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Sponsored by: |
Deutsches Herzzentrum Muenchen |
Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00262054 |
The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
Condition | Intervention | Phase |
Coronary Disease Angina Pectoris |
Drug: Bivalirudin Drug: Un-fractionated heparin |
Phase IV |
MedlinePlus related topics: | Angina Blood Thinners |
Drug Information available for: | Heparin Abciximab Bivalirudin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Bivalirudin and Un-Fractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions. ISAR-REACT-3 |
Enrollment: | 4570 |
Study Start Date: | November 2005 |
Study Completion Date: | May 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
bivalirudin is to be administered as an intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.
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Drug: Bivalirudin
bivalirudin to be administered as an intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.
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B: Active Comparator
UFH given as an intravenous bolus of 140 units/kg. Double blinding will be maintained by using a double-dummy technique consisting of identical UFH and bivalirudin syringes and bivalirudin or placebo infusion bags.
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Drug: Un-fractionated heparin
UFH is given as an intravenous bolus of 140 units/kg followed by infusion of placebo 1.75 mg/kg per hour for the duration of the procedure.
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Thrombin plays a major role in acute coronary artery occlusions during percutaneous coronary interventions. Unfractionated heparin has been traditionally used during invasive coronary procedures to reduce the risk of thrombotic occlusion. Bivalirudin, a direct antithrombin inhibitor, has several advantages over unfractionated heparin: it acts independently of antithrombin and inhibits both free and clot-bound thrombin; it is not neutralized by circulating inhibitors; exhibits consistent dose-response characteristics, and does not cause thrombocytopenia. Previous studies have shown that use of bivalirudin among patients undergoing percutaneous coronary interventions is associated with better outcomes (death, myocardial infarction, urgent repeat revascularization or in-hospital major bleeding) as compared with unfractionated heparin and adjunctive use of glycoprotein IIb/IIIa platelet receptor inhibitors. However, previous studies have included patients treated with plain balloon angioplasty or stenting after inadequate pre-treatment with thienopyridines (ticlopidine or clopidogrel). Recent guidelines recommend that all patients undergoing percutaneous coronary interventions must receive a loading dose of 300 -600 mg of clopidogrel. A 600 mg loading dose of clopidogrel eliminates the need for glycoprotein IIb/IIIa platelet receptor inhibitors in adjunct to heparin. According to existing evidence antithrombotic regimens based on either bivalirudin or pre-treatment with 600 mg of clopidogrel in addition to UFH intraprocedurally, are effective strategies to reduce ischemic and hemorrhagic complications in patients with coronary artery disease undergoing PCI. At present, it is not known whether bivalirudin is superior to UHF in patients who have been optimally pre-treated with a loading dose of clopidogrel.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Deutsches Herzzentrum Muenchen | |||||
Munich, Germany, 80636 | |||||
First Medizinische Klinik, Klinikum rechts der Isar | |||||
Munich, Germany, 81675 | |||||
Herz-Zentrum | |||||
Bad Krozingen, Germany, 79189 | |||||
Segeberger Kliniken | |||||
Bad Segeberg, Germany, 23795 |
Deutsches Herzzentrum Muenchen |
Study Chair: | Albert Schomig, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
Study Director: | Franz-Josef Neumann, MD | Herz-Zentrum Bad Krozingen |
Responsible Party: | Deutsches Herzzentrum Munich ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. A01005, KKF 1.1-05 |
First Received: | December 5, 2005 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00262054 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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