Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infa… (NCT05601999) | Clinical Trial Compass
UnknownPhase 3
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
Russia244 participantsStarted 2021-09-03
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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…
What they're measuring
1
Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography