Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction

Launched by AO GENERIUM · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GNR-060, which is similar to an existing drug called Metalyse. Both medications are used to help dissolve blood clots in patients who have had a heart attack known as ST Elevation Myocardial Infarction (STEMI). The main goal of this study is to compare how effective and safe GNR-060 is compared to Metalyse in treating this condition.

To participate in the trial, patients should be experiencing a heart attack with specific changes in their heart's electrical activity, and they need to join within 6 hours of chest pain. However, certain health issues may prevent some people from joining, such as recent major bleeding, severe high blood pressure, or specific brain and kidney problems. Participants will receive treatment with either GNR-060 or Metalyse and will be monitored for safety and effectiveness. This study is currently looking for volunteers, so if you or a loved one fits the eligibility criteria, it may be a chance to contribute to important medical research.

Gender

ALL

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.