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

NCT01449617 | Unknown

• 2 other identifiers: UniPGCEAS
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

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).

Conditions

Carotid Artery Disease

Keywords

Carotid stenosis; Aspirin plus Clopidogrel; Residual platelet reactivity

Outcome Measures

Primary Outcomes (4)

• Change in Platelet reactivity

  assessed by VerifyNow (ASA and P2Y12 cartridges), Multiplate (ASA and ADP cartridges), PFA100 (coll/epi; coll/adp; coll/P2Y12 cartridges)

  1, 6 and 12 months

• Change in Occurrence of stroke

  assessed by subsequent follow-up

  1, 6 and 12 months

• Change in Occurence of myocardial infarction

  assessed by subsequent follow-up

  1, 6 and 12 months

• Change in occurrence of lower limb ischemia

  assessed by subsequent follow-up

  1, 6 and 12 months

Secondary Outcomes (1)

• Change in Incidence of restenosis

  6 and 12 months

Study Arms (1)

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

Interventions

Aspirin plus clopidogrel DRUG

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.

Also known as: Cardioaspirina, Plavix

Aspirin plus clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia: lead
• University Of Perugia: collaborator

Study Sites (1)

Azienda Ospedaliera di Perugia

Perugia, Italy, 06123, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paolo Gresele, Prof.

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Gresele, Prof.

CONTACT

075 5783989; grespa@unipg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: October 10, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

IT (1)