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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-03

Study Completion Date

2024-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Single-blinded

Study Groups

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GNR-060

Main group (122 patients) - GNR-060

Group Type EXPERIMENTAL

GNR-060

Intervention Type BIOLOGICAL

GNR-060 will be administered in an individual dose depending on body weight as a single intravenous bolus

Metalyse

Control group (122 patients) - Metalyse

Group Type ACTIVE_COMPARATOR

Metalyse

Intervention Type BIOLOGICAL

Metalyse will be administered in an individual dose depending on body weight as a single intravenous bolus

Interventions

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GNR-060

GNR-060 will be administered in an individual dose depending on body weight as a single intravenous bolus

Intervention Type BIOLOGICAL

Metalyse

Metalyse will be administered in an individual dose depending on body weight as a single intravenous bolus

Intervention Type BIOLOGICAL

Other Intervention Names

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Tenecteplase Tenecteplase

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No