E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute myocardial infartion (AMI) for Percutaneous Coronary Intervention (PCI). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
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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. |
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E.2.2 | Secondary objectives of the trial |
Final infarct size 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): cardiovasculara death, myocardial infartion or symptom-driven revascularization plus new symptomatic heart failure (NYHA or Killip Class II or greater) and re-hospitaization for any cardiac cause 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.Patients at risk of ischemia/reperfusion injury after primary PCI for acute STEMI; 3.Men or women with no child bearing potential (e.g., post menopause, surgically sterile); 4.18 – 80 years old; 5.Onset of symptoms to balloon time < 6 hrs; 6.ST elevation of at least 2 mm in at least 3 leads on 12-lead ECG; 7.Primary PCI indicated per standard of care; 8.First MI; 9.Single index lesion with complete occlusion (TIMI flow 0/I) of one target vessel. The presence of 2 or 3 vessel disease is not an exclusion criterion so far as there is no other occlusion and as long as no intervention is considered, neither ad hoc nor as a staged procedure. |
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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.Serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, LM dissection, etc.); 6.Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents; 7.Contra indication to CMR: claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; Frequent extrasystoles (> 12/Min) or AF; 8.Known renal dysfunction defined as serum creatinine > 250 µmol/l; 9.Previous CABG; 10.History of CHF; 11.BMI > 35; 12.Patients who cannot communicate reliably with the investigator; 13.Patients who are unlikely to cooperate with the requirements of the study; 14.Patients who are unwilling and/or unable to give informed consent; 15.Patients at increased risk of death from a pre-existing concurrent illness; 16.Patients participating in another clinical study; 17.Patients who have used any other investigational drugs within 1 month of first dosing; 18.Patients who have participated already in this study; 19.Patients who are employees at the investigational site, relatives or spouse of the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Degree of myocardial salvage calculated as the difference between the perfusion defect before and after PCI, determined by SPECT during rest. The magnitude of 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 be carried out using an adaptive design with one adaptive interim analysis planned for 120 patients (60 patients per treatment group). Thus, it is possible to re-estimate the parameters used for the sample size calculation and then to adjust the sample size for the second part of the study (cf. protocol, section 7.10.4, page 49ff). Possible reasons for a study discontinuation by coordinating investigator/sponsor: cf. protocol, section 9.7 (page 57). |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |