CEDRIC: Clopidogrel- Effects on Diameter Reduction and Intimal Hyperplasia in Long-term Follow up after Cardiac Transplantation

INTERVENTION: Trade Name: Plavix 75 mg Filmtabletten Clopidogrel Product Name: Plavix Pharmaceutical Form: Capsule, hard CAS Number: 90055‐48‐4 Other descriptive name: CLOPIDOGREL Hydrogensulfat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] Transplant vasculopathy after heart transplantation characterized by Stanford type B2 lesions in coronary angiography and by microvasculopathy proven in biopsy. PRIMARY OUTCOME: Main Objective: 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 Primary end point(s): Reduced progression of the epicardial transplant vasculopathy, determined by the maximal intima thickness. Secondary Objective: 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. Timepoint(s) of evaluation of this end point: after 24 months SECONDARY OUTCOME: Secondary end point(s): Reduction of fatal myocardiall incidences Timepoint(s) of evaluation of this end point: after 24 months 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10