High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

Influence of PRU Values on Primary Outcome Clinical Trial

— PRECLOP  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744613
• Other study ID #: 822
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: January 11, 2013
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influence of PRU Values on Primary Outcome

Locations

Country	Name	City	State
Greece	Patras University Hospital	Rion	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	Bleeding rate	12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values	12 months	Yes