Anti-inflammatory and Anti-platelet effect of Clopidogrel and Aspirin vs Aspirin alone in Symptomatic Polyvascular disease and in patients with multiple recurrent cardiovascular events. - ND

Conditions: Polyvascular disease and in patients with multiple recurrent cardiovascular events.
MedDRA version: 9.1Level: LLTClassification code 10032377Term: Other peripheral vascular disease
MedDRA version: 9.1Level: LLTClassification code 10028600Term: Myocardial ischaemia

Registration Number: EUCTR2008-004626-17-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes, between 40 and 75 years of age and with symptomatic polyvascular disease or recurrent cardiovascular events will be included. In particular inclusion criteria include patients with established stable coronary artery disease (no
acute coronary events in the 6 months before study entry with one of the following condition: stable angina with documented multivessels coronary disease, history of multivessel percutaneous coronary intervention, history of multivessel coronary artery bypass grafting or previous MI) associated with peripheral disease (current intermittent claudication and ankle-brachial index0,85 or history of intermittent claudication with previous leg amputation, reconstructive surgery , or angioplasty) or cerebrovascular disease ( a previous documented TIA or Stroke) and patients with more than two acute cardiovascular events ( examples: more than 2 MI,or 2 MI plus one TIA or stroke).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The major exclusion criteria include cronic treatment with oral anticoagulant and other antiplatelet drugs wich might rise the emorragic risk; intollerance/allergy to aspirin or clopidrogrel; platelet count < 125 >145 10 ^/L;
other exclusion criteria are inflammatory or infectious disease, malignancies, or immunologic or hematologic disorders.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Demonstrate a higher occurrence of platelet resistance as measured by TxA2 in polyvasculopatic patients.;Main Objective: the aim of the present study is to demonstrate the superior antinflammatory effect of Clopidogrel and aspirin vs aspirin or clopidogrel alone in term of lower levels of selected circulating inflammatory markers, i.e. CRP, IL-6, TNFalpha, MPO, sCD40L and of nuclear transcription factor kappa-B ( NF-kB) in circulating monocytes and tromboxane B2;Primary end point(s): The primary endpoint will be linked to the justification of the sample size. <br>Primary end-point is the demonstration of a significant reduction in one or more inflammatory markers: CRPIL-6, TNFalpha, MPO, sCD40L and NF-kB ) among the 3 groups of patients with symptomatic polyvascular disease treated with different antiplatelet therapy (group 1: aspirin, group 2: clopidogrel, group 3: aspirin plus clopidogrel).

Secondary Outcome Measures