drugset / Trial / NCT02182011

A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)

NCT02182011

Phase 3 Completed 49 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2000-05
Primary completion
2001-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alteplase Protein / enzyme biologic Intravenous
Comparator Streptokinase Protein / enzyme biologic Intravenous
Subject Tenecteplase Protein / enzyme biologic Intravenous

Indications