EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Condition: Myocardial Ischemia; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Myocardial Ischemia; Syndrome; Ischemia
Intervention: Eptifibatide (Integrilin); Placebo
Intervention description: 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.; intravenous; delivery to match eptifibatide to maintain blind
Intervention MeSH terms: Eptifibatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 9406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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).
    

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.