Myocardial IschemiaPhase 2NCT00326976
Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
A Phase 2 study testing FX06 and Percutaneous coronary intervention in people with Myocardial Ischemia and Coronary Disease, run by Fibrex Medical Research & Development GmbH at 32 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Ischemia, Coronary Disease, Myocardial Infarction
- What is being tested?
- FX06 and Percutaneous coronary intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 32 sitesin 11 countries
- Study dates
- Aug 2006to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
32 sites in 11 countries.
32 sites in 11 countries
Germany15 sites
Universitätsklinikum Aachen
Aachen, D-52057
Zentralkliniken Bad Berka
Bad Berka, D-99437
Charite, Campus Benjamin Franklin
Berlin, D-12200
Vivantes Klinikum Neukölln, Klinik für Innere Medizin
Berlin, D-13436
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg
Bernau, D-16321
Krankenhaus Düren gem. GmbH, Innere I (Kardiologie)
Düren, D-52351
Universitätsklinikum Freiburg - Innere Medizin III
Freiburg im Breisgau, D-79106
Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I
Halle, D-06120
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III
Halle, D-06120
Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie
Kiel, D-24105
Universität Leipzig, Klinik für Innere Medizin, Herzzentrum
Leipzig, D-04289
Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck
Lübeck, D-23538
Universitätsklinikum Mannheim, I. Medizinische Klinik
Mannheim, D-66167
Deutsches Herzzentrum München
Munich, D-80636
Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
Osnabrück, D-49074
Poland3 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, PL-02507
Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego
Lodz, 91-347
Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga
Lodz, 91-425
Austria2 sites
Allgemeines Krankenhaus Wien
Vienna, A-1090
Wilhelminen-Spital
Vienna, A-1171
Belgium2 sites
Academisch Ziekenhuis van de vrije Universiteit
Brussels, B-1090
Cliniques Universitaires St-Luc
Brussels, B-1200
Czechia2 sites
I. Interna Klinika, Fakultni nemocnice Hradec Kralove
Hradec Králové, CZ-50005
Kardiologicke oddeleni, Masarykova nemocnice
Ústí nad Labem, 40013
Netherlands2 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, NL-1091AC
St. Antonius Ziekenhuis
Nieuwegein, NL-3430 EM
Sweden2 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, S-41345
Universitetssjukhuset
Linköping, S-58185
Lithuania1 site
Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology
Vilnius, 08661
About this study
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
The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.
- Conditions
- Myocardial Ischemia, Coronary Disease, Myocardial Infarction
- Being tested
- FX06, Percutaneous coronary intervention
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Revascularization
- Medical subject headings
- Myocardial Ischemia, Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX06Drug
400 mg as intravenous injection in two divided boluses
Percutaneous coronary interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 400 mg injected in 2 divided boluses Receives: Drug: FX06; Procedure: Percutaneous coronary intervention |
| 2 | Placebo comparator | Matching placebo Receives: Drug: FX06; Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size as measured by cardiac MRI
Measured: 5-7 days post intervention
Secondary outcomes (1)
Myocardial scar mass and left ventricular function
Measured: 4 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startAug 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fibrex Medical Research & Development GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Atar, MD, Principal investigator, Aker University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326976
- Sponsor's protocol ID
- FX06AQ-II-01
- Status last verified
- Dec 2007
- First submitted
- 16 May 2006
- Last updated
- 4 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21062778Hallen 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.
PubMed 20542780Atar 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.
PubMed 19232907
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00326976
- Acronym / sponsor ID
- FX06AQ-II-01
- Conditions
- Myocardial Ischemia, Coronary Disease, Myocardial Infarction
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Revascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Fibrex Medical Research & Development GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 17 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FX06, Procedure: Percutaneous coronary intervention400 mg injected in 2 divided boluses |
| 2 | Placebo comparator | Drug: FX06, Procedure: Percutaneous coronary interventionMatching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (19 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FX06400 mg as intravenous injection in two divided boluses | Drug | 1, 2 |
| Percutaneous coronary intervention | Procedure or surgery | 1, 2 |
Primary outcome
Infarct size as measured by cardiac MRI
Time frame: 5-7 days post intervention
1 secondary outcome
Myocardial scar mass and left ventricular function
Time frame: 4 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2007.
- Derived from this study: PubMed 21062778Hallen 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.
- Derived from this study: PubMed 20542780Hallen 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.
- Derived from this study: PubMed 19232907Atar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Atar, MD principal investigator
Aker University Hospital, Oslo, Norway
32 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FX06 and Percutaneous coronary intervention in people with Myocardial Ischemia and Coronary Disease, run by Fibrex Medical Research & Development GmbH at 32 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Germany, Poland, Austria, Belgium, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size as measured by cardiac MRI (time frame: 5-7 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326976, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2007; AzTrials last refreshed its copy on 8 Nov 2026.