Target finding for atherothrombosis in a population of patients diagnosed with peripheral obstructive arterial disease.

Completed

• Conditions: Intermittent claudication; Peripheral artery disease; 10014523

• Registration Number: NL-OMON55822
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 315

Inclusion Criteria

- Patients diagnosed with peripheral artery disease, both new patients and
patients currently in follow-up
- Patients currently using Clopidogrel
- Patient provided signed declaration of consent
- Patients are at least 18 years of age and compos mentis.

Exclusion Criteria

- Use of therapeutic doses of anticoagulants (Vitamin K antagonists, DOACs or
Low molecular weight heparins).
- Pregnancy, oral contraceptives, or hormone replacement therapy.
- Chronic inflammatory disease (e.g. RA, CU, MC).
- Anti-phospholipid syndrome (APS).
- Active malignancy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number and type of atherothrombotic events: CAD, MI, stroke, limb ischemia, and<br /><br>re-vascularisation, all-cause and cardio-vascular mortality (within 1 year of<br /><br>inclusion into the study).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The difference between patients that experienced event(s) within 1 year of<br /><br>inclusion into the study and those that did not for 1) coagulation and<br /><br>inflammation profile (levels of D-dimer, Thrombin-Antithrombin, Thrombin<br /><br>generation, FIX-AT complexes, P-selectin, TNF-, Fibrinogen, CRP, V-CAM, I-CAM,<br /><br>CD40, IL1-, IL8, IL10), 2) the difference in platelet reactivity, 3) the<br /><br>difference in adherence rate, and 4) the sensitivity and specificity of a<br /><br>(newly developed) functional assay.<br /><br><br /><br>Other study parameters:<br /><br>Smoking status, age, gender, BMI (height, weight), diabetes, time since<br /><br>diagnosis, extent of disease (mild/moderate, severe PAD), blood pressure,<br /><br>kreatinin and estimated kreatinin clearance, blood glucose, HbA1c, lipid<br /><br>profile (LDL, HDL, cholesterol, triglycerides), concurrent medication.</p><br>