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Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

This study has been completed.
Information provided by:
Fibrex Medical Research & Development GmbH Identifier:
First received: May 16, 2006
Last updated: December 3, 2007
Last verified: December 2007
The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

Condition Intervention Phase
Myocardial Ischemia Coronary Disease Myocardial Infarction Drug: FX06 Procedure: Percutaneous coronary intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by Fibrex Medical Research & Development GmbH:

Primary Outcome Measures:
  • Infarct size as measured by cardiac MRI [ Time Frame: 5-7 days post intervention ]

Secondary Outcome Measures:
  • Myocardial scar mass and left ventricular function [ Time Frame: 4 months post intervention ]

Enrollment: 234
Study Start Date: August 2006
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1
400 mg injected in 2 divided boluses
Drug: FX06
400 mg as intravenous injection in two divided boluses
Procedure: Percutaneous coronary intervention
Placebo Comparator: 2
Matching placebo
Drug: FX06
400 mg as intravenous injection in two divided boluses
Procedure: Percutaneous coronary intervention


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00326976

  Show 32 Study Locations
Sponsors and Collaborators
Fibrex Medical Research & Development GmbH
Principal Investigator: Dan Atar, MD Aker University Hospital, Oslo, Norway
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr: Rainer Henning, Fibrex Medical Research & Development GmbH Identifier: NCT00326976     History of Changes
Other Study ID Numbers: FX06AQ-II-01
Study First Received: May 16, 2006
Last Updated: December 3, 2007

Keywords provided by Fibrex Medical Research & Development GmbH:
Angioplasty, Transluminal, Percutaneous Coronary
Myocardial Revascularization

Additional relevant MeSH terms:
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Reperfusion Injury
Myocardial Reperfusion Injury
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Postoperative Complications
Cardiomyopathies processed this record on August 18, 2017