E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Transplant vasculopathy after heart transplantation characterized by Stanford type B2 lesions in coronary angiography and by microvasculopathy proven in biopsy. |
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E.1.1.1 | Medical condition in easily understood language |
Transplantrejection after heart transplantation |
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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 study examines the effect of Clopidogrel in comparison to a placebo, on the increase in maximal coronary intima thickness as shown by intravascular ultrasound in heart-transplanted patients with epicardial transplant vasculopathy |
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E.2.2 | Secondary objectives of the trial |
Reduced progression of epicaridial transplant vasculopathy, determined on the basic of the plaque volume and changes in the luminal area (intravascular ultrasound). Reduced progression of microvascular, determinded by preservation of the coronary flow velocity reserve (intracoronary Doppler flow velocity measurement). Reduced progression of the biopsy-proven microvasculopathy. Decrease in platelet-derived growth factor (PDGF) and vasolidator stimulated phosphorprotein (VASP) content of the peripheral blood and the blood from the coronary sinus as well as the PDGF expression in biopsy. Reduced incidence of fatal myocardial events (acute myocardial infarction, sudden cardiac death graft failure, heart re-transplantation, interventional coronary revascularization (percutaneous transluminal coronary revascularization) coronay artery bypass operation) and improval total survival. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: > 18
Gender: men and women
In women: During the pharmacological treatment a recognized method of contraception must be used.
Written consent to participate in the clinical study, including consent to data protection regulations.
Heart transplantation >= 2,5 years before.
Taking of Everolimus as basic immunosuppression for at least 4 weeks and for a maximum of 6 months in addition. |
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E.4 | Principal exclusion criteria |
Known over-sensitivy to Clopidogrel or another constituent of the preparation.
Age < 18 years
Pregnant or breast feeding women
Heart transplantation < 2 years ago
Acute bleeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduced progression of the epicardial transplant vasculopathy, determined by the maximal intima thickness. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Reduction of fatal myocardiall incidences |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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.8.2.4 | 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 | 6 |
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 | No |
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 | 0 |
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 |