E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
new onset atrial fibrallation and paroxysmal atrial fibrillation |
uusi eteisvärinä ja paroksysmaalinen eteisvärinä |
|
E.1.1.1 | Medical condition in easily understood language |
atrial fibrillation |
eteisvärinä |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 main objective of the trial is to investigate wether postopetavine corticosteroid management prevents new-onset atrial fibrillation or activation of paroxysmal atrial fibrallation immediately after mitral valve surgery. |
Tutkimuksen tarkoitus on selvittää, estääkö postoperatiivisesti annettu kortiskosteroidi välittömästi hiippaläppäleikkauksen jälkeen ilmenevän uuden eteisvärinän tai paroksysmaalinen eteisvärinän aktivoitumisen. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
mitral valve surgery (plasty or prostesis), adult, willing to participate, not in chronic atrial fibrillation preoperatively |
hiippaläppäleikkaus (plastia tai proteesi), aikuinen, vapaaehtoinen, ei ole kroonisessa eteisvärinärytmissä ennen hiippaläppäleikkausta |
|
E.4 | Principal exclusion criteria |
not willing to participate, insulin dependent diabetes, active ulcus, oversensitivity or allergy to hydrocortison, chronic atrial fibrillation, psychosis, prolonged stay in intensive care unit postoperatively |
ei halua osallistua, insuliinihoitoinen diabetes, aktiivinen ulcus, yliherkkyys tai allergia hydrocortisonille, krooninen eteisvärinä, psykoosi, pitkittynyt teho-hoito leikkauksen jälkeen |
|
E.5 End points |
E.5.1 | Primary end point(s) |
patient stays in sinus rhytm for 3 days post mitral valve surgery or patient gets atrial fibrillation during first three postoperative days after mitral valve surgery |
potilas pysyy ensimmäisen 3 postoperatiivista vuorokautta sinusrytmissä tai saa eteisvärinän noiden ensimmäisen kolmen postoperatiivisen vuorokauden aikana postoperatiivisesti |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 postoperative days |
3 postoperatiivista vuorokautta |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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 |
|
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |