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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| METALYSE® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| METALYSE® | Drug | weight-adjusted dosage as single bolus over 5 to 10 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events (SAE) | up to 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |