E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute myocardial infarction (AMI) indicated for Percutaneous Coronary Intervention (PCI). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 ce-CMR at 5 days |
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E.2.2 | Secondary objectives of the trial |
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 month 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 and minor bleeding Ventricular arrhythmia (VF, symptomatic or asymptomatic VT) Duration of hospitalization Death from any cause |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 6 hrs; 5. ST elevation of at least 2 mm in at least 3 leads on 12-lead ECG; 6. Primary PCI indicated per standard of care; 7. First MI; 8. Single index lesion with complete occlusion (TIMI flow 0/I) of one target vessel. |
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E.4 | Principal 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 (< 12/Min) or AF; 7.Known moderate to severe renal dysfunction defined as glomerular filtration rate (GFR) < 50 ml/min/1.73 m2; 8.Previous CABG; 9.History of CHF (NYHA-Grade >/= II); 10.BMI > 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 < 10.0 g/dl
20. History of hemorrhagic diathesis or abnormal platelet or clotting function, e.g., · platelets < 150,000/mm3 · INR and partial thromboplastin time (PTT) > 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Final infarct size measured by ce-CMR at 5 days. The magnitude of this difference will be compared between FX06 and placebo treated patients. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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This study will include 220 patients with the aim of having usable data for analysis of the primary outcome measure from at least 190 patients. The treatment phase of the study is one day with follow-up visits at day 5 and a final visit at month 4 (cf. protocol version 2.0, section 7.1, page 29ff). Possible reasons for a study discontinuation by coordinating investigator/sponsor: cf. protocol version 2.0, section 9.7 (page 66). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |