NCT00326976CompletedPhase 2
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
Fibrex Medical Research & Development GmbH32 sites in 11 countries234 target enrollmentStarted: August 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 234
- Locations
- 32
- Primary Endpoint
- Infarct size as measured by cardiac MRI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
1
Experimental
400 mg injected in 2 divided boluses
Intervention: FX06 (Drug)
1
Experimental
400 mg injected in 2 divided boluses
Intervention: Percutaneous coronary intervention (Procedure)
2
Placebo Comparator
Matching placebo
Intervention: FX06 (Drug)
2
Placebo Comparator
Matching placebo
Intervention: Percutaneous coronary intervention (Procedure)
Outcomes
Primary Outcomes
Infarct size as measured by cardiac MRI
Time Frame: 5-7 days post intervention
Secondary Outcomes
- Myocardial scar mass and left ventricular function(4 months post intervention)
Investigators
Study Sites (32)
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