Myocardial Infarction Clinical Trial
Official title:
A Randomized, Multicenter, Double-Blind, Study to Evaluate the Efficacy of Tirofiban HCl Versus Placebo in the Setting of Standard Therapies Among Subjects Undergoing Percutaneous Coronary Intervention
The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v.
bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention
(PCI) plus two hours after the procedure) is more effective than placebo in the setting of
standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or
bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac
ischemic events defined as death, myocardial infarction (MI), and urgent target vessel
revascularization (uTVR) within 48 hours following study drug initiation.
A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus
followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure)
is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a
thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as
assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following
study drug initiation.
Patient enrollment is pending.
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