Status:
UNKNOWN
Comparison of Intracoronary Versus Intravenous Abciximab in ST-segment Elevation Myocardial Infarction (CICERO)
Lead Sponsor:
University Medical Center Groningen
Conditions:
ST-Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patie...
Detailed Description
The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, how...
Eligibility Criteria
Inclusion
- a diagnosis of STEMI defined by
- chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
- time from onset of symptoms of less than 12 hours
- ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
Exclusion
- rescue PCI after thrombolytic therapy
- need for emergency coronary artery bypass grafting
- presence of cardiogenic shock
- known existence of a life-threatening disease with a life expectancy of less than 6 months
- inability to provide informed consent
- contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT00927615
Start Date
September 1 2008
End Date
April 1 2011
Last Update
September 8 2010
Active Locations (1)
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1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9713 GZ