Genotype-guided Strategy for Antithrombotic Treatment in Peripheral Arterial Disease. (GENPAD)
Peripheral Arterial Disease
About this trial
This is an interventional prevention trial for Peripheral Arterial Disease
Eligibility 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 PAD
Exclusion Criteria:
- known CYP2C19 genotype or metabolizer state
- treated with coumarins, Non-vitamin K Oral Anti-Coagulants, unfractionated heparin, low molecular weight heparins or double antiplatelet therapy with acetylsalicylic acid and a P2Y12 inhibitor for other indications
- contraindication for clopidogrel, acetylsalicylic acid and/or rivaroxaban
- pregnant or breastfeeding women
- unable to give informed consent (including not being able to understand the Dutch language)
Sites / Locations
- Gelre Ziekenhuizen
- RijnstateRecruiting
- Ziekenhuis Gelderse ValleiRecruiting
- Máxima Medisch Centrum
- Medisch Spectrum Twente
- UMC Groningen
- Ommelander Ziekenhuis
- Maastricht University Medical Center
- RadboudumcRecruiting
- Canisius Wilhelmina HospitalRecruiting
- BernhovenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention group
Comparison group
The intervention includes testing of patients for carriage of the CYP2C19*2 and *3 allele (loss-of-function (LOF) alleles), followed by a genotype guided antithrombotic treatment with either clopidogrel 75mg (without LOF allele, normal metabolizers), clopidogrel 150mg (one LOF allele, intermediate metabolizers), or rivaroxaban 2.5mg twice daily plus acetylsalicylic acid 100mg (two LOF alleles, poor metabolizers).
The comparison group will not be prescribed clopidogrel 75mg without preceding testing for carriage of the CYP2C19*2 and *3 loss-of-function alleles. CYP2C19 genotyping will be performed at the end of the study.