Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
ST Elevation Myocardial Infarction
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring 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, Metalise, TNK-tPA, Fibrin-specific plasminogen activator, Recombinant DNA technology, AMI
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"
- Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary"Recruiting
- State Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"Recruiting
- Regional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph"Recruiting
- State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"Recruiting
- State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"
- Municipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don"Recruiting
- State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"
- State budgetary health care institution of the Sverdlovsk region "Scientific and practical center for specialized types of medical care" Ural Institute of Cardiology "Recruiting
- State Health Institution "City Clinical Emergency Hospital No. 25"
- State Budgetary Health Institution of the Yaroslavl Region "Regional Clinical Hospital"
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
GNR-060
Metalyse
Main group (122 patients) - GNR-060
Control group (122 patients) - Metalyse