Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

Official Title
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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

Conditions
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Myocardial Ischemia, Coronary Disease, Myocardial Infarction

Intervention / Treatment
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* Drug: FX06
* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>400 mg injected in 2 divided boluses | Drug: FX06<br>* 400 mg as intravenous injection in two divided boluses<br>Procedure: Percutaneous coronary intervention<br> <br> |
| Placebo Comparator: 2<br>Matching placebo | Drug: FX06<br>* 400 mg as intravenous injection in two divided boluses<br>Procedure: Percutaneous coronary intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size as measured by cardiac MRI |  | 5-7 days post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial scar mass and left ventricular function |  | 4 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Revascularization