Early ACS
Tracking Information
First Received Date 
August 17, 2004
Last Updated Date
December 17, 2008
Start Date 
November 2004
Current Primary Outcome Measures 
(submitted: January 3, 2008)
Incidence of the composite of death, myocardial infarction (MI), recurrent ischemia requiring urgent revascularization (RI-UR), and thrombotic bail-out.  
Original Primary Outcome Measures 
Same as current
Change History
Complete list of historical versions of study NCT00089895 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures 
(submitted: January 3, 2008)
Key secondary outcome is incidence of the composite of death/MI.  
Incidences of (1) MI and (2) the composite of death/MI.  
Incidence of the composite of death/MI/RI-UR  
Incidence of death.  
Original Secondary Outcome Measures 
Same as current
Descriptive Information
Brief Title 
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
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)
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.
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.
Study Phase
Phase III
Study Type 
Interventional
Study Design 
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition 
Myocardial Ischemia
Acute Coronary Syndrome
Intervention 
Drug: Eptifibatide (Integrilin)
Drug: Placebo
Study Arms / Comparison Groups
Experimental: Eptifibatide in addition to standard of care.
Placebo Comparator: Placebo in addition to standard of care.
Publications *
- Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status 
Completed
Estimated Enrollment 
Completion Date
November 2008
Primary Completion Date
November 2008 (final data collection date for primary outcome measure)
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
-ther 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.
Gender
Both
Ages
18 Years and older
Accepts Healthy Volunteers
No
Contacts 
Location Countries 
Expanded Access Status
Administrative Information
NCT ID 
NCT00089895
Responsible Party
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Secondary IDs 
Study Sponsor 
Schering-Plough
Collaborators 
Duke University
Investigators 
Information Provided By
Schering-Plough
Verification Date
December 2008
 Required WHO trial registration data element.
 WHO trial registration data element that is required only if it exists.