Myocardial Infarction
Conditions
Brief summary
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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Onset of symptoms of AMI within 6 hours from randomisation * A twelve-lead electrocardiogram (ECG) showing 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 new left bundle-branch block * Age ≥ 18
Exclusion criteria
* Hypertension defined as blood pressure \> 180/110 mmHg (systolic BP \> 180 mmHg and/or diastolic BP \> 110 mmHg) on repeated measurements during current admission prior to randomisation * Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours * Use of heparin within the preceding 12 hours * Current therapeutic oral anticoagulation * Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months * Any minor head trauma and any other trauma occurring after the onset of the current myocardial infarction * Any known history of stroke or transient ischemic attack or dementia * Any known structural damage of the central nervous system * Ruptured aortic aneurism * Active bleeding * Prolonged cardiopulmonary resuscitation (\> 10 minutes) in the previous two weeks * 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 enrolment in this study * Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy were initiated * Inability to follow the protocol and comply with follow-up requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in concentration of thrombin anti-thrombin complex (TAT) | Baseline, 2 hours after start of treatment |
Secondary
| Measure | 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 |
| 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 |
| Occurrence of serious adverse events (SAE's) | Up to 30 days |
| 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 in-hospital complications | Start of treatment until discharge from hospital |
| Changes from baseline in plasmin-antiplasmin complex (PAP) | Baseline, 2, 6 and 24 hours after start of treatment |
Outcome results
None listed