High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

Study Overview
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Brief Summary
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Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.

Official Title
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Clinical Impact of High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures. The PRECLOP Study (Platelet REsponsiveness to CLOpidogrel Treatment After Peripheral Angioplasty or Stenting)

Conditions
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Influence of PRU Values on Primary Outcome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting. Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure. Exclusion Criteria: Acute limb ischemia Coagulation disorders Known allergy to clopidogrel Failure to comply with the antiplatelet treatment protocol Aortoiliac disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Will include patients with PRU values above the optimal cut-off value determined by ROC analysis | |
| Group B<br>Will include patients with PRU values below the optimal cut-off value determined by ROC analysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major event-free survival | 12 months freedom from all causes of death, stroke, index limb amputation, non pre-scheduled minor amputation, index limb bypass surgery and target vessel recanalization (TVR)stratified according to PRU values distribution | 12 months | 
| Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition | Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition measured with VerifyNow P2Y12 assay point-of-care testing, influencing the 12 months primary outcome of major event-free survival estimated by ROC analysis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative predictive value of PRU testing | Positive and negative predictive value of PRU measurement with regard to the primary outcome of major event-free survival | 12 months | 
| Bleeding rate | 12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, platelet inhibition, antiplatelet therapy, peripheral arterial disease, endovascular treatment, angioplasty, stenting