Prescribing antithrombotic therapy in peripheral arterial disease, based on a DNA test.

Phase 1

• Conditions: Symptomatic or stable pheripheral artery disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004913-11-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2244

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 symptoms
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 744
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500

Exclusion Criteria

- known CYP2C19*2 and *3 status
- treated with coumarins, Non-vitamin K Oral Anti-Coagulants, unfractionated heparin, low molecular weight heparins or double antiplatelet therapy for other indications
- contraindication for clopidogrel, acetylsalicylic acid and/or rivaroxaban
- life expectancy of less than 1 year
- pregnant or breastfeeding women
- unable to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified