Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fibrex Medical Research & Development GmbH

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.