To evaluate if an individualized antithrombotic P2Y12-inhibitor monotherapy in comparison to an individualized DAPT treatment is superior regarding bleeding events and non-inferior regarding ischemic events in patient with CCS after PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The primary safety endpoint is the incidence of minor, moderate or severe
bleeding (Bleeding Academic Research Consortium 2, 3 and 5)
• Primary efficacy endpoint is the incidence of a composite of cardiovascular
mortality, myocardial infarction, stent thrombosis and stroke.
Secondary outcome
• Individual components and combinations of the primary and secondary end
points.
• To evaluate the net clinical benefit (a composite of all-cause death, MI,
stroke and major bleeding defined as BARC type 3 or 5 bleeding at 12 months)
• Angina frequency and stability, physical limitations, treatment satisfaction
and quality-of-life measured by SF-12 and SAQ
• Direct and indirect costs defined as: costs of medication, bleeding events
needing medical intervention, re-admission due to bleeding or thrombotic event,
prolonged admission time due to ischemic or bleeding events, costs of
genotyping
Background summary
Novel antithrombotic strategies, such as genotype-guided p2y12-inhibitor
selection and ticagrelor monotherapy, instead of routine dual antithrombotic
therapy, have recently been investigated in major randomized controlled trials.
It is unclear whether these therapies can also be applied in all comer patients
undergoing elective percutaneous coronary (PCI) with stenting.
Study objective
To evaluate if an individualized antithrombotic P2Y12-inhibitor monotherapy in
comparison to an individualized DAPT treatment is superior regarding bleeding
events and non-inferior regarding ischemic events in patient with CCS after
PCI.
Study design
A prospective, monocentre, randomized controlled open label trial
Intervention
All patients will be randomized and will undergo CYP2C19 genotyping using a
pharyngeal swab and/or a blood sample.
After CYP2C19 genotyping, patients will be divided into two groups:
Group 1: P2Y12-inhibitor monotherapy.
Patients without a LOF-allel will receive clopidogrel monotherapy (tablet of
75mg once daily) for 12 months. Patients with a LOF-allel will receive
ticagrelor (tablet of 90mg twice daily) or prasugrel (tablet of 10mg once
daily) for 12 months.
Group 2: Dual antiplatelet therapy (DAPT).
Patients without a LOF-allel will receive clopidogrel monotherapy (tablet of
75mg once daily) for 6 months and acetylsalicylic acid (tablet 80mg one daily)
for 12 months.
Patients with a LOF-allel will receive ticagrelor (90mg twice daily) or
prasugrel (tablet of 10mg once daily) for 6 months and acetylsalicylic acid
(tablet 80mg once daily) for 12 months.
The antithrombotic regimen after 12 months will be at the discretion of the
treating cardiologist.
Patients refusing to participate and with no contra-indications, will be asked
for informed consent to use medical relevant data from electronic patient data
systems from hospitals and/or general practitioners, in order to create a third
group of patients receiving standard of care. These patients will not be
subjected to any intervention performed in the trial, nor will they be
questioned. This data will be observational and will only be used for the
descriptive statistics.
All study participants will receive short-form 12 (SF-12) and the the cardiac
disease specific Seattle Angina Questionnaire (SAQ), online and per postal
service, directly after randomization, 4 weeks after PCI, and 365 days after
PCI.
Study burden and risks
At the time of PCI, genotyping (genotyping will occur through Spartan Rx
CYP2C19 device, only when inconclusive, the blood sample will be used for
genotyping) will be done. Blood withdrawal from 60 consecutive patients out of
each group will occur directly after PCI and at 3 months post PCI for platelet
function research. (See study design and sub study addendum). All blood samples
are drawn from venipuncture.
Koekoekslaan 100
Nieuwegein 3435CM
NL
Koekoekslaan 100
Nieuwegein 3435CM
NL
Listed location countries
Age
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
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 |
|---|---|
| EudraCT | EUCTR2020-001666-11-NL |
| CCMO | NL73724.100.20 |