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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Azienda Ospedaliera di Perugia
Sponsor:
Collaborator:
University Of Perugia
Information provided by (Responsible Party):
Paolo Gresele, Azienda Ospedaliera di Perugia
ClinicalTrials.gov Identifier:
NCT01449617
First received: June 23, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Carotid Artery Disease
Drug: Aspirin plus clopidogrel

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study on Predictive Value for Vascular Events of Residual Platelet Aggregation in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera di Perugia:

Primary Outcome Measures:
  • Change in Platelet reactivity [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    assessed by subsequent follow-up

  • Change in Occurence of myocardial infarction [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
    assessed by subsequent follow-up

  • Change in occurrence of lower limb ischemia [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
    assessed by subsequent follow-up


Secondary Outcome Measures:
  • Change in Incidence of restenosis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    assessed by Eco Color Doppler


Biospecimen Retention:   Samples Without DNA

Whole blood samples, plasma samples, serum samples, urines.


Estimated Enrollment: 272
Study Start Date: August 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aspirin plus clopidogrel
Patients undergoing stenting for critical carotid stenosis, either symptomatic (previous events of cerebral ischemia) or asymptomatic, undergoing CAS.
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449617

Contacts
Contact: Paolo Gresele, Prof. 075 5783989 ext 0039 grespa@unipg.it

Locations
Italy
Azienda Ospedaliera di Perugia Recruiting
Perugia, Italy, 06123
Contact: Massimo Lenti, Dr.    075 5783989    grespa@unipg.it   
Principal Investigator: Paolo Gresele, Prof.         
Sponsors and Collaborators
Azienda Ospedaliera di Perugia
University Of Perugia
Investigators
Principal Investigator: Paolo Gresele, Prof. University of Perugia, Italy
  More Information

No publications provided

Responsible Party: Paolo Gresele, Clinical Investigator, Azienda Ospedaliera di Perugia
ClinicalTrials.gov Identifier: NCT01449617     History of Changes
Other Study ID Numbers: UniPG, CEAS
Study First Received: June 23, 2011
Last Updated: July 16, 2014
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera di Perugia:
Carotid stenosis
Aspirin plus Clopidogrel
Residual platelet reactivity

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on September 16, 2014