Genetic Clopidogrel response testing to finetune the antithrombotic regimen in (D)OAC Treated patients undergoing PCI

Genetic Clopidogrel response testing to finetune the antithrombotic regimen in (D)OAC Treated patients undergoing PCI - COATS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52157

Enrollment

520

Registered

2022-04-26

Start date

2023-04-19

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients >= 18 years of age • Patients indicated for indefinite (D)OAC • Patients undergoing successful PCI for stable or unstable (ACS) coronary artery disease • Patients with written informed consent as approved by the ethics committee

Exclusion criteria

Exclusion criteria: • Contraindication to aspirin • Contraindication to ticagrelor or clopidogrel • Under the age of 18 years • Planned cardiac surgery • Life expectancy < 1 year • Unable or unwilling to provide informed consent • Pregnancy • Suboptimal result of stenting as defined by the operator • Need for continued triple antithrombotic therapy per treating physician • Any other condition putting patient at excessive risk for bleeding with ticagrelor • Use of gp2b3a inhibitor • Treatment with a strong CYP3A4 inhibitor or inducer • History of definite stent thrombosis

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
Secondary safety endpoints: Net clinical benefit, ISTH-defined major, CRNM, and minor bleeding and any ISTH-defined bleeding, intracranial and fatal bleeding, and bleeding as per the Bleeding Academic Research Consortium (BARC) and Thrombosis in Myocardial Infarction (TIMI) definitions. Secondary efficacy endpoints: Stroke, ischaemic stroke, haemorrhagic stroke, systemic embolic events, myocardial infarction, definite stent thrombosis, probable stent thrombosis, all-cause death, cardiovascular death, and cardiovascular or unexplained death. Angina frequency and stability, physical limitations, treatment satisfaction and quality-of-life	—

Measure

Time frame

Secondary safety endpoints: Net clinical benefit, ISTH-defined major, CRNM, and minor bleeding and any ISTH-defined bleeding, intracranial and fatal bleeding, and bleeding as per the Bleeding Academic Research Consortium (BARC) and Thrombosis in Myocardial Infarction (TIMI) definitions. Secondary efficacy endpoints: Stroke, ischaemic stroke, haemorrhagic stroke, systemic embolic events, myocardial infarction, definite stent thrombosis, probable stent thrombosis, all-cause death, cardiovascular death, and cardiovascular or unexplained death. Angina frequency and stability, physical limitations, treatment satisfaction and quality-of-life

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Countries

Netherlands

Outcome results