drugset / Trial / NCT00383136

FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab

NCT00383136

Phase 4 Completed 692 enrolled University of Bologna
RandomizedParallel-groupOpen-labelTreatment

Summary

The elective("standard of care") treatment of ST - elevation acute myocardial infarction (STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor. Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used, i.e. 25 microg/kg, (platelet aggregation inhibition \> 90% 15 minutes after infusion). It can therefore be hypothesized that this drug can improve the results of primary angioplasty to the same extent as Abciximab. The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices, of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of treatment before transfer and of treatment in the catheterization laboratory during the procedure. The reference hypothesis for the study objective is the equivalence or the non-inferiority of Tirofiban with respect to Abciximab.

Timeline

Start
2003-06
Primary completion
2007-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abciximab Monoclonal antibody 0.125 ug/kg
Subject Tirofiban Other / unclassified 0.15 ug/kg