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

Conditions: coronary sclerosis
10011082

Registration Number: NL-OMON52157

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 520

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

• 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary safety endpoint:<br /><br>Major and CRNM bleeding at 12 months, compared to an objective performance goal<br /><br>(OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies,<br /><br>estimated at 14.1%.<br /><br><br /><br>Primary efficacy endpoint:<br /><br>Composite of all cause mortality, myocardial infarction, stroke and stent<br /><br>thrombosis at 12 months, compared to an OPG of 10.1% for (D)OAC + P2Y12 treated<br /><br>patients.</p><br>

Secondary Outcome Measures

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