Trial | NCT00326976  Report issue

Title

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    triamcinolone ...

  • Study Participants

    234
The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.
Study Started
Aug 31
2006
Study Completion
Nov 30
2007
Last Update
Dec 04
2007
Estimate

Drug FX06

400 mg as intravenous injection in two divided boluses

Procedure Percutaneous coronary intervention

1 Experimental

400 mg injected in 2 divided boluses

2 Placebo Comparator

Matching placebo

Criteria 

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.
No Results Posted