Transplant vasculopathy after heart transplantation characterized by Stanford type B2 lesions in coronary angiography and by microvasculopathy proven in biopsy.
Conditions
Interventions
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 uni
Sponsors
Deutsches Herzzentrum Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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. ;Primary end point(s): Reduced progression of the epicardial transplant vasculopathy, determined by the maximal intima thickness. ;Timepoint(s) of evaluation of this end point: after 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reduction of fatal myocardiall incidences ;Timepoint(s) of evaluation of this end point: after 24 months | — |
Countries
Germany
Contacts
Public ContactPD Dr. med. N. Hiemann
Deutsches Herzzentrum Berlin
Outcome results
None listed