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The influence of CYP2C19 loss-of-function alleles on atherothrombotic events in patients on clopidogrel after endovascular aneurysm repair (EVAR)

The influence of CYP2C19 loss-of-function alleles on atherothrombotic events in patients on clopidogrel after endovascular aneurysm repair (EVAR) - GEN-EVAR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55153
Enrollment
300
Registered
2021-03-16
Start date
2021-11-22
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYP2C19*2 en *3

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
The primary outcome will be the incidence of Major Adverse Cardiac Events (MACE) and Major Adverse Limb events (MALE).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)