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EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00089895
Recruitment Status : Completed
First Posted : August 19, 2004
Results First Posted : December 21, 2009
Last Update Posted : May 9, 2017
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Acute Coronary Syndrome Drug: Eptifibatide (Integrilin) Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Eptifibatide
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.
Other Names:
  • Integrilin
  • SCH 060936
  • SCH 60936

Placebo Comparator: Placebo
Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
Drug: Placebo
intravenous; delivery to match eptifibatide to maintain blind

Primary Outcome Measures :
  1. 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 :
  1. Incidence of the Composite of Death/MI. [ Time Frame: 30 days after randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00089895    
Other Study ID Numbers: P03684
First Posted: August 19, 2004    Key Record Dates
Results First Posted: December 21, 2009
Last Update Posted: May 9, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Merck Sharp & Dohme Corp.:
myocardial infarction
acute coronary syndrome
non-ST-segment elevation
glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa)
percutaneous coronary intervention (PCI)
coronary artery bypass graph surgery (CABG)
cardiac ischemia
cardiovascular disease
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors