We hypothesize that poor and intermediate CYP2C19 metabolizers using clopidogrel after endovascular aneurysm repair (EVAR) have an increased risk of adverse clinical events related to arterial thrombosis.
ID
Bron
Verkorte titel
Aandoening
Abdominal Aortic Aneurysm
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome will be the occurrence of adverse clinical events related to arterial thrombosis such as incidence of Major Adverse Cardiovascular Events (MACE) and Major Adverse Limb events (MALE).
Achtergrond van het onderzoek
Rationale: Antiplatelet therapy is recommended in all patients with an aneurysm of the abdominal aorta (AAA) and after endovascular aneurysm repair (EVAR). These patients increasingly receive clopidogrel instead of aspirin. A notable portion of the population carries one or two CYP2C19 loss-of-function allele(s) which results in a limited ability to convert the prodrug clopidogrel into its active metabolites. We hypothesize that poor and intermediate CYP2C19 metabolizers using clopidogrel after endovascular aneurysm repair (EVAR) have an increased risk of adverse clinical events related to arterial thrombosis.
Objective: To establish the relationship between the presence of CYP2C19 loss-of-function alleles and the incidence of atherothrombotic events in patients receiving clopidogrel after EVAR.
Study design and population: GEN-EVAR is a cross-sectional, retrospective cohort study including patients (n=300) using clopidogrel after EVAR.
Intervention: After written informed consent, patients will be invited to perform a buccal swab test at home. The samples will be analyzed with the Spartan Cube, which is a point-of-care device 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.
Main study parameters/endpoints: The primary outcome will be the occurrence of adverse clinical events related to arterial thrombosis such as incidence of Major Adverse Cardiovascular Events (MACE) and Major Adverse Limb events (MALE). The incidence of in-stent thrombosis, mural thrombosis and bleedings are secondary endpoints.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be invited to perform a buccal swab test at home, the burden for the patients is therefore low and there are no risks involved.
Doel van het onderzoek
We hypothesize that poor and intermediate CYP2C19 metabolizers using clopidogrel after endovascular aneurysm repair (EVAR) have an increased risk of adverse clinical events related to arterial thrombosis.
Onderzoeksopzet
12 months
Onderzoeksproduct en/of interventie
Testing for carriage of the CYP2C19*2 and *3 loss-of-function alleles.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patients (age 18 years)
- Obtained written informed consent
- Patients with the ability to perform a buccal swab at home
- Patients who underwent EVAR for an infrarenal AAA between January 2016 and April 2020, 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 antiplatelet therapy since EVAR
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Patients with a known CYP2C19 genotype or metabolizer state
- Patients who are treated with other anticoagulants such as aspirin, ticagrelor, prasugrel, coumarins or Non vitamin K Oral Anti-Coagulants (NOACs)
- Patient treated for a juxtarenal AAA with Fenestrated EVAR, Chimney EVAR or open surgical repair
- Patients that have used clopidogrel only temporary after EVAR
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9376 |
| CCMO | NL74501.091.20 |
| OMON | NL-OMON55153 |