NCT00326976

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
11 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 4, 2007

Status Verified

December 1, 2007

First QC Date

May 16, 2006

Last Update Submit

December 3, 2007

Conditions

Myocardial IschemiaCoronary DiseaseMyocardial Infarction

Keywords

Angioplasty, Transluminal, Percutaneous CoronaryMyocardial Revascularization

Outcome Measures

Primary Outcomes (1)

  • Infarct size as measured by cardiac MRI

    5-7 days post intervention

Secondary Outcomes (1)

  • Myocardial scar mass and left ventricular function

    4 months post intervention

Study Arms (2)

1

EXPERIMENTAL

400 mg injected in 2 divided boluses

Drug: FX06Procedure: Percutaneous coronary intervention

2

PLACEBO COMPARATOR

Matching placebo

Drug: FX06Procedure: Percutaneous coronary intervention

Interventions

FX06DRUG

400 mg as intravenous injection in two divided boluses

12
Percutaneous coronary interventionPROCEDURE
12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Allgemeines Krankenhaus Wien

Vienna, A-1090, Austria

Location

Wilhelminen-Spital

Vienna, A-1171, Austria

Location

Academisch Ziekenhuis van de vrije Universiteit

Brussels, B-1090, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, B-1200, Belgium

Location

I. Interna Klinika, Fakultni nemocnice Hradec Kralove

Hradec Králové, CZ-50005, Czechia

Location

Kardiologicke oddeleni, Masarykova nemocnice

Ústí nad Labem, 40013, Czechia

Location

Amtssygehuset i Gentofte

Hellerup, DK-2900, Denmark

Location

Universitätsklinikum Aachen

Aachen, D-52057, Germany

Location

Zentralkliniken Bad Berka

Bad Berka, D-99437, Germany

Location

Charite, Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Vivantes Klinikum Neukölln, Klinik für Innere Medizin

Berlin, D-13436, Germany

Location

Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg

Bernau, D-16321, Germany

Location

Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)

Düren, D-52351, Germany

Location

Universitätsklinikum Freiburg - Innere Medizin III

Freiburg im Breisgau, D-79106, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I

Halle, D-06120, Germany

Location

Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III

Halle, D-06120, Germany

Location

Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie

Kiel, D-24105, Germany

Location

Universität Leipzig, Klinik für Innere Medizin, Herzzentrum

Leipzig, D-04289, Germany

Location

Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck

Lübeck, D-23538, Germany

Location

Universitätsklinikum Mannheim, I. Medizinische Klinik

Mannheim, D-66167, Germany

Location

Deutsches Herzzentrum München

Munich, D-80636, Germany

Location

Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover

Osnabrück, D-49074, Germany

Location

Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology

Vilnius, 08661, Lithuania

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, NL-1091AC, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, NL-3430 EM, Netherlands

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, PL-02507, Poland

Location

Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego

Lodz, 91-347, Poland

Location

Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga

Lodz, 91-425, Poland

Location

Institute for Cardiovascular Disease

Timișoara, 300310, Romania

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, S-41345, Sweden

Location

Universitetssjukhuset

Linköping, S-58185, Sweden

Location

Universitätshospital Zürich

Zurich, CH-8006, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 21062778DERIVED

  • 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.

    PMID: 20542780DERIVED

  • 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.

    PMID: 19232907DERIVED

MeSH Terms

Conditions

Myocardial IschemiaCoronary DiseaseMyocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Dan Atar, MD

    Aker University Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 17, 2006

Study Start

August 1, 2006

Study Completion

November 1, 2007

Last Updated

December 4, 2007

Record last verified: 2007-12

Locations

PL(3)BE(2)NL(2)LI(1)SE(2)DE(15)DK(1)RO(1)CH(1)AU(2)CZ(2)