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Residual Platelet Reactivity in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting

NCT01449617 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2014-07-17

No results posted yet for this study

Summary

A carotid stenosis is treated with invasive procedures of revascularization when the lumen is reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have had symptoms attributable to the affected carotid district in last the 6 months.

Two options for the treatment of patients with carotid stenosis exist currently: the traditional surgical intervention of removal of the plaque by carotid endoarterectomy (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the positioning of a stent through a catheter brought directly in the carotid artery (CAS).

The main complication of both the procedures is early thrombosis, a phenomenon in which platelets play a central role. The importance of an effective inhibition of platelet activation in these patients has been widely demonstrated.

Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment for the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus clopidogrel, as compared with the single drugs. Given that no specific clinical trial has assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from these findings in ischemic heart disease CAS patients are treated with aspirin plus clopidogrel.

Several studies have demonstrated that an elevated residual platelet reactivity despite treatment with clopidogrel is associated to an increased risk of major adverse cardiovascular events (MACE) after stenting for coronary disease.

No data are instead available on the possible predictive value of residual platelet reactivity for the incidence of ischemic cardiovascular events in patients with atherosclerotic carotid disease undergoing CAS with stenting.

Aim of the study will be to assess the predictive value of residual platelet reactivity, as measured by different laboratory tests in patients undergoing CAS with stenting and treated with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major adverse ischemic events).

Conditions

  • Carotid Artery Disease

Interventions

DRUG

Aspirin plus clopidogrel

Clopidogrel, will be started 48 hours before the procedure with a loading dose of of 300mg and continued at 75mg/day. Aspirin will be given at the dose of 100-325mg/day.

Sponsors & Collaborators

  • University Of Perugia

    collaborator OTHER

  • Azienda Ospedaliera di Perugia

    lead OTHER

Principal Investigators

  • Paolo Gresele, Prof. · University Of Perugia

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01449617 on ClinicalTrials.gov