EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Duke Clinical Research Institute
• Treatments: Dalteparin; Eptifibatide; Heparin, Low-Molecular-Weight; Krestin

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.