Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Fibrex Medical

Status and phase

Completed

Phase 2

Conditions

Myocardial Ischemia

Myocardial Infarction

Coronary Disease

Treatments

Drug: FX06

Procedure: Percutaneous coronary intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT00326976

FX06AQ-II-01

Details and patient eligibility

About

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

Enrollment

234 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.