Peripheral arterial disease
Conditions
Interventions
Testing for carriage of the CYP2C19*2 and *3 loss-of-function alleles, followed by a genotype guided antithrombotic treatment with either clopidogrel 75mg once daily (normal metabolizers), clopidogrel
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: - Age > 16 years - Obtained written informed consent - Indication for monotherapy clopidogrel 75mg once daily - Ankle-brachial index < 0.9 and/or toe brachial index < 0.5 - Current or previous symptoms due to insufficient vascularization of one or two lower extremities, including intermittent claudication, pain at rest and/or gangrene (Rutherford category 1-6) - Consulting a vascular surgeon for diagnosis, treatment and/or follow-up of peripheral arterial disease
Exclusion criteria
Exclusion criteria: - known CYP2C19 genotype or metabolizer state - treated with coumarins, Non-vitamin K Oral Anti-Coagulants (NOACs), unfractionated heparin (UFH), low molecular weight heparins (LMWH) or double antiplatelet therapy (DAPT) with ASA and a P2Y12 inhibitor for other indications - contraindication for clopidogrel, ASA and/or rivaroxaban - pregnant or breastfeeding women - unable to give informed consent (including not being able to understand the Dutch language)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the number of participants that experienced a major adverse cardiovascular events, major adverse limb events or death from any cause during a median follow-up of 24 months.(range 6 to 36 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: - The number of participants that experienced major adverse cardiovascular events (MACE) during a median follow-up of 24 months.(range 6 to 36 months). MACE is defined as the composite of myocardial infarction, stroke, transient ischemic attack or cardiovascular death - The number of participants that experienced a major adverse limb event (MALE) during a median follow-up of 24 months.(range 6 to 36 months). MALE is defined as the composite of acute limb ischemia, chronic limb ischemia or peripheral vascular intervention. - The number of participants that experienced a major bleeding event during a median follow-up of 24 months.(range 6 to 36 months). Major bleeding includes: 1) fatal bleeding, 2) symptomatic bleeding into a critical organ, 3) bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more or leading to transfusion of two or more units of whole blood or red cells, and 4) bleeding into a surgical site requiring a second intervention. - The number of participants that experienced a clinically relevant bleeding during a median follow-up of 24 months.(range 6 to 36 months). Clinically relevant bleeding includes bleeding that led to: 1) hospitalization (including presentation to an acute care facility without an overnight stay), 2) a physician guided medical or surgical treatment for bleeding, and 3) a change in antithrombotic treatment. | — |
Contacts
Public ContactLoes Willems
Radboudumc
Outcome results
None listed