GENPAD
Key facts
- Phase
- Phase 4
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Trial details
- Who runs it
- Radboud universitair medisch centrum Stichting
- Trial code
- NCT04619927EU 2024-518122-33-00
- Record updated
- 13 December 2024
- Original description
to evaluate the ability of genotypeguided antithrombotic treatment to reduce adverse clinical events related to arterial thrombosis in PAD patients. Adverse clinical events of interest are major adverse cardiovascular events (myocardial infarction, stroke, transient ischemic arrack), major adverse limb events (acute/chronic limb ischemia of peripheral vascular intervention including amputation) and death.Read full original descriptionShow less
Genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease (GENPAD)
to evaluate the ability of genotypeguided antithrombotic treatment to reduce adverse clinical events related to arterial thrombosis in PAD patients. Adverse clinical events of interest are major adverse cardiovascular events (myocardial infarction, stroke, transient ischemic arrack), major adverse limb events (acute/chronic limb ischemia of peripheral vascular intervention including amputation) and death.
Inclusion: Age > 16 years; 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: 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; known CYP2C19 genotype or metabolizer state; contraindication for clopidogrel, acetylsalicylic acid and/or rivaroxaban; pregnant or breastfeeding women.