EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00089895|
Recruitment Status : Completed
First Posted : August 19, 2004
Results First Posted : December 21, 2009
Last Update Posted : May 9, 2017
Merck Sharp & Dohme Corp.
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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).
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia Acute Coronary Syndrome||Drug: Eptifibatide (Integrilin) Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)|
|Actual Study Start Date :||November 1, 2004|
|Actual Primary Completion Date :||November 1, 2008|
|Actual Study Completion Date :||November 1, 2008|
Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
Drug: Eptifibatide (Integrilin)
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.
Placebo Comparator: Placebo
Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
intravenous; delivery to match eptifibatide to maintain blind
Primary Outcome Measures :
- Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. [ Time Frame: 96 hours after randomization ]
Secondary Outcome Measures :
- Incidence of the Composite of Death/MI. [ Time Frame: 30 days after randomization ]
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