intermittent claudication peripheral arterial disease
Conditions
Interventions
None listed
Sponsors
Haaglanden Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 years of age and older Suggestion of peripheral arterial disease Fontaine II: claudication pain in the limb; ABI 50% stenosis. Antiplatelet therapy: clopidogrel
Exclusion criteria
Exclusion criteria: Unable to give informed consent or have a life expectancy of less than one year due to a non-cardiovascular risk profile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of antiplatelet therapy resistance a. Study parameters: antiplatelet resistance, genetic testing CYP2C19. b. Primary endpoint: ii. MACE, major amputation, target vessel revascularisation in PAD Fontaine II patients. Definitions of study parameters/endpoints All definitions pertinent to PAD are based on the 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Disease, in collaboration with the European Society for Vascular Surgery (ESVS).(8) Adherence to drug treatment: Medication use includes therapy initiated 6 months prior to the index date and up to 30 days after the index date. Treatment adherence can be defined as the number of physiotherapy sessions prescribed for walking therapy, and the estimated number of sessions completed. Drug adherence can be estimated by calculating the number of pills prescribed and the estimated number of pills taken each day. Ankle-brachial Index of 30mmHg or a post-exercise ABI >20% is diagnostic of PAD. Exercise therapy is usually applied using the Strandness protocol at a speed of 3km/h and 10% slope. The test is stopped when the patient is unable to continue walking due to limb pain. This is defined as the maximal walking distance. A post-exercise ankle SBP decrease >30 mmHg or a post-exercise ABI decrease >20% are diagnostic of PAD.(8) Fontaine Classification: Clinical stages of lower extremity artery disease, see Table 1(8) MACE: Major adverse cardiovascular events include hospitalisation with the diagnosis of nonfatal myocardial infarction, cardiovascular death or nonfatal stroke. Toe pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the prevalence of clopidogrel and aspirin resistance in the PAD patient population 1. Progression of disease according to the Fontaine Classification. Progression of disease is defined as: i. Fontaine IIa/b and an intervention (endovascular/operation) ii. Fontaine II to Fontaine III (with/without intervention) iii. Fontaine II/III to Fontaine IV (with/without intervention) 2. Investigate the prevalence of CYP2C19 loss-of-function alleles in The Hague region 3. Investigate the prevalence of antiplatelet therapy resistance with the point-of-care VerifyNow Platelet Function Analyser. 4. Evaluate the percentage increase or decrease in all-cause mortality, revascularisation, stent thrombosis in patients with and without antiplatelet therapy resistance as measured by i. VerifyNow ii. Genetic testing of CYP2C19 loss-of-function alleles | — |
Countries
Netherlands
Outcome results
None listed