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Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326976
Recruitment Status : Completed
First Posted : May 17, 2006
Last Update Posted : December 4, 2007
Information provided by:
Fibrex Medical Research & Development GmbH

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
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
Study Start Date : August 2006
Actual Study Completion Date : November 2007

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00326976

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Sponsors and Collaborators
Fibrex Medical Research & Development GmbH
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Principal Investigator: Dan Atar, MD Aker University Hospital, Oslo, Norway
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr: Rainer Henning, Fibrex Medical Research & Development GmbH Identifier: NCT00326976    
Other Study ID Numbers: FX06AQ-II-01
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: December 4, 2007
Last Verified: December 2007
Keywords provided by Fibrex Medical Research & Development GmbH:
Angioplasty, Transluminal, Percutaneous Coronary
Myocardial Revascularization
Additional relevant MeSH terms:
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Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Reperfusion Injury
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications