Phase 3
N=9,406
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Myocardial Ischemia · Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00089895 ↗Enrolled (actual)
9,406
Serious AEs
1.4%
Results posted
Dec 2009
Primary outcome: 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 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eptifibatide (Integrilin) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Nov 2008
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 | — |
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).
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.