P2y12-receptOr antagonist therapy in patients with coronary artery disease undergoing Percutaneous coronary intervention using an genotype-guided treatment STRATEGY

Phase 4

Withdrawn

Conditions: stable coronary artery disease
10011082
chronic coronary syndrome
coronary artery desisease

Registration Number: NL-OMON52565

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 3526

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 with CCS undergoing successful elective PCI
• Patients with written informed consent as approved by the ethics committee

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 prasugrel, ticagrelor or clopidogrel
• Under the age of 18 years
• Planned cardiac valve surgery
• Need for chronic oral anticoagulation
• PCI when admitted for ACS
• Life expectancy < 1 year
• Unable or unwilling to provide informed consent
• Pregnancy
• Suboptimal result of stenting as defined by the operator
• Any other condition putting patient at excessive risk for bleeding with
ticagrelor
• Treatment with a strong CYP3A4 inhibitor or inducer
• Treatment with a strong CYP2C19 inhibitor or inducer
• History of definite stent thrombosis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• The primary safety endpoint is the incidence of minor, moderate or severe<br /><br>bleeding (Bleeding Academic Research Consortium 2, 3 and 5)<br /><br>• Primary efficacy endpoint is the incidence of a composite of cardiovascular<br /><br>mortality, myocardial infarction, stent thrombosis and stroke.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Individual components and combinations of the primary and secondary end<br /><br>points.<br /><br>• To evaluate the net clinical benefit (a composite of all-cause death, MI,<br /><br>stroke and major bleeding defined as BARC type 3 or 5 bleeding at 12 months)<br /><br>• Angina frequency and stability, physical limitations, treatment satisfaction<br /><br>and quality-of-life measured by SF-12 and SAQ<br /><br>• Direct and indirect costs defined as: costs of medication, bleeding events<br /><br>needing medical intervention, re-admission due to bleeding or thrombotic event,<br /><br>prolonged admission time due to ischemic or bleeding events, costs of<br /><br>genotyping </p><br>