Patients who present with high-risk non-ST-segment elevation acute coronary syndrome who are planned to undergo an invasive strategy no sooner than the next calendar day following randomization. MedDRA version: 6.0 Level: PT Classification code 10051592
Conditions
Interventions
Trade Name: Integrilin 0.75 mg/ml Solution for Infusion
Product Name: Integrilin 0.75mg/ml solution for infusion
Pharmaceutical Form: Solution for infusion
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older. 2. Willing and able to give informed consent. The patient must be able to comply with study procedures and follow-up through 1 year 3. Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes within 24 hours of randomization and have at least 2 of the following: - Electrocardiogram (ECG) changes: • New or presumable new ST-segment depression > or =0.1 mV or transient ( or = 0.1mV in at least 2 contiguous leads - Elevated troponin I or T greater than the established criteria at site or creatine kinase-MB fraction (CK-MB) greater than the site's upper limit of normal (ULN) - 60 years of age or older. Or have all 3 of the following: - Prior history of cardiovascular disease [eg, prior MI, PCI, CABG, >50% coronary artery stenosis by angiography, ischemia present on exercise-stress imaging pharmacologic-stress imaging study, peripheral vascular disease (PVD) with symptoms and objective evidence (eg, ankle brachial index (ABI) >= 0.9), non-hemorrhagic cerebrovascular accident (CVA)] - Elevated troponin I or T greater than the established criteria at each site or CK-MB greater than the site's ULN - 50-59 years of age 4. Able to be randomized within 12 hours of presentation. 5. Plan to undergo an invasive strategy after administration of study drug for 12 to 96 hours. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy-known or suspected-premenopausal females must have a confirmed negative urine or serum pregnancy test before study enrolment 2. Renal dialysis within 30 days prior to randomization 3. Other serious illness (eg, active cancer within 5 years, sepsis) or any condition that the investigator feels would pose a significiant hazard to the patient if the investigational therapy was to be initiated. 4. History of a hemorrhagic stroke at any time or non-hemorrhagic stroke of any etiology within 7 days; central nervous system structural damage (eg, neoplasm, aneurysm, intracranial surgery);any recent severe head or facial trauma. 5. History of a bleeding diathesis, including documented gastrointestinal (GI) bleeding or any history of clinically significant GI bleeding, or evidence of active abnormal bleeding within 30 days prior to randomization or an international normalized ratio (INR) >1.8 due to treatment with an oral anticoagulant or underlying coagulopathy. 6. Major surgery, biopsy of a parenchymal organ, or significant trauma within 14 days prior to randomization 7. History of heparin or eptifibatide induced thrombocytopenia or a platelet count of <100,000 mm3. Platelet count should be confirmed by drawing a second blood sample. 8. Intent to use a direct thrombin inhibitor (other than bivalirudin [Angiomax]), factor Xa inhibitor (e.g. fondaparinux [Arixtra], or any other anticoagulant other than UFH or low molecular weight heparin in accordance with local standard of care. (Exception: warfarin after completion of study drug infusion is permitted in patients with an indication for oral anticoagulation). 9. Recent therapy with a GP IIB/IIIa inhibitor; abciximab within 24 hours prior to randomization, or eptifibatide, tirofiban, or other agent within 4 hours prior to randomization. 10 Known hypersensitivity to any component of the products evaluated in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of early eptifibatide, administered as a double bolus plus infusion, compared to placebo (with provisional use of eptifibatide in the catheterization laboratory) in reducing the composite of death, myocardial infarction (MI), recurrent ischemia requiring urgent revascularization (RI-UR), and thrombotic bail-out (TBO) within 96 hours of randomization in patients with high-risk non-ST-segment elevation acute coronary syndrome (NSTE ACS) who are planned to be managed with an invasive strategy after receiving study drug for 12 to 96 hours.; Secondary Objective: The secondary objectives are to demonstrate the superiority of early eptifibatide use compared to placebo (with provisional use of eptifibatide in the catherization laboratory) in this setting, in reducing the following: - The composite of death and MI within 30 days - The composite of death, MI and RI-UR within 30 days - The composite of death and MI within 96 hours - The occurrence of MI within 96 hours - The occurrence of death within 30 days Additionally the occurrence of death at 6 months and 1 year will be examined. ; Primary end point(s): Safety: All serious adverse events will be monitored from randomization through the 30-day follow-up contact. In addition clinical events and 2 key safety endpoints (for the patients who undergo CABG surgery), post-operative bleeding volume and the occurrence of surgical re-exporation, will be assessed. Mortality will be monitored for one year after randomization. Efficacy: The primary efficacy endpoint is the composite of death, MI RI-UR, and TBO within 96 hours. The key secondary endpoint is the composite of death and MI within 30 days. All components of the efficacy endpoints except death will be a | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, Hungary, Italy, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed