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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influence of PRU Values on Primary Outcome
- Sponsor
- University of Patras
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Major event-free survival
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
SIABLIS DIMITRIOS
Dimitrios Siablis, Professor of Radiology
University of Patras
Eligibility Criteria
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
Outcomes
Primary Outcomes
Major event-free survival
Time Frame: 12 months
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
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition
Time Frame: 12 months
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
Secondary Outcomes
- Positive and negative predictive value of PRU testing(12 months)
- Bleeding rate(12 months)