Impact of Clopidogrel on diameter and wall thickness of coronary arteries after heart transplantatio
- Conditions
- Transplant vasculopathy after heart transplantation characterized by Stanford type B2 lesions in coronary angiography and by microvasculopathy proven in biopsy.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-016914-25-DE
- Lead Sponsor
- Deutsches Herzzentrum Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method