The effect of clopidogrel and prasugrel with and without acetylsalicylic acid (ASA) on hemostatic system activation at the site of plug formation in vivo in ma
- Conditions
- coronary artery disease and acute coronary syndrome
- Registration Number
- EUCTR2010-019643-19-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik f.Innere Medizin I, Abt.f.Hämatologie u.Hämostaseologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
-age between 19 and 50 years
-normal findings on the medical history
-body mass index (BMI) between 15th and 85th percentile of normal
-non-smoking behaviour
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-history of bleeding
-allergy to or contraindication against ASA
-history of or symptoms suggestive for gastrointestinal disease
-abuse of alcoholic beverages
-use of any medication within two weeks before blood sampling.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -to compare the effects of clopidogrel and prasugrel on in vivo and ex vivo<br>hemostatic system activation <br>-to investigate the additional effect of ASA to clopidogrel or prasugrel with <br>regard to their effects on in vivo and ex vivo hemostatic system activation<br>;Secondary Objective: -;Primary end point(s): –ß-TG in shed blood plasma <br>–TxB2 in shed blood plasma<br>–F1+2 in shed blood plasma<br>–D-Dimer in shed blood plasma<br>–number and cellular origin of TF exposing microparticles (MPs) in shed blood plasma<br>
- Secondary Outcome Measures
Name Time Method