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Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Primary Purpose

Myocardial Ischemia, Coronary Disease, Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FX06
Percutaneous coronary intervention
Sponsored by
Fibrex Medical Research & Development GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Revascularization

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allgemeines Krankenhaus Wien
  • Wilhelminen-Spital
  • Academisch Ziekenhuis van de vrije Universiteit
  • Cliniques Universitaires St-Luc
  • I. Interna Klinika, Fakultni nemocnice Hradec Kralove
  • Kardiologicke oddeleni, Masarykova nemocnice
  • Amtssygehuset i Gentofte
  • Universitätsklinikum Aachen
  • Zentralkliniken Bad Berka
  • Charite, Campus Benjamin Franklin
  • Vivantes Klinikum Neukölln, Klinik für Innere Medizin
  • Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
  • Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)
  • Universitätsklinikum Freiburg - Innere Medizin III
  • Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I
  • Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III
  • Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie
  • Universität Leipzig, Klinik für Innere Medizin, Herzzentrum
  • Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck
  • Universitätsklinikum Mannheim, I. Medizinische Klinik
  • Deutsches Herzzentrum München
  • Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
  • Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology
  • Onze Lieve Vrouwe Gasthuis
  • St. Antonius Ziekenhuis
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego
  • Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga
  • Institute for Cardiovascular Disease
  • Sahlgrenska Universitetssjukhuset
  • Universitetssjukhuset
  • Universitätshospital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

400 mg injected in 2 divided boluses

Matching placebo

Outcomes

Primary Outcome Measures

Infarct size as measured by cardiac MRI

Secondary Outcome Measures

Myocardial scar mass and left ventricular function

Full Information

First Posted
May 16, 2006
Last Updated
December 3, 2007
Sponsor
Fibrex Medical Research & Development GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00326976
Brief Title
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

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fibrex Medical Research & Development GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Coronary Disease, Myocardial Infarction
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
400 mg injected in 2 divided boluses
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
FX06
Intervention Description
400 mg as intravenous injection in two divided boluses
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Infarct size as measured by cardiac MRI
Time Frame
5-7 days post intervention
Secondary Outcome Measure Information:
Title
Myocardial scar mass and left ventricular function
Time Frame
4 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Atar, MD
Organizational Affiliation
Aker University Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allgemeines Krankenhaus Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Wilhelminen-Spital
City
Vienna
ZIP/Postal Code
A-1171
Country
Austria
Facility Name
Academisch Ziekenhuis van de vrije Universiteit
City
Brussels
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Brussels
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
I. Interna Klinika, Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
CZ-50005
Country
Czech Republic
Facility Name
Kardiologicke oddeleni, Masarykova nemocnice
City
Usti nad Labem
ZIP/Postal Code
40013
Country
Czech Republic
Facility Name
Amtssygehuset i Gentofte
City
Hellerup
ZIP/Postal Code
DK-2900
Country
Denmark
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
D-52057
Country
Germany
Facility Name
Zentralkliniken Bad Berka
City
Bad Berka
ZIP/Postal Code
D-99437
Country
Germany
Facility Name
Charite, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Vivantes Klinikum Neukölln, Klinik für Innere Medizin
City
Berlin
ZIP/Postal Code
D-13436
Country
Germany
Facility Name
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
City
Bernau
ZIP/Postal Code
D-16321
Country
Germany
Facility Name
Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)
City
Düren
ZIP/Postal Code
D-52351
Country
Germany
Facility Name
Universitätsklinikum Freiburg - Innere Medizin III
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I
City
Halle
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III
City
Halle
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Universität Leipzig, Klinik für Innere Medizin, Herzzentrum
City
Leipzig
ZIP/Postal Code
D-04289
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck
City
Lübeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
Universitätsklinikum Mannheim, I. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
D-66167
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
Munich
ZIP/Postal Code
D-80636
Country
Germany
Facility Name
Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
City
Osnabrück
ZIP/Postal Code
D-49074
Country
Germany
Facility Name
Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
NL-1091AC
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
NL-3430 EM
Country
Netherlands
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II
City
Krakow
ZIP/Postal Code
PL-02507
Country
Poland
Facility Name
Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
Facility Name
Institute for Cardiovascular Disease
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Sahlgrenska Universitetssjukhuset
City
Gothenburg
ZIP/Postal Code
S-41345
Country
Sweden
Facility Name
Universitetssjukhuset
City
Linkoeping
ZIP/Postal Code
S-58185
Country
Sweden
Facility Name
Universitätshospital Zürich
City
Zurich
ZIP/Postal Code
CH-8006
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21062778
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.
Results Reference
derived
PubMed Identifier
20542780
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.
Results Reference
derived
PubMed Identifier
19232907
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.
Results Reference
derived

Learn more about this trial

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

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