ANTIPLATELET TREATMENT FOR PREVENTION OF VASCULAR OUTCOMES IN PAD PATIENTS UNDERGOING PERIPHERAL REVASCULARIZATION.

Conditions: Will be enrolled in the study patients suffering from intermittent claudication in whom resulted ineffective both pharmacological and workout therapy- Will be considered eligible patients aged 40-80 inclusive, with an ankle-brachial index (ABI) <0.9 or > 1.3 at basal condition and diametrical arterial stenosis equal or superior to 50% vessel lumen, undergoing peripheral revascularization procedures.
MedDRA version: 14.1Level: LLTClassification code 10003209Term: ArteriopathySystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-000997-53-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Intermittent claudication affected patients in whom resulted ineffective both pharmacological and workout therapy; Both gender aged 40-80 inclusive; ABI <0.9 or > 1.3; Diametrical arterial stenosis equal or superior to 50% vessel lumen.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 205
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 205

Exclusion Criteria

Critical or acute limb ischemia affected patients; Patients underwent a previous revascularization procedure within 6 months to the enrollment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate antiplatelet treatment resistance percentage, considering the residual platelet activity as superior to 70% using ADP or Arachidonic Acid in vitro aggregation tests.;Secondary Objective: To compare different platelet function test about sensitivity, specificity and future clinical events predictive values; To evaluate the relationship between oxidative stress indexes and platelet activation; To evaluate the antiplatelet treatment resistance role on future clinical events; To evaluate the platelet fuction test predictive role, seric thromboxane levels and oxidative stress indexes levels on future clinical events; To validate a both clinical and laboratory predicitive score to identify the recurrent thrombosis high risk patients; To verify the platelet function tests diffusion in the real world.;Primary end point(s): The target vessels thrombosis absence.;Timepoint(s) of evaluation of this end point: 30 days, 3 months, 6 months, 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The occurrence of a Major Adverse Cardiac Events.;Timepoint(s) of evaluation of this end point: 30 days, 3 months, 6 months, 12 months.