Phase 3
Completed N=9,406
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Source: ClinicalTrials.gov NCT00089895 ↗Enrolled (actual)
9,406
Serious AEs
1.4%
Results posted
Dec 2009
Primary outcomePrimary: Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. — 9.3; 10.0 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. |
9.3; 10.0 | — |
| SECONDARY Incidence of the Composite of Death/MI. |
11.2; 12.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00089895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.