Status:
COMPLETED
Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Schering-Plough
Medtronic
Conditions:
Myocardial Infarction
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Rationale: ST-elevation myocardial infarction (STEMI) is usually triggered by rupture of an atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive coronary thromb...
Eligibility Criteria
Inclusion
- Ischemic chest discomfort of 30 minutes duration
- Onset of chest pain 12 hours prior to entry into the study
- ST segment elevation of \> 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead electrocardiogram \[ECG\]), or left bundle branch block not known to be old
Exclusion
- Active bleeding
- History of stroke within 90 days or any intracranial bleed.
- Major surgery or trauma within the past 6 weeks
- Uncontrolled hypertension (systolic blood pressure \[SBP\] 200 mm Hg and/or diastolic blood pressure \[DBP\] 110 mm Hg despite treatment)
- Prolonged (\> 10 minutes) cardiopulmonary resuscitation
- Inadequate vascular access
- PCI within the last 30 days
- Thrombolytic agents within the preceding 7 days
- Concurrent use of warfarin
- A blood coagulation disorder (i.e. international normalized ratio \[INR\] \> 2.0, platelet count \< 100,000/mm3, or hematocrit \< 30%)
- Intolerance to aspirin or clopidogrel
- A subcutaneous therapeutic dose of any low molecular weight heparin (LMWH) within 12 hours
- Known severe contrast allergy
- Other medical condition that is likely to result in death within 12 months
- Participation in a study or another investigational device or drug trial within the past four weeks
- Pregnancy
- Known severe renal impairment (creatinine \> 200 mole/l)
- Sustained hypotension, systolic blood pressure \< 80 mm Hg, or the need for intravenous (IV) inotropes and/or intraaortic balloon counterpulsation to support the blood pressure
- Inability to provide informed consent
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00251823
Start Date
July 1 2005
End Date
September 1 2008
Last Update
September 4 2008
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7