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

January 11, 2013 updated by: SIABLIS DIMITRIOS, University of Patras

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Rion, Achaia, Greece, 26500
        • Patras University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patient sampling of all patients undergoing pre-scheduled infrainguinal angioplasty or stenting due to symptomatic arterial disease in our Department from January 2010, treated with clopidogrel 75 mg daily.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A
Will include patients with PRU values above the optimal cut-off value determined by ROC analysis
Group B
Will include patients with PRU values below the optimal cut-off value determined by ROC analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Bleeding rate
Time Frame: 12 months
12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Investigators

  • Study Director: Dimitrios Siablis, MD, PhD, University Hospital of Patras
  • Principal Investigator: Dimitrios Karnabatidis, MD, PhD, University Hospital of Patras
  • Principal Investigator: Stavros Spiliopoulos, MD, PhD, University Hospital of Patras
  • Principal Investigator: Georgios Pastromas, MD, University Hospital of Patras
  • Principal Investigator: Konstantinos Katsanos, MD, PhD, University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (ESTIMATE)

December 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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