Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

U.S. FDA Resources

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

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):

Hallén J, Jensen JK, Fagerland MW, Jaffe AS, Atar D. Cardiac troponin I for the prediction of functional recovery and left ventricular remodelling following primary percutaneous coronary intervention for ST-elevation myocardial infarction. Heart. 2010 Dec;96(23):1892-7.

Hallén J, Petzelbauer P, Schwitter J, Geudelin B, Buser P, Atar D. Impact of time to therapy and presence of collaterals on the efficacy of FX06 in acute ST elevation myocardial infarction: a substudy of the F.I.R.E., the Efficacy of FX06 in the prevention of myocardial reperfusion injury trial. EuroIntervention. 2010 Apr;5(8):946-52.

Atar D, Petzelbauer P, Schwitter J, Huber K, Rensing B, Kasprzak JD, Butter C, Grip L, Hansen PR, Süselbeck T, Clemmensen PM, Marin-Galiano M, Geudelin B, Buser PT; F.I.R.E. Investigators. Effect of intravenous FX06 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction results of the F.I.R.E. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury) trial. J Am Coll Cardiol. 2009 Feb 24;53(8):720-9.

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:

Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Infarction
Ischemia
Myocardial Infarction
Myocardial Reperfusion Injury
Reperfusion Injury
Heart Diseases

Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis
Cardiomyopathies
Postoperative Complications

ClinicalTrials.gov processed this record on May 16, 2013