High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

Completed

• Conditions: Influence of PRU Values on Primary Outcome

• Registration Number: NCT01744613
• Lead Sponsor: University of Patras

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major event-free survival	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Patras University Hospital; 🇬🇷 Rion, Achaia, Greece