Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
NCT ID: NCT00326976
Last Updated: 2007-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2006-08-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
400 mg injected in 2 divided boluses
FX06
400 mg as intravenous injection in two divided boluses
Percutaneous coronary intervention
2
Matching placebo
FX06
400 mg as intravenous injection in two divided boluses
Percutaneous coronary intervention
Interventions
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FX06
400 mg as intravenous injection in two divided boluses
Percutaneous coronary intervention
Eligibility Criteria
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Inclusion Criteria
* Patients after primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI)
* Men or women with no child bearing potential
* Onset of symptoms to balloon time \< 6 hours
* ST-elevation of at least 2 mm in at least 3 leads on 12-lead electrocardiogram (ECG)
* Primary PCI indicated per standard of care
* First myocardial infarction (MI)
* Single index lesion with complete occlusion \[thrombolysis in myocardial infarction (TIMI) flow 0/I\] of one target vessel.
Exclusion Criteria
* Chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the acute myocardial infarction (AMI)
* Need for coronary artery bypass graft (CABG)
* Administration of any thrombolytic agent since onset of AMI symptoms
* Serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, LM dissection, etc.)
* Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents
* Contraindication to cardiovascular magnetic resonance (CMR): claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; frequent extrasystoles (\> 12/Min) or atrial fibrillation (AF).
* Known renal dysfunction defined as serum creatinine \> 250 µmol/l
* Previous CABG
* History of congestive heart failure (CHF)
* Body mass index (BMI) \> 35
* Patients who cannot communicate reliably with the investigator
* Patients who are unlikely to cooperate with the requirements of the study
* Patients who are unwilling and/or unable to give informed consent
* Patients at increased risk of death from a pre-existing concurrent illness
* Patients participating in another clinical study
* Patients who have used any other investigational drugs within 1 month of first dosing
* Patients who have participated already in this study
* Patients who are employees at the investigational site; relatives or spouse of the investigator.
18 Years
80 Years
ALL
No
Sponsors
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Fibrex Medical Research & Development GmbH
INDUSTRY
Responsible Party
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Fibrex Medical Research & Development GmbH
Principal Investigators
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Dan Atar, MD
Role: PRINCIPAL_INVESTIGATOR
Aker University Hospital, Oslo, Norway
Locations
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Allgemeines Krankenhaus Wien
Vienna, , Austria
Wilhelminen-Spital
Vienna, , Austria
Academisch Ziekenhuis van de vrije Universiteit
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
I. Interna Klinika, Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Kardiologicke oddeleni, Masarykova nemocnice
Ústí nad Labem, , Czechia
Amtssygehuset i Gentofte
Hellerup, , Denmark
Universitätsklinikum Aachen
Aachen, , Germany
Zentralkliniken Bad Berka
Bad Berka, , Germany
Charite, Campus Benjamin Franklin
Berlin, , Germany
Vivantes Klinikum Neukölln, Klinik für Innere Medizin
Berlin, , Germany
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
Bernau, , Germany
Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)
Düren, , Germany
Universitätsklinikum Freiburg - Innere Medizin III
Freiburg im Breisgau, , Germany
Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I
Halle, , Germany
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III
Halle, , Germany
Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie
Kiel, , Germany
Universität Leipzig, Klinik für Innere Medizin, Herzzentrum
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck
Lübeck, , Germany
Universitätsklinikum Mannheim, I. Medizinische Klinik
Mannheim, , Germany
Deutsches Herzzentrum München
Munich, , Germany
Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
Osnabrück, , Germany
Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology
Vilnius, , Lithuania
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego
Lodz, , Poland
Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga
Lodz, , Poland
Institute for Cardiovascular Disease
Timișoara, , Romania
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Universitetssjukhuset
Linköping, , Sweden
Universitätshospital Zürich
Zurich, , Switzerland
Countries
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References
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Hallen J, Jensen JK, Fagerland MW, Jaffe AS, Atar D. Cardiac troponin I for the prediction of functional recovery and left ventricular remodelling following primary percutaneous coronary intervention for ST-elevation myocardial infarction. Heart. 2010 Dec;96(23):1892-7. doi: 10.1136/hrt.2009.190819.
Hallen J, Petzelbauer P, Schwitter J, Geudelin B, Buser P, Atar D. Impact of time to therapy and presence of collaterals on the efficacy of FX06 in acute ST elevation myocardial infarction: a substudy of the F.I.R.E., the Efficacy of FX06 in the prevention of myocardial reperfusion injury trial. EuroIntervention. 2010 Apr;5(8):946-52.
Atar D, Petzelbauer P, Schwitter J, Huber K, Rensing B, Kasprzak JD, Butter C, Grip L, Hansen PR, Suselbeck T, Clemmensen PM, Marin-Galiano M, Geudelin B, Buser PT; F.I.R.E. Investigators. Effect of intravenous FX06 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction results of the F.I.R.E. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury) trial. J Am Coll Cardiol. 2009 Feb 24;53(8):720-9. doi: 10.1016/j.jacc.2008.12.017.
Other Identifiers
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FX06AQ-II-01
Identifier Type: -
Identifier Source: org_study_id