Resistance to Aspirin and Clopidogrel
Conditions
Interventions
Trade Name: PLAVIX
Product Name: PLAVIX
Product Code: ATC-B01
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Clopidogrel
CAS Number: 113665-84-2
Current Sponsor code: Sanofi Synthelabo
Other
Sponsors
Medizinische Universität Wien/ Universitätsklinik für Innere Medizin II/ Angiologie und Kardiologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1100 patients requiring endovascular therapy defined as angioplasty and implantation of bare metal (BMS) or drug eluting stents for cardiovascular or peripheral arterial disease will be included in the study. According to standard clinical practice all patients undergoing angioplasty and bare metal (BMS) or drug eluting stent implantation will be treated with dual antiplatelet therapy for 3 and 12 months, respectively. 100 patients with biochemical resistance to aspirin or clopidogrel in 2 or more tests will be randomized to either 75mg or 150 mg of daily clopidogrel for 3 months after the intervention in addition to aspirin (100mg/day). Written informed consent will be obtained from all patients. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with one of the following conditions will not be included in the study: - known aspirin or clopidogrel incompatibility, - therapy with vitamin k antagonists (warfarin, phenprocoumon), - history of myeloproliferative disorders or heparin-induced thrombocytopenia, - major surgical procedure within one week before enrollment, - a platelet count 450.000/mcl and/or hemoglobin < 8g/dl, - a family or personal history of bleeding disorder, - malignant paraproteinemias, - severe hepatic failure, - lack of written informed consent, - ingestion of ticlopidine, dipyridamole or other nonsteroidal anti-inflammatory drugs, - known qualitative defects in thrombocyte function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In 1100 patients undergoing angioplasty and stenting for cardiovascular disease response to aspirin and clopidogrel will be determined by platelet function analyzer-100 (PFA-100), light transmittance aggregometry (LTA), measurement of the urine excretion rate of the thromboxane A2 (TXA2)-degradation product TXB2, and a point of care bed side test called “VerifyNow” 24 hours after the intervention. All patients undergoing angioplasty and bare metal or drug eluting stent implantation will be treated with dual antiplatelet therapy for 3 and 12 months, respectively. 100 Patients with biochemical resistance to aspirin or clopidogrel in 2 or more tests will be randomized to either 75mg or 150 mg of daily clopidogrel in addition to aspirin (100mg/day) for 3 months after the intervention. In these 100 patients the response to aspirin and clopidogrel will also be determined 3 and 12 months after the intervention. ;Secondary Objective: Genetic analysis of aspirin and clopidogrel resisitance;Primary end point(s): Major adverse cardiovascular event (MACE) rate | — |
Countries
Austria
Outcome results
None listed