Status:
COMPLETED
Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Technical University of Munich
Conditions:
Coronary Disease
Angina, Unstable
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syn...
Detailed Description
Although percutaneous coronary interventions (PCIs) are an established therapeutic approach in patients presenting with acute coronary syndrome (ACS), it is still unclear which the best antithrombotic...
Eligibility Criteria
Inclusion
- Patients with acute coronary syndromes
- Pretreatment (2 hours) with high loading dose (600 mg) clopidogrel
- Significant angiographic lesions amenable to and requiring a PCI
- Written informed consent
Exclusion
- ST-segment elevation acute myocardial infarction within 48 hours from symptom onset
- Hemodynamic instability
- Pericarditis
- Malignancies with life expectancy less than one year
- Increased risk of bleeding
- Oral anticoagulation therapy with coumarin derivative within 7 days
- Recent use of GPIIb/IIIa inhibitors within 14 days
- Severe uncontrolled hypertension \>180 mmHg unresponsive to therapy
- Relevant hematologic deviations: hemoglobin \< 100g/L or hematocrit \< 34%; platelet count \< 100 x 10\^9/L or platelet count \> 600 x 10\^9/L.
- Known allergy to the study medication
- Pregnancy (present or suspected)
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
2022 Patients enrolled
Trial Details
Trial ID
NCT00133003
Start Date
March 1 2003
End Date
January 1 2006
Last Update
April 15 2008
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 500-04012180
2
Herz-Zentrum
Bad Krozingen, Germany, 79189
3
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
4
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675