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Clot-Busting copycat put to the test in heart attack care

NCT ID NCT05601999

NEW Disease control Sponsor: AO GENERIUM Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

This Phase 3 trial tests whether a tenecteplase biosimilar called GNR-060 works as well as the reference drug Metalyse in people having a severe heart attack known as ST elevation myocardial infarction. Participants receive a single weight-based intravenous dose of one drug or the other. Researchers compare how fully blood flow returns to the heart muscle, measured by coronary angiography and ECG changes, along with safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a tenecteplase biosimilar called GNR-060
What this could lead to
If it works as well as the reference drug, it could give patients another clot-dissolving option for heart attacks and widen access to this treatment.
What could go wrong
Biosimilars can differ slightly from the original drug in ways that affect how well they work or how the body reacts. The trial may show GNR-060 is not equivalent, and even a successful result would not change the need for emergency care and follow-up procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

244 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary thrombosis Hemorrhage Hemorrhagic Stroke myocardial infarction myocardial ischemia ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ST elevation myocardial infarction

Contacts and locations

Locations

  • Municipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don"

    Rostov-on-Don, Rostov Oblast, 344068, Russia

  • Regional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph"

    Belgorod, Belgorod Oblast, 308007, Russia

  • Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"

    Barnaul, Altai Territory, 656038, Russia

  • Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary"

    Barnaul, Altai Territory, 656055, Russia

  • State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"

    Kazan', Tatarstan Republic, 420101, Russia

  • State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"

    Perm, Perm Territory, 614107, Russia

  • State Budgetary Health Institution of the Yaroslavl Region "Regional Clinical Hospital"

    Yaroslavl, Yaroslavl Oblast, 150062, Russia

  • State Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"

    Arkhangelsk, Arkhangelskaya oblast, 163001, Russia

  • State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"

    Ryazan, Ryazan Oblast, 390039, Russia

  • State Health Institution "City Clinical Emergency Hospital No. 25"

    Volgograd, Volgograd Oblast, 400138, Russia

  • State budgetary health care institution of the Sverdlovsk region "Scientific and practical center for specialized types of medical care" Ural Institute of Cardiology "

    Yekaterinburg, Sverdlovsk Oblast, 620144, Russia

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