Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
Phase 2
Completed
- Conditions
- Myocardial IschemiaCoronary DiseaseMyocardial Infarction
- Interventions
- Procedure: Percutaneous coronary intervention
- Registration Number
- NCT00326976
- Lead Sponsor
- Fibrex Medical Research & Development GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 FX06 400 mg injected in 2 divided boluses 1 Percutaneous coronary intervention 400 mg injected in 2 divided boluses 2 FX06 Matching placebo 2 Percutaneous coronary intervention Matching placebo
- Primary Outcome Measures
Name Time Method Infarct size as measured by cardiac MRI 5-7 days post intervention
- Secondary Outcome Measures
Name Time Method Myocardial scar mass and left ventricular function 4 months post intervention
Trial Locations
- Locations (32)
Allgemeines Krankenhaus Wien
🇦🇹Vienna, Austria
Wilhelminen-Spital
🇦🇹Vienna, Austria
Academisch Ziekenhuis van de vrije Universiteit
🇧🇪Brussels, Belgium
Cliniques Universitaires St-Luc
🇧🇪Brussels, Belgium
I. Interna Klinika, Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Kardiologicke oddeleni, Masarykova nemocnice
🇨🇿Usti nad Labem, Czech Republic
Amtssygehuset i Gentofte
🇩🇰Hellerup, Denmark
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Zentralkliniken Bad Berka
🇩🇪Bad Berka, Germany
Charite, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Scroll for more (22 remaining)Allgemeines Krankenhaus Wien🇦🇹Vienna, Austria