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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"
Barnaul, Altai Territory, Russia
NOT_YET_RECRUITINGFrequency 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
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Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary"
Barnaul, Altai Territory, Russia
RECRUITINGState Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Arkhangelskaya oblast, Russia
RECRUITINGRegional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph"
Belgorod, Belgorod Oblast, Russia
RECRUITINGState Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"
Perm, Perm Territory, Russia
RECRUITINGMunicipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don"
Rostov-on-Don, Rostov Oblast, Russia
RECRUITINGState Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"
Ryazan, Ryazan Oblast, Russia
NOT_YET_RECRUITINGState 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, Russia
RECRUITINGState Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"
Kazan', Tatarstan Republic, Russia
NOT_YET_RECRUITINGState Health Institution "City Clinical Emergency Hospital No. 25"
Volgograd, Volgograd Oblast, Russia
NOT_YET_RECRUITING...and 1 more locations