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Schering-Plough Announces Results of the Early ACS Trial
Date:3/30/2009

ide," said Robert Giugliano, MD, lead author of the EARLY ACS study, associate physician at Brigham and Women's Hospital and associate professor at Harvard Medical School.

EARLY ACS Study Design

EARLY ACS randomly allocated 9,492 patients with high-risk non-ST-segment elevation ACS to one of two strategies: early routine eptifibatide, or early placebo with delayed provisional eptifibatide commenced after angiography but pre-PCI. After randomization, patients received double-blinded early eptifibatide (180 mcg/kg intravenous double bolus [10 minutes apart] and 2.0 mcg/kg/min [1.0 mcg/kg/min if creatinine clearance <50 mL/min] infusion), or matching placebo. For bleeding, the investigator could decrease study drug infusion by one-third.

After angiography but pre-PCI, investigators could request a PCI study drug kit (to ensure eptifibatide was used during PCI while maintaining the original blind) containing bolus treatment (either eptifibatide or placebo) opposite to the randomized treatment assignment. Following kit administration, an open-label eptifibatide infusion was continued for 18-24 hours post-procedure. If provisional study drug was not administered pre-PCI, the initial infusion was continued unchanged for 18-24 hours post-PCI. If a thrombotic complication occurred after the wire crossed the lesion, investigators could request a bailout PCI kit containing bolus therapy opposite to initial treatment assignment.

For patients undergoing PCI, infusion duration was less than or equal to 96 hours (longer infusions were permitted to ensure a minimum 18-hour infusion post-PCI). In patients undergoing coronary artery bypass graft (CABG) surgery, the infusion continued until 2 hours preoperative (maximum 120 hours). Patients without revascularization received an infusion of less than or equal to 96 hours.

Aspirin (162-325 mg orally or 150-500 mg intravenously) was requir
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