FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Bologna
Treatments:
Abciximab Antibodies, Monoclonal Immunoglobulin Fab Fragments Tirofiban