Status:
COMPLETED
Intravenous Versus Intracoronary Use of Abciximab
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Atherosclerosis
Ischemic Heart Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The aim of this study is to investigate wether intracoronary use of bolus Abciximab is superior to intravenous bolus in patients undergoing percutaneous coronary intervention.
Detailed Description
STEMI patients with indication for adjuvant therapy with GPI during pPCI, and who gave informed consent, were randomized, using sealed, opaque envelopes, to either IC or IV bolus (0.25 mg/kg body weig...
Eligibility Criteria
Inclusion
- Usually inclusion criteria for Abciximab, that is:
- Adjunct to PCI for the prevention of cardiac ischemic complications:
- In patients undergoing PCI
- In patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours
Exclusion
- Usually exclusion criteria for Abciximab, that is:
- Active internal bleeding, recent (within 6 weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
- History of cerebrovascular accident (CVA) within 2 years, or CVA with a significant residual neurological deficit
- Bleeding diathesis
- Administration of oral anticoagulants within 7 days unless prothrombin time is less than or equal to 1.2 times control, thrombocytopenia (\<100,000 cells/µL)
- Recent (within 6 weeks) major surgery or trauma
- Intracranial neoplasm
- Arteriovenous malformation, or aneurysm
- Severe uncontrolled hypertension
- Presumed or documented history of vasculitis
- Use of intravenous dextran before percutaneous coronary intervention, or intent to use it during intervention
- Known hypersensitivity to any component of this product or to murine proteins.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00685464
Start Date
January 1 2006
End Date
December 1 2009
Last Update
August 10 2011
Active Locations (1)
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1
Dept. of Cardiology, Gentofte University Hospital
Hellerup, Denmark, 2900