TICAGRELOR for Coronary artery disease requiring percutaneous coronary intervention

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years of age\n- Patients indicated for indefinite (D)OAC\n- Patients undergoing successful PCI for stable or unstable (ACS) coronary artery disease\n- Patients with written informed consent as approved by the ethics committee"}

Exclusion criteria

• {"criterion_text":"- Contraindication to aspirin\n- History of definite stent thrombosis\n- Contraindication to ticagrelor or clopidogrel\n- Planned cardiac surgery\n- Life expectancy < 1 year\n- Suboptimal result of stenting as defined by the operator\n- Any other condition putting patient at excessive risk for bleeding with ticagrelor\n- Use of gp2b3a inhibitor\n- Need for triple antithrombotic therapy including aspirin per treating physician\n- Treatment with a strong CYP3A4 inhibitor or inducer"}

Primary endpoints

• {"endpoint_text":"- Primary safety endpoint: \tMajor 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%.","definition_or_measurement_approach":"Major and CRNM bleeding events assessed at 12 months and compared against an objective performance goal (OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies (OPG estimated at 14.1%)."}
• {"endpoint_text":"- Primary efficacy endpoint:\tcomposite 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.","definition_or_measurement_approach":"Composite endpoint (all-cause mortality, myocardial infarction, stroke, stent thrombosis) assessed at 12 months and compared to an OPG of 10.1% for (D)OAC + P2Y12 treated patients."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Major and CRNM bleeding at 12 months compared between the four study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Composite efficacy endpoint (all-cause mortality, myocardial infarction, stroke, stent thrombosis) at 12 months compared across the four study groups."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"EQ-5D-5L health-related quality of life questionnaire producing a 5-digit health state profile; descriptive comparisons between patient groups (pre- and post-PCI)."}

Netherlands

Earliest CTIS Part Ii Submission Date

11-09-2024

Latest Decision Or Authorization Date

13-09-2024

Processing Time Days

2

Number Of Sites

2

Number Of Participants

520

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands