E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients scheduled for cardiac surgery |
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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 | SOC |
E.1.2 | Classification code | 10007541 |
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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 |
To determine whether peri-operative administration of omega-3 reduces occurrence of atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery compared to placebo |
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E.2.2 | Secondary objectives of the trial |
To determine if omega-3 treatment reduces resource utilization as assessed by coronary care unit, telemetry, and total hospital lengths-of-stay. To determine genetic, biologic, autonomic, and electrophysiologic mediators and pathways of effects of omega-3 on cardiac arrhythmia. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:1 Data:2010/08/01 Titolo:Genetica nella Fibrillazione Atriale Obiettivi:Studiare alcuni geni sospettati di avere un ruolo nelle aritmie atriali e valutare se e come tali geni possono essere influenzati dagli omega-3. Ad esempio si valuteranno i geni che codificano o regolano la espressione di canali ionici (ad esempio i canali del Na+ del Ca++), della funzione autonomica (recettori beta) e delle connessine (ad esempio Cx40 e Cx43).
ALTRI SOTTOSTUDI: 1.Biologico 2.Elettrofisiologico
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E.3 | Principal inclusion criteria |
Age 18+ years of age. Scheduled for CS on the following day or later, including coronary artery bypass, valve surgery, any other open cardiac surgery (i.e., that includes opening of the pericardium), or any combination. Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, ectopy and history of AF are acceptable). |
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E.4 | Principal exclusion criteria |
Regular use (3 or more days/week) of fish oil within the past 4 weeks. Known allergy or intolerance to omega-3 or olive oil. Currently pregnant. Unable to provide informed written consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine whether peri-operative administration of omega-3 reduces the occurrence of post- cardiac surgery AF (Fibrillation/Flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG compared to placebo |
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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 | Yes |
E.6.3 | Therapy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 18 |
E.8.5 | The trial involves multiple Member States | No |
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
|
La sperimentazione verra` interrotta se dalla analisi ad interim dovesse emergere un chiaro beneficio/rischio del trattamento sperimentale rispetto al placebo |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |