Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation

Study Overview
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Brief Summary
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Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation. Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction in usual routine treatment after market launch

Official Title
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A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: METALYSE®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: onset of symptoms of AMI within 6 hours on a twelve-lead electrocardiogram (ECG), ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or > 0.2 mV in two or more contiguous precordial leads indicative of AMI, or left bundle-branch block age ≥ 18 Exclusion Criteria: significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis patients with current concomitant oral anticoagulant therapy with International Normalised Ratio (INR) > 1.3 any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) severe uncontrolled arterial hypertension (hypertension defined as blood pressure 180/110 mm Hg (systolic BP > 180 mm Hg and/or diastolic BP > 100 mm Hg) on one single reliable measurement during current admission prior to study enrolment major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI), recent trauma to the head or cranium prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions active peptic ulceration arterial aneurysm and known arterial/venous malformation neoplasm with increased bleeding risk Acute pericarditis and/or subacute bacterial endocarditis Acute pancreatitis hypersensitivity to the active substance tenecteplase and to any of the excipients use of Abciximab (ReoPro®) or other marketed GPIIb/IIIa antagonists within the preceding 12 hours any minor head trauma and any other trauma occurring after onset of the current myocardial infarction any known history of stroke or transient ischemic attack or dementia pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test any known active participation in another investigative drug study or device protocol in the past 30 days previous enrollment in this study inability to follow protocol and comply with follow-up requirements any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| METALYSE®<br> | Drug: METALYSE®<br>* weight-adjusted dosage as single bolus over 5 to 10 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events (SAE) |  | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital rate of death |  | up to 30 days | 
| In-hospital rate of stroke |  | up to 30 days | 
| In-hospital rate of intracranial hemorrhage |  | up to 30 days | 
| In-hospital rate of major bleeding |  | up to 30 days | 
| In-hospital rate of non-fatal cardiac events |  | up to 30 days | 
| Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke |  | up to 30 days |