Patients with acute myocardial infarction (AMI) indicated for Percutaneous Coronary Intervention (PCI). MedDRA version: 8.0 Level: LLT Classification code 10000891
Conditions
Sponsors
Fibrex Medical Research & Development GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given informed consent. 2. Men or women with no child-bearing potential (e.g. post-menopause with amenorrhea > 2 years, surgically sterile. In case of doubt, a pregnancy test must be performed); 3. >18 years old; 4. Onset of symptoms to balloon time =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of MI (from patient history, or from ECG); 2.Chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the AMI; 3.Need for CABG; 4.Administration of any thrombolytic agent since onset of AMI symptoms; 5.Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents; 6.Contra indication to CMR: claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; Frequent extrasystoles ( 35; 11.Patients who cannot communicate reliably with the investigator; 12.Patients who are unlikely to cooperate with the requirements of the study; 13.Patients who are unwilling and/or unable to give informed consent; 14.Patients at increased risk of death from a pre-existing concurrent illness; 15.Patients participating in another clinical study; 16.Patients who have used any other investigational drugs within 1 month of first dosing; 17.Patients who have participated already in this study; 18.Patients who are employees at the investigational site, relatives or spouse of the investigator 19. Patients with a known history of clinically relevant abnormal laboratory values for electrolytes, liver function and hematology, e.g., AST, ALT, alkaline phosphatase, g-GT > 2.5 x ULN - Total bilirubin, amylase: > 1.5 x ULN - Potassium, calcium: outside normal range - Hemoglobin 1.5 x ULN 21. Patients known to suffer from atherosclerotic diseases (especially cerebrovascular), e.g.,TIA or or CVA (thrombo-embolic or hemorrhagic stroke) in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to investigate the cardioprotective efficacy of FX06 as an adjunct to reperfusion therapy in patients with acute myocardial infarction (AMI). In addition, safety and tolerability of FX06 will be assessed. The primary outcome measure of the study is the final infarct size measured by the ce-CMR at 5 days.;Secondary Objective: Degree of myocardial salvage calculated as the difference between the perfusion defect before and after PCI, determined by SPECT during rest (optional) Final infarct size at 4 months measured by CMR; LV function after PCI; Time to ST segment elevation resolution; Troponin I serum concentration; IL-6 serum concentration; Safety and tolerability of FX06; Long-term outcome measures 6 months following AMI: Combined major adverse cardiac event (MACE): cardiovascular death, myocardial infarction or symptom-driven revascularization plus new symptomatic heart failure (NYHA or Killip Class II or greater) and re-hospitalization for any cardiac cause Major or minor bleeding Ventricular arrhythmia (VF, symptomatic or asymptomatic VT) Duration of hospitalization Death from any cause;Primary end point(s): Final infacrt size measured by ce-CMR at 5 days. The magnitude of this difference will be compared between FX06 and placebo treated patients. | — |
Countries
Austria, Czech Republic, Denmark, Germany, Lithuania, Netherlands, Sweden
Outcome results
None listed