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. [Time Frame: 96 hours after randomization] [Designated as safety issue: No]

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. [Time Frame: 30 days after randomization] [Designated as safety issue: No] Incidences of (1) MI and (2) the composite of death/MI. [Time Frame: 96 hours after randomization] [Designated as safety issue: No] Incidence of the composite of death/MI/RI-UR [Time Frame: 30 days after randomization] [Designated as safety issue: No] Incidence of death. [Time Frame: 30 days, 6 months, and 1 year after randomization] [Designated as safety issue: No]

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 † 9500

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 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.

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.