Home › Trials › NCT05601999

Comparing GNR-060 and Metalyse for treating heart attacks

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

Phase 3 Interventional Ao Generium · NCT05601999

This study is testing if a new treatment called GNR-060 works as well as Metalyse for people having a heart attack, to see which one helps them recover better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment244 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAo Generium Industry-sponsored
Locations11 sites (Barnaul, Altai Territory and 10 other locations)
Trial IDNCT05601999 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of GNR-060, a proposed biosimilar, compared to Metalyse in patients experiencing ST Elevation Myocardial Infarction (STEMI). It is a multicenter, randomized, single-blinded study where patients diagnosed with STEMI will receive one of the two treatments within 4 hours of symptom onset. The effectiveness will be assessed through coronarography within 24 hours post-thrombolysis, followed by a 90-day follow-up for survival and cardiac events. Safety assessments will include monitoring for hemorrhagic complications and evaluating pharmacokinetic parameters and immunogenicity.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with STEMI who meet specific ECG criteria and can be treated within 6 hours of symptom onset.

Not a fit: Patients with significant bleeding disorders, recent major surgeries, or severe uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from STEMI.

How similar studies have performed: Other studies have shown success with similar thrombolytic agents, but the biosimilar approach of GNR-060 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Barnaul, Altai Territory and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ST Elevation Myocardial InfarctionMyocardial InfarctionST ElevationECGSTEMIMyocardial IschemiaCoronary ThrombosisThrombolysis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.