Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04619927
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04619927
Study Brief:
Protocol Section:
NCT04619927