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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55822

Enrollment

315

Registered

2018-02-14

Start date

2018-05-07

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent claudication Peripheral artery disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Number and type of atherothrombotic events: CAD, MI, stroke, limb ischemia, and re-vascularisation, all-cause and cardio-vascular mortality (within 1 year of inclusion into the study).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results