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Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Sponsor
Fibrex Medical Research & Development GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT00326976
Collaborator
(none)
234
Enrollment
32
Locations
2
Arms
15
Duration (Months)
7.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FX06
  • Procedure: Percutaneous coronary intervention
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2006
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

400 mg injected in 2 divided boluses

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

Procedure: Percutaneous coronary intervention
Placebo Comparator: 2

Matching placebo

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

Procedure: Percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

  1. Infarct size as measured by cardiac MRI [5-7 days post intervention]

Secondary Outcome Measures

  1. Myocardial scar mass and left ventricular function [4 months post intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Fibrex Medical Research & Development GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00326976
Other Study ID Numbers:
  • FX06AQ-II-01
First Posted:
May 17, 2006
Last Update Posted:
Dec 4, 2007
Last Verified:
Dec 1, 2007
Keywords provided by , ,
Angioplasty, Transluminal, Percutaneous Coronary
Myocardial Revascularization
Additional relevant MeSH terms:
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Reperfusion Injury
Infarction
Ischemia

Study Results

No Results Posted as of Dec 4, 2007