Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

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

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allgemeines Krankenhaus Wien, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FX06

Drug

400 mg as intravenous injection in two divided boluses

Percutaneous coronary intervention

Procedure

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

Time frame: 4 months post intervention

Sponsors and collaborators

Lead sponsor

Fibrex Medical Research & Development GmbH

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2007
First posted: May 17, 2006
Registry last updated: Dec 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed