ST Elevation Myocardial Infarction Clinical Trial
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).
Status | Recruiting |
Enrollment | 244 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | State Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich" | Arkhangel'sk | Arkhangelsk Region |
Russian Federation | Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital" | Barnaul | Altai Territory |
Russian Federation | Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary" | Barnaul | Altai Territory |
Russian Federation | Regional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph" | Belgorod | Belgorod Region |
Russian Federation | State budgetary health care institution of the Sverdlovsk region "Scientific and practical center for specialized types of medical care" Ural Institute of Cardiology " | Ekaterinburg | Sverdlovsk Region |
Russian Federation | State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center" | Kazan | Republic Of Tatarstan |
Russian Federation | State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4" | Perm | Perm Territory |
Russian Federation | Municipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don" | Rostov-on-Don | Rostov Region |
Russian Federation | State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital" | Ryazan' | Ryazan Region |
Russian Federation | State Health Institution "City Clinical Emergency Hospital No. 25" | Volgograd | Volgograd Region |
Russian Federation | State Budgetary Health Institution of the Yaroslavl Region "Regional Clinical Hospital" | Yaroslavl | Yaroslavl Region |
Lead Sponsor | Collaborator |
---|---|
AO GENERIUM |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency and severity of hemorrhagic complications | Hemorragies will be classified based on BARC, ISTH and TIMI definitions | up to 30 days | |
Other | Incidence of the hemorrhagic stroke | Any case of treatment-related hemorrhagic stroke | up to 30 days | |
Other | Frequency and severity of the adverse drug reactions | Any adverse events related to the trombolisis | up to 30 days | |
Other | Proportion of patients with the antidrug antibodies | Anti-tenecteplaze antibody will be measured before trombolisis and 7 days after. | 7 days | |
Primary | Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography | TIMI Grade 3 coronary blood flow after the trombolisis | up to 24 hours | |
Secondary | 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 | up to 24 hours | |
Secondary | Frequency of myocardial reperfusion based on ECG data | Resolution of the ST segment by 30%, 50%, 70% or more | after 90 minutes | |
Secondary | Changes in troponin T and creatine kinase MB levels | 7 days | ||
Secondary | 90-Day mortality | Mortality within 90 days after myocardial infarction | 90 days | |
Secondary | 30-Day and 90-Day cardiovascular mortality | Cardiovascular mortality up to 30 and 90 days after myocardial infarction | 30 and 90 days | |
Secondary | Frequency of the postinfarction complications | Frequency of any postifarction complication except for arrythmias | up to 30 days | |
Secondary | Frequency of the combined events "cardiovascular death + recurrent myocardial infarction + stroke" and "cardiovascular death + recurrent myocardial infarction + stroke + heart failure" | 30 days |
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