Genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease.
- Conditions
- Peripheral arterial disease
- Registration Number
- NL-OMON26517
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2276
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
-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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method