Status:
COMPLETED
Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
Lead Sponsor:
Fibrex Medical Research & Development GmbH
Conditions:
Myocardial Ischemia
Coronary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00326976
Start Date
August 1 2006
End Date
November 1 2007
Last Update
December 4 2007
Active Locations (32)
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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