Status:
COMPLETED
Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Myocardial Infarction
Coronary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine which of these anti-clotting medications, abciximab plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and bleeding complicat...
Detailed Description
Non-ST elevation myocardial infarction (NSTEMI) is associated with an increased risk of death and is a major reason for hospital admissions. Most frequently, the sequence of events that leads to NSTEM...
Eligibility Criteria
Inclusion
- Episode of unstable angina
- Elevated cardiac markers
- Angiographic lesions requiring PCI
- Informed, written consent
Exclusion
- Age \< 18 years and \> 80 years
- ST-segment elevation acute myocardial infarction within 48 hours
- Cardiogenic shock
- Pericarditis
- Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance
- Active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; pericarditis; and patient's refusal to blood transfusion
- Oral anticoagulation therapy with coumarin derivative within the last 7 days
- Recent use of GPIIb/IIIa inhibitors within 14 days
- Treatment with unfractionated heparin within 4 hours unless ACT \> 150sec; or low-molecular weight heparin within 8 hours before randomization
- Treatment with bivalirudin within 24 hours before randomization
- Severe uncontrolled hypertension \> 180/110 mm Hg unresponsive to therapy
- Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days
- Relevant hematologic deviations
- Glomerular filtration rate (GFR) \< 30 ml/min or serum creatinine \> 30 mg/L or dependence on renal dialysis
- Known allergy or intolerance to the study medications, stainless steel or true anaphylaxis after prior exposure to contrast media
- Previous enrollment in this trial
- Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
- Patient's inability to fully cooperate with the study protocol
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1721 Patients enrolled
Trial Details
Trial ID
NCT00373451
Start Date
July 1 2006
End Date
July 1 2011
Last Update
May 8 2012
Active Locations (9)
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1
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
2
Herz- und Gefaessklinik, Kardiologie
Bad Neustadt an der Saale, Germany, 97616
3
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
4
Vivantes Auguste Viktoria Klinikum
Berlin, Germany, 12157