Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)
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|ClinicalTrials.gov Identifier: NCT00262054|
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : March 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Angina Pectoris||Drug: Bivalirudin Drug: Un-fractionated heparin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4570 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||May 2008|
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.
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.
Other Name: ReoPro
Active Comparator: B
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.
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.
- Composite rate of death, myocardial infarction (MI),urgent target vessel revascularization (TVR) within 30 days or in-hospital major bleeding [ Time Frame: 30 days ]
- Composite rate of death, MI or urgent TVR within 30 days [ Time Frame: 30 days ]
- Composite rate of death, MI or TVR at 1 year [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262054
|Bad Krozingen, Germany, 79189|
|Bad Segeberg, Germany, 23795|
|Deutsches Herzzentrum Muenchen|
|Munich, Germany, 80636|
|First Medizinische Klinik, Klinikum rechts der Isar|
|Munich, Germany, 81675|
|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|