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

NCT05601999 | Recruiting Phase 3 DMC

• 2 other identifiers: TNP-STEMI-III№ 142 eff. date 17 March 2021
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

ST Elevation Myocardial Infarction

Keywords

Myocardial Infarction; ST Elevation; ECG; STEMI; Myocardial Ischemia; Coronary Thrombosis; Thrombolysis; Thrombolytic; Thrombolytic therapy; Fibrinolytic therapy; Fibrinolysis; Bleeding; Hemorrhagic syndrome; Haemorrhage; Hemorrhagic stroke; Coronary angiography; Revascularization; Reperfusion; Tenecteplase; Metalyse; Metalise; TNK-tPA; Fibrin-specific plasminogen activator; Recombinant DNA technology; AMI

Outcome Measures

Primary Outcomes (1)

• Frequency of the complete myocardial reperfusion based on the independent assessment of coronary angiography

  TIMI Grade 3 coronary blood flow after the trombolisis

  up to 24 hours

Secondary Outcomes (7)

• Frequency of the complete+partial myocardial reperfusion based on the independent assessment of coronary angiography

  up to 24 hours

• Frequency of myocardial reperfusion based on ECG data

  after 90 minutes

• Changes in troponin T and creatine kinase MB levels

  7 days

• 90-Day mortality

  90 days

• 30-Day and 90-Day cardiovascular mortality

  30 and 90 days

Other Outcomes (4)

• Frequency and severity of hemorrhagic complications

  up to 30 days

• Incidence of the hemorrhagic stroke

  up to 30 days

• Frequency and severity of the adverse drug reactions

  up to 30 days

Study Arms (2)

GNR-060

EXPERIMENTAL

Main group (122 patients) - GNR-060

Biological: GNR-060

Metalyse

ACTIVE COMPARATOR

Control group (122 patients) - Metalyse

Biological: Metalyse

Interventions

GNR-060 BIOLOGICAL

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

Also known as: Tenecteplase

GNR-060

Metalyse BIOLOGICAL

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

Also known as: Tenecteplase

Metalyse

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (11)

Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"

Barnaul, Altai Territory, 656038, Russia

NOT YET RECRUITING

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

Barnaul, Altai Territory, 656055, Russia

RECRUITING

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

Arkhangelsk, Arkhangelskaya oblast, 163001, Russia

RECRUITING

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

Belgorod, Belgorod Oblast, 308007, Russia

RECRUITING

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

Perm, Perm Territory, 614107, Russia

RECRUITING

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

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

RECRUITING

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

Ryazan, Ryazan Oblast, 390039, Russia

NOT YET RECRUITING

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

RECRUITING

State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"

Kazan', Tatarstan Republic, 420101, Russia

NOT YET RECRUITING

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

Volgograd, Volgograd Oblast, 400138, Russia

NOT YET RECRUITING

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

Yaroslavl, Yaroslavl Oblast, 150062, Russia

NOT YET RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction; Myocardial Ischemia; Coronary Thrombosis; Hemorrhage; Hemorrhagic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Thrombosis; Embolism and Thrombosis; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Oksana A. Markova, MD, MSc

  AO GENERIUM

  STUDY CHAIR

Central Study Contacts

Rusava O. Matyushina, MD, PhD

CONTACT

+7 (495) 988-47-94; romatyushina@generium.ru

Oksana A. Markova, MD, MSc

CONTACT

+7 (495) 988-47-94; oamarkova@generium.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 1, 2022
• Study Start: September 3, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11)