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

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ClinicalTrials.gov Identifier: NCT01449617
Recruitment Status : Unknown
Verified July 2014 by Paolo Gresele, Azienda Ospedaliera di Perugia.
Recruitment status was:  Recruiting
First Posted : October 10, 2011
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
University Of Perugia
Information provided by (Responsible Party):
Paolo Gresele, Azienda Ospedaliera di Perugia

Tracking Information
First Submitted Date June 23, 2011
First Posted Date October 10, 2011
Last Update Posted Date July 17, 2014
Study Start Date August 2010
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2014)
  • Change in Platelet reactivity [ Time Frame: 1, 6 and 12 months ]
    assessed by VerifyNow (ASA and P2Y12 cartridges), Multiplate (ASA and ADP cartridges), PFA100 (coll/epi; coll/adp; coll/P2Y12 cartridges)
  • Change in Occurrence of stroke [ Time Frame: 1, 6 and 12 months ]
    assessed by subsequent follow-up
  • Change in Occurence of myocardial infarction [ Time Frame: 1, 6 and 12 months ]
    assessed by subsequent follow-up
  • Change in occurrence of lower limb ischemia [ Time Frame: 1, 6 and 12 months ]
    assessed by subsequent follow-up
Original Primary Outcome Measures
 (submitted: October 7, 2011)
  • Change in Platelet reactivity [ Time Frame: 1, 6 and 12 months ]
    assessed by VerifyNow (ASA and P2Y12 cartridges), Multiplate (ASA and ADP cartridges), PFA100 (coll/epi; coll/adp; coll/P2Y12 cartridges)
  • Change in Occurrence of stroke [ Time Frame: 1, 6 and 12 months ]
    assessed by susequent follow-up
  • Change in Occurence of myocardial infarction [ Time Frame: 1, 6 and 12 months ]
    assessed by susequent follow-up
  • Change in occurrence of lower limb ischemia [ Time Frame: 1, 6 and 12 months ]
    assessed by susequent follow-up
Change History Complete list of historical versions of study NCT01449617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 7, 2011)
Change in Incidence of restenosis [ Time Frame: 6 and 12 months ]
assessed by Eco Color Doppler
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Residual Platelet Reactivity in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting
Official Title Observational Study on Predictive Value for Vascular Events of Residual Platelet Aggregation in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting
Brief 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).

Detailed Description

STUDY DESIGN The study will enroll 110 patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.

All patients undergoing CAS in our Center and that fit the predefined Criteria will be enrolled in the study. Dual-antiplatelet treatment with aspirin and clopidogrel will be administered to all patients with the same modalities in use for coronary heart disease patients undergoing PTCA.

Implanted stents after CAS will be in all patients bare metal stents (BMS) and therefore, by analogy with the studies in ACS, the duration of dual-antiplatelet treatment will be of one month; later all patients will be continued indefinitely on aspirin.

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.

Platelet reactivity assessment will be carried-out:

  • before intervention,
  • after 1 week of treatment,
  • after 1 month of treatment
  • after 1 year. All patients will be recalled for clinical examination at 1 and 6 months and at 1 year.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood samples, plasma samples, serum samples, urines.
Sampling Method Probability Sample
Study Population 506 patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
Condition Carotid Artery Disease
Intervention 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.

Other Names:
  • Cardioaspirina
  • Plavix
Study Groups/Cohorts Aspirin plus clopidogrel
Patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
Intervention: Drug: Aspirin plus clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 16, 2014)
272
Original Estimated Enrollment
 (submitted: October 7, 2011)
110
Estimated Study Completion Date March 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  • Informed written consent
  • No contraindications to dual-antiplatelet treatment

Exclusion criteria

  • Age < 18 or > 80 years old
  • Use of oral anticoagulants
  • Use of dipyridamole, cilostazol, NSAIDs
  • Myeloproliferative syndrome or paraproteinemia
  • Liver or kidney failure
  • Thrombocytopathies
  • Platelets count < 100000 or > 450000/µl
  • Haemoglobin < 8g/dl
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01449617
Other Study ID Numbers UniPG
CEAS ( Other Identifier: Comitato Etico delle Aziende Sanitarie dell'Umbria )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Paolo Gresele, Azienda Ospedaliera di Perugia
Study Sponsor Azienda Ospedaliera di Perugia
Collaborators University Of Perugia
Investigators
Principal Investigator: Paolo Gresele, Prof. University of Perugia, Italy
PRS Account Azienda Ospedaliera di Perugia
Verification Date July 2014