EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Myocardial Ischemia, Acute Coronary Syndrome
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring 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
Eligibility Criteria
Inclusion Criteria: Willing and able to give informed consent and comply with study procedures and follow-up through 1 year. Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome. Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following: 60 years of age or more Electrocardiogram changes (ECG) Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels Or have all 3 of the following: Prior history of cardiovascular disease Elevated troponin or CK-MB levels 50-59 years of age Exclusion Criteria: pregnancy (known or suspected) renal dialysis within 30 days prior to randomizing in study other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma. History of certain hematologic problems following treatment with heparin or eptifibatide. Therapy with certain related drugs within a short time before randomization into the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Eptifibatide
Placebo
Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.