E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To assess the clinical efficacy and safety of the prednisone therapy after PCI as a low-tech low-cost systemic alternative to currently available BMS and DES. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10056489 |
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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 |
is the comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two alternative study groups - DES - BMS and oral prednisone All assuming a similar adjunctive conventional medical treatment. |
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E.2.2 | Secondary objectives of the trial |
- cost-effectiveness analysis. This will be calculated considering all patients. This project will be subsequently presented as an amendment . - comparison of the angiographic results. This will be calculated in a representative sub-sample. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with diagnosed CAD either SVD or MVD with signs or symptoms of myocardial ischemia, scheduled for percutaneous revascularization are all candidates. Either native vessels and SVG can be included with de-novo or restenotic lesions. Lesions causing a diameter stenosis 50 in a main coronary artery LAD, RCA, LCx or their principal branches Dg, OM, PL, PDA . Chronic total occlusions successfully recanalized and completely covered with stents with optimal angiographic result and normal TIMI 3 grade flow at the end of the procedure. Stenting or balloon dilatation of small vessels 2.5 to 2.75mm is allowed. Use of rotational devices does not preclude inclusion in the study if a stent is successfully placed after either, DCA or rotablation. Use of multiple stents or balloon PCI to treat bifurcation lesions provisional, Y, T, kissing or crushing is permitted. Stenting the main branch and provisional stenting for the side branch should be the preferred initial approach. |
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E.4 | Principal exclusion criteria |
Diabetes Age over 80 years old Recent Q wave myocardial infarction less than 2 weeks Severe hypertension, uncontrolled despite medical treatment Gastric ulcer or symptomatic gastritis Active infective disease Neoplasia Suboptimal angiographic result of PCI DS 30 or TIMI flow grade 3 |
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E.5 End points |
E.5.1 | Primary end point(s) |
the primary endpoint of the study will be the occurrence of major clinical events MACE at 12 months. |
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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 | 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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
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.8.3 |
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.8.5 | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
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 |