High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures (PRECLOP)

University of Patras

Status: Completed

Conditions: Influence of PRU Values on Primary Outcome

Study type: Observational

Funder types: Other

Identifiers

NCT01744613

822

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Group A

Description:

Will include patients with PRU values above the optimal cut-off value determined by ROC analysis

Group B

Description:

Will include patients with PRU values below the optimal cut-off value determined by ROC analysis.