Clinical Trial: EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients with Non-ST-segment Elevation Acute Coronary Syndrome


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EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients with Non-ST-segment Elevation Acute Coronary Syndrome

This study is currently recruiting patients.

Sponsored by:	Millennium Pharmaceuticals Schering-Plough
Information provided by:	Millennium Pharmaceuticals

Purpose

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

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Early Glycoprotein IIb/IIIa Inhibition : 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

Further Study Details:

Expected Total Enrollment: 10500

Study start: May 2004; Study completion: April 2006

Eligibility

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

Location and Contact Information

Linda Zillman 919-668-8870

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

More Information

website containing information on the trial

Study ID Numbers: M-INTG03-062/PO3684
Record last reviewed: September 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 2004-11-10

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