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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744613
First Posted: December 6, 2012
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SIABLIS DIMITRIOS, University of Patras
  Purpose
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.

Condition
Influence of PRU Values on Primary Outcome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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)

Further study details as provided by SIABLIS DIMITRIOS, University of Patras:

Primary Outcome Measures:
  • 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

  • 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 Outcome Measures:
  • 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

  • Bleeding rate [ Time Frame: 12 months ]
    12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values


Enrollment: 100
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744613


Locations
Greece
Patras University Hospital
Rion, Achaia, Greece, 26500
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SIABLIS DIMITRIOS, Dimitrios Siablis, Professor of Radiology, University of Patras
ClinicalTrials.gov Identifier: NCT01744613     History of Changes
Other Study ID Numbers: 822
First Submitted: December 5, 2012
First Posted: December 6, 2012
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by SIABLIS DIMITRIOS, University of Patras:
Clopidogrel
platelet inhibition
antiplatelet therapy
peripheral arterial disease
endovascular treatment
angioplasty
stenting

Additional relevant MeSH terms:
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs