Medicure has reported that its Aggrastat (tirofiban hydrochloride) injection met the primary goal of combined efficacy and major bleeding in the shortened Aggrastat versus Integrilin in percutaneous coronary intervention (SAVI-PCI) clinical trial.
A non-peptide antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor, the antiplatelet medication Aggrastat hinders the last common pathway in the aggregation of platelets.
It is intended to reduce the thrombotic cardiovascular events rate in individuals with non-ST elevation acute coronary syndrome (NSTE-ACS).
Sponsored by Medicure, the multicentre, randomised, open-label trial enrolled 535 subjects at 13 centres in the US.
Subjects received a bolus plus one-two hour short infusion of Aggrastat or label-dosing of Integrilin given as double-bolus plus 12-18-hour infusion.
Later, a third cohort of bolus plus 12-18-hour long infusion of Aggrastat was added to the trial.
The non-inferiority of a composite of morality, urgent target vessel revascularisation or in-hospital, periprocedural myonecrosis (PPM), major bleeding within 48 hours after PCI or discharge from hospital, whichever occurred first, was the trial’s primary goal.
According to the trial findings, a short infusion of Aggrastat demonstrated to be non-inferior to its long-infusion, as well as label-dosing Integrilin in the primary goal.
The primary goal was driven by PPM incidence while one death was reported in the Integrilin group and two uTVR events in the short and long Aggrastat groups each.
No substantial difference in REPLACE-2 major bleeding events was observed between the short infusion Aggrastat or the Integrilin groups, however, a substantial decline was noted as against the long Aggrastat group.
Medicure CEO Albert Friesen said: “We are very pleased to announce that the SAVI-PCI study met its primary endpoint, demonstrating the non-inferiority of a bolus plus short-infusion of Aggrastat when compared to longer infusion regimens.
“We believe that these results reflect the contemporary use of Aggrastat in the United States and are pleased to provide clinical evidence for its use.”