This study has been transitioned to CTIS with ID 2024-512350-17-01 check the CTIS register for the current data. The aim of this study is to evaluate the feasibility and safety of CYP2C19-genotype-guided p2y12 inhibitor selection in patients who are…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Patients on oral anticoagulation drugs who undergo a percutaneous coronary
intervention (PCI) temporarily need concomitant antiplatelet therapy. The risk
of bleeding in this context is a concern. Genotype-guided p2y12-inhibitor
selection is gaining ground in clinical practice to help guide safe
antiplatelet drug selection. It is unclear whether CYP2C19 genotyping is safe
and could improve antithrombotic strategy selection for patients who are
indicated for treatment with a (non-)vitamin K antagonist ((D)OAC) and require
a percutaneous coronary intervention (PCI).
Study objective
This study has been transitioned to CTIS with ID 2024-512350-17-01 check the CTIS register for the current data.
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. Also a cost-benefit analysis, assessment of quality-of-life and
predictors of bleeding and ischemic outcomes will be studied.
Study design
This study is a prospective, multicenter cohort study
Study burden and risks
At the time of PCI, genotyping will be done either by standard laboratory-based
research or point-of-care testing by oropharyngeal swab. Blood samples (if
necessary) are drawn from venepuncture or from the arterial access sheath which
was used for PCI. There are no major risks or benefits for individual patients
included in this study. The study results of the different patient groups will
provide insight in the antithrombotic strategy selection for patients who are
indicated for treatment with a (non-)vitamin K antagonist ((D)OAC) and require
a percutaneous coronary intervention (PCI).
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-512350-17-01 |
| EudraCT | EUCTR2022-001093-55-NL |
| CCMO | NL77315.078.22 |