To establish the relationship between the presence of CYP2C19 loss-of-function alleles in patients receiving clopidogrel after EVAR and the incidence of atherothrombotic events.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the incidence of Major Adverse Cardiac Events
(MACE) and Major Adverse Limb events (MALE).
Secondary outcome
The secondary endpoints will include (a)symptomatic in-stent or mural thrombus
formation, endograft patency rates, aneurysm-related reinterventions, all major
and clinically relevant minor bleeding complications and renal function.
Background summary
There might be an added risk for atherothrombotic events for poor and
intermediate CYP2C19 metabolizers in patients using clopidogrel as compared to
normal metabolizers in patients undergoing endovascular aneurysm repair (EVAR).
Study objective
To establish the relationship between the presence of CYP2C19 loss-of-function
alleles in patients receiving clopidogrel after EVAR and the incidence of
atherothrombotic events.
Study design
A cross-sectional, retrospective cohort study. 300 patients who were on
clopidogrel after EVAR will be included in this study. After written informed
consent, patients will be invited to collect a saliva sample at home. The
samples will be analyzed in het Radboudumc with TaqMan genotyping assays to
detect CYP2C19 *2 and *3 loss-of-function alleles. Clinical data on the
occurrence of atherothrombotic events will be retrieved from the electronic
patient records.
Study burden and risks
Patients will be invited to collect a saliva sample at home, the burden for the
patients is therefore low and there are no risks involved.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74501.091.20 |
| Other | NL9376 |
| OMON | NL-OMON29281 |