Angioplasty, Atherosclerosis
Conditions
Keywords
Clopidogrel, Aspirin, Antithrombotic therapy, Platelet function testing
Brief summary
Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.
Interventions
DRUGaspirin
100 mg aspirin
DRUGclopidogrel
75 mg (Arm 1) and 150 mg (Arm 2)
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* written informed consent * angioplasty and stenting for peripheral, coronary or carotid artery disease
Exclusion criteria
* known aspirin or clopidogrel intolerance * therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol) * treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs * family or personal history of bleeding disorders * malignant paraproteinemias * myeloproliferative disorders * heparin-induced thrombocytopenia * severe hepatic failure * known qualitative defects in thrombocyte function * major surgical procedure within one week before enrollment * platelet count \< 100.000 or \> 450.000/µl * hemoglobin \< 8 g/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of major adverse cardiovascular events (MACE) | 3 months |
Countries
Austria
Outcome results
None listed