一项评估NSTACS治疗中早期应用依替巴肽临床效果的随机.pptVIP

在非ST段抬高的急性冠状动脉综合征(NSTACS)中早期应用血小板糖蛋白IIbIIIa受体拮抗剂：一项评估NSTACS治疗中早期应用依替巴肽临床效果的随机、双盲、安慰剂对照试验 Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Double-blind, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndromes Disclosures Funded by Millennium Pharmaceuticals and Schering Plough Individual disclosures Armstrong Braunwald Califf Gibson Giugliano Harrington Montalescot Newby Strony Van de Werf Study Structure—figure with the below components Exec Comm Steering Committee Sponsor Coordinating Centers—DCRI, TIMI, CVC DSMB Sites CEC Primary Objective To demonstrate the superiority of a strategy of early, routine eptifibatide begun shortly after presentation compared with a strategy of delayed, provisional use of eptifibatide pre-PCI in reducing the composite of death, MI, recurrent ischemia, and thrombotic bail-out within 96 hours in patients with high-risk NSTE ACS managed with an invasive strategy Study Design Key Exclusion Criteria Increased bleeding risk active bleeding or recent bleed Recent surgery or trauma Prior ICH or recent ischemic stroke Serious concomitant illness or pregnancy ESRD with dialysis 30 days Recent or planned use of direct thrombin inhibitor, fXa inhibitor, abciximab/tirofiban amendment 1: bivalirudin at PCI amendment 2: acute fondaparinux or bivalirudin Blinded Study Drug Administration Double bolus and infusion regimen 180 ug/Kg IV eptifibatide (or matching placebo) bolus as soon as possible after randomization Immediate initiation of 2 ug/Kg/min eptifibatide (or matching placebo) infusion (1 ug/Kg/min if CrCl 50 cc/min) Second 180 ug/Kg IV eptifibatide (or matching placebo) bolus 10 minutes after initial bolus Provisional, blinded transition to open label eptifibatide at time of PCI using blinded bolus kit PCI active if transition before wire crossed lesion PCI bail