chronic coronary syndrome coronary artery disease stable coronary artery disease
Conditions
Interventions
- Group 1: Clopidogrel 50mg QD for at least 10 days, then clopidogrel 25mg QD
for at least 10 days.
- Group 2: Clopidogrel 75mg
- Group 3: Clopidogrel 150mg QD for at least 10 days, then prasugrel 10
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients, male or female, >=18 years of age - Patients treated for coronary artery disease with clopidogrel 75mg QD (aspirin 100mg QD). - Patients must be treated with clopidogrel 75mg for at least one month - Patients must give consent by means of a signed informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Contra-indication for aspirin - Contra-indication for clopidogrel or prasugrel - Occurrence of an ischemic event after PCI or ACS (stroke, myocardial infarction, or coronary revascularization) - Presence of unstable angina complaints. - Presence of two CYP2C19 Loss-of-function (LOF) alleles (*2 or *3) - Scheduled for cardiac valve surgery - Indication for chronic oral anticoagulants - Expected life span of less than one year - Pregnancy - Suboptimal stent placement as determined by the cardiologist. - Patients at increased risk of bleeding with two of the following characteristics: liver cirrhosis with portal hypertension, enhanced bleeding tendency, active malignancy in the past 12 months, thrombocytopenia, major surgery in the past month, spontaneous intracerebral haemorrhage, traumatic intracerebral haemorrhage in the past 12 months, major bleeding requiring hospitalisation or blood transfusion in the past month, ischaemic CVA in the past 5 months. - Known with established stent thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the level of platelet reactivity, measured as Platelet Reaction Unit (PRU) as measured by the VerifyNow system in the different treatment groups and different treatment regimens. HTPR will be assessed, defined by a PRU >208. PRU values in the low and high BW/BMI group will be compared to the PRU values in the normal BW/BMI group. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine if the CYP2C19 genotype has additional effect on the platelet reactivity in the different treatment groups. - To assess the difference between PRU values in the high BW/BMI group during clopidogrel treatment and prasugrel treatment. - To assess possible confounders for high on-treatment platelet reactivity. - During the conduct of the study all clinical endpoints will be registered according to the definitions reported in the appendix. The following clinical endpoints will be reported: mortality (and cause of mortality), myocardial infarction, stent thrombosis, revascularization, stroke and bleedings. | — |
Countries
Netherlands
Outcome results
None listed