Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

December 3, 2007 updated by: Fibrex Medical Research & Development GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus Wien
      • Vienna, Austria, A-1171
        • Wilhelminen-Spital
  • Belgium
      • Brussels, Belgium, B-1090
        • Academisch Ziekenhuis van de vrije Universiteit
      • Brussels, Belgium, B-1200
        • Cliniques Universitaires St-Luc
  • Czech Republic
      • Hradec Kralove, Czech Republic, CZ-50005
        • I. Interna Klinika, Fakultni nemocnice Hradec Kralove
      • Usti nad Labem, Czech Republic, 40013
        • Kardiologicke oddeleni, Masarykova nemocnice
  • Denmark
      • Hellerup, Denmark, DK-2900
        • Amtssygehuset i Gentofte
  • Germany
      • Aachen, Germany, D-52057
        • Universitätsklinikum Aachen
      • Bad Berka, Germany, D-99437
        • Zentralkliniken Bad Berka
      • Berlin, Germany, D-12200
        • Charite, Campus Benjamin Franklin
      • Berlin, Germany, D-13436
        • Vivantes Klinikum Neukölln, Klinik für Innere Medizin
      • Bernau, Germany, D-16321
        • Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
      • Düren, Germany, D-52351
        • Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)
      • Freiburg, Germany, D-79106
        • Universitätsklinikum Freiburg - Innere Medizin III
      • Halle, Germany, D-06120
        • Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I
      • Halle, Germany, D-06120
        • Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III
      • Kiel, Germany, D-24105
        • Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie
      • Leipzig, Germany, D-04289
        • Universität Leipzig, Klinik für Innere Medizin, Herzzentrum
      • Lübeck, Germany, D-23538
        • Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck
      • Mannheim, Germany, D-66167
        • Universitätsklinikum Mannheim, I. Medizinische Klinik
      • Munich, Germany, D-80636
        • Deutsches Herzzentrum München
      • Osnabrück, Germany, D-49074
        • Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology
  • Netherlands
      • Amsterdam, Netherlands, NL-1091AC
        • Onze Lieve Vrouwe Gasthuis
      • Nieuwegein, Netherlands, NL-3430 EM
        • St. Antonius Ziekenhuis
  • Poland
      • Krakow, Poland, PL-02507
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Lodz, Poland, 91-347
        • Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego
      • Lodz, Poland, 91-425
        • Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga
  • Romania
      • Timisoara, Romania, 300310
        • Institute for Cardiovascular Disease
  • Sweden
      • Gothenburg, Sweden, S-41345
        • Sahlgrenska Universitetssjukhuset
      • Linkoeping, Sweden, S-58185
        • Universitetssjukhuset
  • Switzerland
      • Zurich, Switzerland, CH-8006
        • Universitätshospital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Matching placebo
Procedure: Percutaneous coronary intervention
Drug: FX06
400 mg as intravenous injection in two divided boluses
Experimental: 1
400 mg injected in 2 divided boluses
Procedure: Percutaneous coronary intervention
Drug: FX06
400 mg as intravenous injection in two divided boluses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size as measured by cardiac MRI
Time Frame: 5-7 days post intervention
5-7 days post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial scar mass and left ventricular function
Time Frame: 4 months post intervention
4 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fibrex Medical Research & Development GmbH

Investigators

  • Principal Investigator: Dan Atar, MD, Aker University Hospital, Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

May 16, 2006

First Submitted That Met QC Criteria

May 16, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FX06AQ-II-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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