Clinical trial NCT00326976: Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
Official title: A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Measure the Effect of FX06 (a Fibrin Derived Peptide Bbeta15-42) on Ischemia Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention (PCI): The "F.I.R.E." Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Myocardial Revascularization
Lead sponsor: Fibrex Medical Research & Development GmbH
Sponsor class: INDUSTRY
First posted: 2006-05-17
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent
* 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:

* History of MI (from patient history, or from ECG)
* 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.

Primary outcomes:
measure: Infarct size as measured by cardiac MRI
timeFrame: 5-7 days post intervention
Secondary outcomes:
measure: Myocardial scar mass and left ventricular function
timeFrame: 4 months post intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Vienna
country: Austria
facility: Wilhelminen-Spital
city: Brussels
country: Belgium
facility: Academisch Ziekenhuis van de vrije Universiteit
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Hradec Kralove
country: Czech Republic
facility: I. Interna Klinika, Fakultni nemocnice Hradec Kralove
city: Usti nad Labem
country: Czech Republic
facility: Kardiologicke oddeleni, Masarykova nemocnice
city: Hellerup
country: Denmark
facility: Amtssygehuset i Gentofte
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bad Berka
country: Germany
facility: Zentralkliniken Bad Berka
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln, Klinik für Innere Medizin
city: Bernau
country: Germany
facility: Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
city: Düren
country: Germany
facility: Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg - Innere Medizin III
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I
city: Halle
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie
city: Leipzig
country: Germany
facility: Universität Leipzig, Klinik für Innere Medizin, Herzzentrum
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim, I. Medizinische Klinik
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Osnabrück
country: Germany
facility: Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Lodz
country: Poland
facility: Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego
city: Lodz
country: Poland
facility: Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga
city: Timisoara
country: Romania
facility: Institute for Cardiovascular Disease
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linkoeping
country: Sweden
facility: Universitetssjukhuset
city: Zurich
country: Switzerland
facility: Universitätshospital Zürich
Study officials:
affiliation: Aker University Hospital, Oslo, Norway
name: Dan Atar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.