Markova, MD, MSc, Study chair, AO GENERIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601999
- Sponsor's protocol ID
- TNP-STEMI-III
- Other IDs
- № 142 eff. date 17 March 2021
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No