Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
- Conditions
- ST Elevation Myocardial Infarction
- Registration Number
- NCT05601999
- Lead Sponsor
- AO GENERIUM
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 244
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography up to 24 hours TIMI Grade 3 coronary blood flow after the trombolisis
- Secondary Outcome Measures
Name Time Method Frequency of the complete+partial myocardial reperfusion based on the independent assessment of coronary angiography up to 24 hours TIMI Grade 2 or 3 coronary blood flow after the trombolisis
Changes in troponin T and creatine kinase MB levels 7 days Frequency of myocardial reperfusion based on ECG data after 90 minutes Resolution of the ST segment by 30%, 50%, 70% or more
90-Day mortality 90 days Mortality within 90 days after myocardial infarction
30-Day and 90-Day cardiovascular mortality 30 and 90 days Cardiovascular mortality up to 30 and 90 days after myocardial infarction
Frequency of the postinfarction complications up to 30 days Frequency of any postifarction complication except for arrythmias
Frequency of the combined events "cardiovascular death + recurrent myocardial infarction + stroke" and "cardiovascular death + recurrent myocardial infarction + stroke + heart failure" 30 days
Trial Locations
- Locations (11)
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
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 "Belgorod Regional Clinical Hospital of St. Joasaph"
🇷🇺Belgorod, Belgorod Region, Russian Federation
State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"
🇷🇺Perm, Perm Territory, Russian Federation
State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"
🇷🇺Kazan, Republic Of Tatarstan, 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 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 Health Institution "City Clinical Emergency Hospital No. 25"
🇷🇺Volgograd, Volgograd Region, Russian Federation
Scroll for more (1 remaining)Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"🇷🇺Barnaul, Altai Territory, Russian Federation