Status:
COMPLETED
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Duke Clinical Research Institute
Conditions:
Myocardial Ischemia
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
9406 Patients enrolled
Trial Details
Trial ID
NCT00089895
Start Date
November 1 2004
End Date
November 1 2008
Last Update
May 17 2024
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