High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01744613

Acronym

PRECLOP

Enrollment

100

Registered

2012-12-06

Start date

2010-01-31

Completion date

2013-01-31

Last updated

2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influence of PRU Values on Primary Outcome

Keywords

Clopidogrel, platelet inhibition, antiplatelet therapy, peripheral arterial disease, endovascular treatment, angioplasty, stenting

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Greece

Outcome results