E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
adult patients with coronary artery disease and/or valvular disease requiring cardiac surgery with the use of cardiopulmonary bypass. |
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E.1.1.1 | Medical condition in easily understood language |
adult patients with heart disease needing open-heart surgery with the use of heart-lung machine |
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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 primary objective: The primary objective of this study is to evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients. |
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E.2.2 | Secondary objectives of the trial |
Most Important Secondary Objective: 1. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality or significant myocardial injury in high-risk patients Secondary Objectives 2. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients 3. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces postoperative morbidity related to atrial fibrillation, bleeding, delirium, blood transfusions, and length of stay in high-risk patients 4. To evaluate the safety of methylprednisolone. Assessment of the impact on infections, gastrointestinal, and wound complications. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age more or equal to 18 years 2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures) 3. EuroScore greater than or equal to 6 4. Written informed consent |
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E.4 | Principal exclusion criteria |
1. Use of systemic steroids or will undergo planned systemic steroid therapy in the immediate postoperative period (e.g. cardiac transplantation) 2. History of bacterial or fungal infection in the last 30 days 3. Allergy or intolerance to corticosteroids 4. Receiving Aprotinin 5. Previous participation in this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
30-Day post-surgery all-cause mortality |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary end point, all-cause mortality, will be evaluated 30 days after surgery. |
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E.5.2 | Secondary end point(s) |
The incidence of a composite of significant myocardial injury or death at 30 days is the most important secondary end point. All-cause mortality at 6 months, new onset atrial fibrillation, transfusion requirements, bleeding (chest tube output 24 hour), duration of mechanical ventilation, length of ICU stay and hospital stay. Infection, delirium, stroke, wound complication, GI hemorrhage, GI perforation, postoperative insulin use and peak blood glucose during the first 24 hours after surgery. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The most important secondary end point will be evaluated 30 days after surgery. Other efficacy and safety end points will be evaluated at all visits after surgery (at the ICU visit (i.e. 24 hours post-operatively), at the discharge visit, at the 30-day and 6-month follow up visits). |
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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 | No |
E.6.5 | Efficacy | No |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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 |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Chile |
China |
Colombia |
Czech Republic |
Greece |
Hungary |
India |
Iran, Islamic Republic of |
Ireland |
Italy |
South Africa |
Spain |
United States |
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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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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 | 4 |
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 |