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 compared to placebo.

Condition	Treatment or Intervention	Phase
Myocardial Ischemia	Drug: eptifibatide	Phase III

Further Study Details: 

Expected Total Enrollment:  10500

Ages Eligible for Study:  61 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• willing and able to give informed consent and comply with study procedures and follow-up through 1 year
• experiencing chest pain at rest with episodes lasting at least 10 minutes
• age >60 years old, have an abnormal electrocardiogram, and/or blood tests positive for heart damage
• able to be randomized in the trial within 8 hours of emergency room presentation of symptoms and will undergo invasive procedure (cardiac catheterization) no sooner than the next calendar day.

Exclusion Criteria:

• pregnancy (known or suspected)
• renal dialysis within 30 days prior to randomizing in study on either placebo or INTEGRILIN
• 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, bleeding disorders, or recent surgery at randomization into the trial

Linda Zillman      919-668-8870 

North Carolina
      Duke Clinical Research Institute, Durham,  North Carolina,  27705,  United States; Recruiting

Study ID Numbers:  M-INTG03-062/PO3684
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  August 17, 2004
ClinicalTrials.gov Identifier:  NCT00089895
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08