Conditions: Myocardial Ischemia Acute Coronary Syndrome
Keywords: myocardial infarction acute coronary syndrome non-ST-segment elevation eptifibatide Integrilin glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa) percutaneous coronary intervention (PCI) coronary artery bypass graph surgery (CABG) catheterization angina ischemia cardiac ischemia cardiovascular disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9406
Healthy volunteers: no

Brief summary:
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).

Detailed description:
This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.

Arms:
arm 1: Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. arm 2: Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

Interventions: intervention 1: Eptifibatide (Integrilin) intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG \[coronary artery bypass graft\]); second bolus of 180 mcg/kg administered 10 minutes after first bolus. intervention 2: intravenous; delivery to match eptifibatide to maintain blind

Protocol document: