Genetic Clopidogrel response testing to finetune the antithrombotic regimen in patients undergoing PCI and treated with antiplatelet drugs

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001093-55-NL

Enrollment

520

Registered

2022-04-26

Start date

2022-10-03

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Patients on oral anticoagulation drugs who undergo a percutaneous coronary intervention (PCI) temporarily and treatment with concomitant antiplatelet therapy

Interventions

Trade Name: clopidogrel Pharmaceutical Form: Tablet Trade Name: ticagrelor Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 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 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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
Main Objective: The aim of this study is to evaluate the feasibility and safety of CYP2C19-genotype-guided p2y12 inhibitor selection in patients who are indicated for (D)OAC and require PCI. Both safety and efficacy outcomes will be captured. ;Secondary Objective: •Safety evaluation in study subgroups •Efficacy evaluation in study subgroups •Improvement in quality of life (prior- and post-PCI), as assessed by the EQ5D5L questionnaire. ;Primary end point(s): Major and CRNM (Clinically Relevant Non Major) bleeding at 12 months, compared to an objective performance goal (OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies;Timepoint(s) of evaluation of this end point: at 12 month	—

Measure

Time frame

Main Objective: The aim of this study is to evaluate the feasibility and safety of CYP2C19-genotype-guided p2y12 inhibitor selection in patients who are indicated for (D)OAC and require PCI. Both safety and efficacy outcomes will be captured. ;Secondary Objective: •Safety evaluation in study subgroups •Efficacy evaluation in study subgroups •Improvement in quality of life (prior- and post-PCI), as assessed by the EQ5D5L questionnaire. ;Primary end point(s): Major and CRNM (Clinically Relevant Non Major) bleeding at 12 months, compared to an objective performance goal (OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies;Timepoint(s) of evaluation of this end point: at 12 month

—

Secondary

Measure	Time frame
Secondary end point(s): none specifiied;Timepoint(s) of evaluation of this end point: n.a.	—

Countries

Netherlands

Contacts

Public ContactJeroen Wilschut

Erasmus Medical Center

j.wilschut@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026