The influence of CYP2C19 loss-of-function alleles on atherothrombotic events in patients on clopidogrel after endovascular aneurysm repair (EVAR)
- Conditions
- CYP2C19*2 en *31000318410002363
- Registration Number
- NL-OMON55153
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
- adult patients (age > 18 years)
- obtained written informed consent
- patients with the ability to perform a buccal swab at home
- patients who were treated for an infrarenal AAA with EVAR between January
2016 and July 2019, including those that were additionally treated with an
iliac branched device and/or coiling of the internal iliac artery
- patients who are on continues treatment with clopidogrel as single
thrombocyte aggregation inhibitor since EVAR
- patients with a known CYP2C19*2 and *3 status
- patients who are treated with other antithrombotic medications (aspirin,
ticagrelor, prasugrel, coumarins, Non-vitamin K Oral Anti-Coagulants (NOACs),
in combination with clopidogrel
- Patient treated for a juxtarenal AAA with Fenestrated-EVAR, Chimney-EVAR or
open surgical repair
- Patients that have used clopidogral only temporary after EVAR
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome will be the incidence of Major Adverse Cardiac Events<br /><br>(MACE) and Major Adverse Limb events (MALE).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints will include (a)symptomatic in-stent or mural thrombus<br /><br>formation, endograft patency rates, aneurysm-related reinterventions, all major<br /><br>and clinically relevant minor bleeding complications and renal function.</p><br>