Skip to main content
OpenTrials
Completed

NCT Number: NCT01744613

High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influence of PRU Values on Primary Outcome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Patras University Hospital

Rio, Achaia, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  1. Positive and negative predictive value of PRU testing

    Time frame: 12 months

    Positive and negative predictive value of PRU measurement with regard to the primary outcome of major event-free survival

  2. Bleeding rate

    Time frame: 12 months

    12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study 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)

Acronym: PRECLOP

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.