Clinical trial NCT01744613: High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influence of PRU Values on Primary Outcome
Keywords: Clopidogrel
platelet inhibition
antiplatelet therapy
peripheral arterial disease
endovascular treatment
angioplasty
stenting
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Major event-free survival
timeFrame: 12 months
measure: Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition
timeFrame: 12 months
Secondary outcomes:
measure: Positive and negative predictive value of PRU testing
timeFrame: 12 months
measure: Bleeding rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Rion
country: Greece
facility: Patras University Hospital
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Dimitrios Siablis, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital of Patras
name: Dimitrios Karnabatidis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Stavros Spiliopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Georgios Pastromas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Konstantinos Katsanos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spiliopoulos S, Pastromas G, Katsanos K, Kitrou P, Karnabatidis D, Siablis D. Platelet responsiveness to clopidogrel treatment after peripheral endovascular procedures: the PRECLOP study: clinical impact and optimal cutoff value of on-treatment high platelet reactivity. J Am Coll Cardiol. 2013 Jun 18;61(24):2428-2434. doi: 10.1016/j.jacc.2013.03.036. Epub 2013 Apr 16.