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Sponsors and Collaborators: |
University of Leipzig Corodination Center for Clinical Trials Leipzig Lilly Germany GmbH |
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Information provided by: | University of Leipzig |
ClinicalTrials.gov Identifier: | NCT00712101 |
To examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure
Condition | Intervention | Phase |
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ST-Elevation Myocardial Infarction |
Drug: abciximab intracoronary Drug: abciximab intravenously |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Randomized Controlled Clinical Study to Compare Abciximab-Bolus i.v. Versus i.c. in Primary PCI in Patients With Acute ST-Elevation Myocardial Infarction |
Estimated Enrollment: | 1868 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Abciximab bolus administration intracoronary
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Drug: abciximab intracoronary
administer abciximab bolus intracoronary during primary percutaneous coronary intervention
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2: Active Comparator
Abciximab bolus intravenously
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Drug: abciximab intravenously
administer abciximab bolus intravenously during primary percutaneous coronary intervention
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In patients with acute ST-elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI) is the preferred reperfusion regimen, if performed by experienced operators in a timely manner. Nevertheless, myocardial damage is not immediately terminated after successful epicardial reperfusion by primary PCI. Current strategies are directed to improve myocardial tissue perfusion, which is impaired in approximately 50% of patients and which has prognostic impact. Adjunctive intravenous abciximab administration is an established therapy to improve coronary microcirculation and reduce major cardiac adverse events.5-10 In randomized clinical trials intravenous abciximab administration has been studied. Clinical trials have shown that earlier administration results in higher preinterventional TIMI-flow with subsequent improved perfusion post PCI. However, in a pooled analysis there was no effect on mortality. As door-to-balloon-times getting shorter in current trials, earlier abciximab administration requires treatment in the prehospital setting, which poses substantial logistic obstacles. Another option might be intracoronary abciximab bolus administration which results in very high local platelet inhibitor concentrations. This might be favorable in dissolution of thrombi and microemboli with subsequent improved myocardial microcirculation, reduction of no-reflow, and infarct size. Currently, there is only limited clinical experience on the efficacy of intracoronary abciximab administration mainly restricted to case reports, retrospective registries or small randomized trials. In a recently published randomized clinical trial, we were able to show that intracoronary versus intravenous abciximab bolus administration has beneficial effects on the occurrence of no-reflow and infarct size assessed by contrast-enhancement magnetic resonance imaging. This led to a trend towards improved clinical outcome. The composite major adverse cardiac event rate, defined as death, reinfarction, target vessel revascularization, and new congestive heart failure, at 30 day follow-up was 15.6% after intravenous and 5.2% after intracoronary abciximab administration (relative risk 3.00; 95% confidence intervals 0.94-10.80; p=0.06).
Currently, there is no adequately powered clinical trial to assess the effects of intracoronary bolus in comparison to standard intravenous abciximab administration. Due to its general availability and its ease of intracoronary administration this treatment has overwhelming potential in clinical practice, which is much easier to achieve than a logistically cumbersome prehospital or interhospital transfer administration.
In the era of evidence-based medicine, such a trial is of paramount importance to achieve a break-through in abciximab use and a reduction of the high associated morbidity and mortality of STEMI patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical symptoms:
ECG-criteria for ST-elevation myocardial infarction in 12-lead ECG:
Exclusion Criteria:
Contact: Holger Thiele, MD, PhD | +49 341 8651426 | thielh@medizin.uni-leipzig.de |
Contact: Petra Neuhaus, PhD | + 49 341 9716255 | petra.neuhaus@kksl.uni-leipzig.de |
Germany | |
University of Leipzig - Heart Center | Recruiting |
Leipzig, Germany, 04289 | |
Contact: Holger Thiele, MD 0049 3418651426 thielh@medizin.uni-leipzig.de | |
Contact: Anja Leuschner 0049 3418651426 anja.leuschner@med.uni-leipzig.de | |
Principal Investigator: Holger Thiele, MD | |
Jochen Wöhrle | Recruiting |
Ulm, Germany, 89081 | |
Contact: Jochen Wöhrle, MD 0049 731-500-45001 jochen.woehrle@uniklinik-ulm.de | |
Principal Investigator: Jochen Wöhrle, MD | |
Herz- und Gefäß-KLinik Bad Neustadt | Recruiting |
Bad Neustadt, Germany, 97616 | |
Contact: Sebastian Kerber, MD +49 9771 662302 kerber@kardiologie-bad-neustadt.de | |
Principal Investigator: Sebastian Kerber, MD | |
Klinikum Coburg | Recruiting |
Coburg, Germany, 96450 | |
Contact: Harald Rittger, MD +49 9561 22-33215 harald.rittger@klinikum-coburg.de | |
Principal Investigator: Harald Rittger, MD | |
Herz und Diabeteszentrum Bad Oeynhausen | Recruiting |
Bad Oeynhausen, Germany, 32545 | |
Contact: Marcus Wiemer, MD +49 5731 97 1248 mwiemer@hdz-nrw.de | |
Principal Investigator: Marcus Wiemer, MD | |
Klinikum Pirna | Recruiting |
Pirna, Germany, 01796 | |
Contact: Christoph Axthelm, MD +49 3501766 -1526 c.axthelm.kard@klinikum-pirna.de | |
Principal Investigator: Christoph Axthelm, MD |
Study Chair: | Holger Thiele, MD, PhD | University of Leipzig |
Study Director: | Gerhard Schuler, MD, PhD | University of Leipzig |
Principal Investigator: | Jochen Woehrle, MD, PhD | University of Ulm |
Responsible Party: | University of Leipzig - Heart Center ( Dr. Holger Thiele ) |
Study ID Numbers: | Final version 1.1 |
Study First Received: | July 3, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00712101 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
infarction intervention stent abciximab platelets |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Abciximab Ischemia Infarction Myocardial Infarction |
Anticoagulants Pathologic Processes Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |