Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Deutsches Herzzentrum Muenchen Technische Universität München |
---|---|
Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00133250 |
The purpose of this study is to assess whether abciximab is associated with additional benefit in patients with AMI treated with PCI after high dose clopidogrel loading.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Drug: Abciximab Other: Placebo Heparin Sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3) |
Enrollment: | 800 |
Study Start Date: | June 2003 |
Study Completion Date: | March 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Abciximab
|
Drug: Abciximab
Abciximab bolus and infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 10 mg abciximab. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
|
B: Placebo Comparator
Heparin Sodium
|
Other: Placebo Heparin Sodium
Placebo bolus plus infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 3000 U Heparin. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
|
The goal of all reperfusion therapies in acute myocardial infarction (AMI) is an effective restoration of coronary blood flow and the reduction of infarct size. Recently, the researchers were able to achieve excellent results with primary stenting plus abciximab in terms of reduction of infarct size and improvement of clinical outcome in the STOPAMI trial. This strategy provided a clear benefit compared to fibrinolysis. On the basis of the data published in the last 2 years, hospitals without angioplasty facilities have now better possibilities to improve the results of primary treatment of patients with AMI by immediately referring these patients to highly experienced centers in coronary interventions. There is an increasing interest to assess the additional advantages of pharmacologic reperfusion approaches which are readily applicable in the time window between presentation and arrival at the catheterization room. Two studies have shown that the results of the PCI in patients with AMI pretreated with fibrinolysis may even be more unfavorable than those achieved with angioplasty alone. Glycoprotein (GP) IIb/IIIa blocker abciximab has been shown to improve the results of the primary PCI in AMI. However, no rapidly effective antiplatelets therapy was available at the time when the studies on the benefit of abciximab were performed. Recent studies have shown that a high, 600 mg loading dose of clopidogrel is significantly more rapidly acting and that maximal inhibition of platelet aggregation is achieved within 2 hours after administration. In the ISAR-REACT trial, a high loading dose of clopidogrel was well tolerated, associated with such a low frequency of procedural complications that the use of abciximab offered no clinically measurable benefit at 30 days.
Comparison:
Abciximab (bolus+infusion for 12h) versus Placebo (bolus+infusion for 12h) after pre-treatment with 600 mg clopidogrel.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Allgemeines Krankenhaus Wien | |
Vienna, Austria, 1090 | |
Germany | |
Deutsches Herzzentrum Muenchen | |
Munich, Germany, 80636 | |
First Medizinische Klinik, Klinikum rechts der Isar | |
Munich, Germany, 81675 | |
Klinikum Traunstein | |
Traunstein, Germany, 83278 | |
Klinikum Garmisch-Partenkirchen | |
Garmisch-Partenkirchen, Germany, 82467 |
Study Chair: | Albert Schomig, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
Responsible Party: | Deutsches Herzzentrum Muenchen ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. I00902 |
Study First Received: | August 20, 2005 |
Last Updated: | June 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00133250 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Calcium, Dietary Necrosis Heart Diseases Clopidogrel Myocardial Ischemia Vascular Diseases |
Abciximab Ischemia Infarction Heparin Myocardial Infarction Calcium heparin |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |