Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

This study has been completed.
Sponsor:
Information provided by:
Fibrex Medical Research & Development GmbH
ClinicalTrials.gov Identifier:
NCT00326976
First received: May 16, 2006
Last updated: December 3, 2007
Last verified: December 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial scar mass and left ventricular function [ Time Frame: 4 months post intervention ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00326976

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

No publications provided by Fibrex Medical Research & Development GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr: Rainer Henning, Fibrex Medical Research & Development GmbH
ClinicalTrials.gov Identifier: NCT00326976     History of Changes
Other Study ID Numbers: FX06AQ-II-01
Study First Received: May 16, 2006
Last Updated: December 3, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Austria: Federal Ministry for Health and Women
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Swedish National Council on Medical Ethics
Switzerland: Swissmedic
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Poland: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: National Medicines Agency

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Reperfusion Injury
Myocardial Reperfusion Injury
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Postoperative Complications
Cardiomyopathies

ClinicalTrials.gov processed this record on October 02, 2014