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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2006

Last Updated Date

December 3, 2007

Start Date ^ICMJE

August 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Infarct size as measured by cardiac MRI [ Time Frame: 5-7 days post intervention ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00326976 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Ischemia
Coronary Disease
Myocardial Infarction

Intervention ^ICMJE

Drug: FX06
400 mg as intravenous injection in two divided boluses
Procedure: Percutaneous coronary intervention

Study Arm (s)

Experimental: 1
400 mg injected in 2 divided boluses
Interventions:
- Drug: FX06
- Procedure: Percutaneous coronary intervention
Placebo Comparator: 2
Matching placebo
Interventions:
- Drug: FX06
- Procedure: Percutaneous coronary intervention

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

234

Completion Date

November 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Czech Republic, Denmark, Germany, Lithuania, Netherlands, Poland, Romania, Sweden, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00326976

Other Study ID Numbers ^ICMJE

FX06AQ-II-01

Has Data Monitoring Committee

Yes

Responsible Party

Dr: Rainer Henning, Fibrex Medical Research & Development GmbH

Study Sponsor ^ICMJE

Fibrex Medical Research & Development GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dan Atar, MD

Aker University Hospital, Oslo, Norway

Information Provided By

Fibrex Medical Research & Development GmbH

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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