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| Sponsor: | Deutsches Herzzentrum Muenchen |
|---|---|
| Information provided by: | Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00373451 |
Purpose
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 complications in patients suffering from a heart attack and undergoing coronary intervention.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Coronary Disease |
Drug: Abciximab + UFH Drug: Bivalirudin Drug: Heparin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Abciximab And Bivalirudin in Patients With Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Interventions (ISAR-REACT-4) |
| Estimated Enrollment: | 1700 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Abciximab+UFH
Abciximab and unfractionated heparin as bolus given during PCI and abciximab-perfusion for 12 hours after PCI
|
Drug: Abciximab + UFH
Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute [maximum of 10 µg/minute] infusion for 12 hours)
Other Name: ReoPro
Drug: Heparin
i.v. bolus of 70 units/kg/body weight of unfractionated heparin
Other Name: unfractionated heparin
|
|
Active Comparator: Bivalirudin
Bivalirudin given only during PCI
|
Drug: Bivalirudin
Bivalirudin (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: Angiox
|
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 NSTEMI is characterized by a disrupted atherosclerotic plaque, platelet activation and aggregation, thrombus formation and microembolizations. Patients with NSTEMI are treated with an early invasive strategy and there is intensive work in progress to define the optimal antithrombotic therapy to be used in adjunct to percutaneous coronary intervention (PCI) in these patients. Bivalirudin, a direct thrombin inhibitor, and the glycoprotein IIb/IIIa inhibitor (GPI) abciximab have been in the focus of recent trials in patients with acute coronary syndrome (ACS). In a recent randomized, open-label trial (ACUITY trial), patients with the suspicion of ACS on the basis of the type of anginal symptoms, ST-segment displacement, elevated biomarkers or several risk indicators were randomized to receive bivalirudin alone with bail-out GPIs, bivalirudin plus GPIs, or heparin/low-molecular weight heparin plus a GPI. The GPIs most frequently used were eptifibatide and tirofiban. Abciximab was given in only < 9% of the cases. In another randomized, double-blind, placebo-controlled trial (ISAR-REACT-2) including ACS patients undergoing PCI, abciximab was administered in cath lab and was associated with a significant reduction of ischemic events in patients with NSTEMI, and did not lead to a measurable increase in major bleeding complications. However, it is not known whether abciximab is also superior to bivalirudin in patients with NSTEMI. We designed this study to assess whether abciximab added to unfractionated heparin is superior to bivalirudin in patients with NSTEMI.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Herz-Zentrum Bad Krozingen | |
| Bad Krozingen, Germany, 79189 | |
| Herz- und Gefaessklinik, Kardiologie | |
| Bad Neustadt, Germany, 97616 | |
| Vivantes Klinikum Neukoelln | |
| Berlin, Germany, 12351 | |
| Vivantes Klinikum im Friedrichshain | |
| Berlin, Germany, 10249 | |
| Vivantes Auguste Viktoria Klinikum | |
| Berlin, Germany, 12157 | |
| Medizinische Klinik, Klinikum rechts der Isar | |
| Muenchen, Germany, 81675 | |
| Deutsches Herzzentrum Muenchen | |
| Munich, Germany, 80636 | |
| Marienhospital Osnabrueck | |
| Osnabrueck, Germany, 49074 | |
| Italy | |
| Ospedale Cageggi | |
| Firenze, Italy, 50134 | |
| Study Chair: | Albert Schoemig, MD | Deutsches Herzzentrum Muenchen |
| Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
More Information
| Responsible Party: | Prof. A. Schömig, Deutsches Herzzentrum Munich |
| ClinicalTrials.gov Identifier: | NCT00373451 History of Changes |
| Other Study ID Numbers: | GE IDE No. A01106 |
| Study First Received: | September 7, 2006 |
| Last Updated: | April 12, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
NSTEMI |
|
Coronary Disease Coronary Artery Disease Infarction Myocardial Infarction Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Ischemia Pathologic Processes Necrosis Angina Pectoris |
Chest Pain Pain Signs and Symptoms Calcium heparin Bivalirudin Abciximab Heparin Hirudins Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
