Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326976
• Other study ID #: FX06AQ-II-01
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2006
• Last updated: December 3, 2007
• Start date: August 2006
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: Fibrex Medical Research & Development GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentAustria: Federal Ministry for Health and WomenNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Swedish National Council on Medical EthicsSwitzerland: SwissmedicCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyPoland: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Drug:
• FX06
400 mg as intravenous injection in two divided boluses

Procedure:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus Wien	Vienna
Austria	Wilhelminen-Spital	Vienna
Belgium	Academisch Ziekenhuis van de vrije Universiteit	Brussels
Belgium	Cliniques Universitaires St-Luc	Brussels
Czech Republic	I. Interna Klinika, Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czech Republic	Kardiologicke oddeleni, Masarykova nemocnice	Usti nad Labem
Denmark	Amtssygehuset i Gentofte	Hellerup
Germany	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
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
Lithuania	Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology	Vilnius
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow
Poland	Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga	Lodz
Poland	Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego	Lodz
Romania	Institute for Cardiovascular Disease	Timisoara
Sweden	Sahlgrenska Universitetssjukhuset	Gothenburg
Sweden	Universitetssjukhuset	Linkoeping
Switzerland	Universitätshospital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Fibrex Medical Research & Development GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Denmark,  Germany,  Lithuania,  Netherlands,  Poland,  Romania,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size as measured by cardiac MRI		5-7 days post intervention	No
Secondary	Myocardial scar mass and left ventricular function		4 months post intervention	No