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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
Time frame: Baseline, 2 hours after start of treatment
Changes from baseline in TAT
Time frame: Baseline, 6 and 24 hours after start of treatment
Changes from baseline in D-dimers
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in prothrombin fragments 1+2 (F1+F2)
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in plasmin-antiplasmin complex (PAP)
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Occurrence of adverse events (AE's)
Time frame: Up to 30 days
Occurrence of major bleedings
Time frame: Up to 30 days
Occurrence of minor bleedings
Time frame: Up to 30 days
Occurrence of serious adverse events (SAE's)
Time frame: Up to 30 days
Occurrence of in-hospital complications
Time frame: Start of treatment until discharge from hospital
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