Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values.
Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase | Experimental | Single i.v. bolus followed by infusion, weight adjusted |
|
| Alteplase | Active Comparator | Single i.v. bolus followed by infusion |
|
| Streptokinase | Active Comparator | I.V. infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug |
| ||
| Alteplase |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in concentration of thrombin anti-thrombin complex (TAT) | Baseline, 2 hours after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in TAT | Baseline, 6 and 24 hours after start of treatment | |
| Changes from baseline in D-dimers | Baseline, 2, 6 and 24 hours after start of treatment | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Streptokinase | Drug |
|
| Changes from baseline in prothrombin fragments 1+2 (F1+F2) |
| Baseline, 2, 6 and 24 hours after start of treatment |
| Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1) | Baseline, 2, 6 and 24 hours after start of treatment |
| Changes from baseline in plasmin-antiplasmin complex (PAP) | Baseline, 2, 6 and 24 hours after start of treatment |
| Occurrence of adverse events (AE's) | Up to 30 days |
| Occurrence of major bleedings | Up to 30 days |
| Occurrence of minor bleedings | Up to 30 days |
| Occurrence of serious adverse events (SAE's) | Up to 30 days |
| Occurrence of in-hospital complications | Start of treatment until discharge from hospital |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D010959 | Tissue Plasminogen Activator |
| D013300 | Streptokinase |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
| D001685 | Biological Factors |
Not provided
Not provided