Patients with coronary artery disease and an indication for PCI
Conditions
Brief summary
Primary safety endpoint: Major and CRNM bleeding at 12 months, compared to an objective performance goal (OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies, estimated at 14.1%., Primary efficacy endpoint: composite of all-cause mortality, myocardial infarction, stroke and stent thrombosis at 12 months, compared to an OPG of 10.1% for (D)OAC + P2Y12 treated patients.
Detailed description
Safety evaluation in study subgroups: major and CRNM bleeding at 12 months, compared between the 4 study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel)., Efficacy evaluation in study subgroups: composite of all-cause mortality, myocardial infarction, stroke and stent thrombosis at 12 months, compared between the 4 study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel)., EQ5D5L questionnaire: a descriptive survey that produces a 5-digit health state profile that represents a level of reported problems for five dimensions of health, to make comparisons between aforementioned patient groups.
Interventions
DRUGClopidogrel Medreg 75 mg filmom obalené tablety
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Major and CRNM bleeding at 12 months, compared to an objective performance goal (OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies, estimated at 14.1%., Primary efficacy endpoint: composite of all-cause mortality, myocardial infarction, stroke and stent thrombosis at 12 months, compared to an OPG of 10.1% for (D)OAC + P2Y12 treated patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation in study subgroups: major and CRNM bleeding at 12 months, compared between the 4 study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel)., Efficacy evaluation in study subgroups: composite of all-cause mortality, myocardial infarction, stroke and stent thrombosis at 12 months, compared between the 4 study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel)., EQ5D5L questionnaire: a descriptive survey that produces a 5-digit health state profile that represents a level of reported problems for five dimensions of health, to make comparisons between aforementioned patient groups. | — |
Countries
Netherlands
Outcome results
None listed