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

Phase 3

• Conditions: Polyvascular Disease; Cardiovascular Disease
• Interventions: Drug: clopidogrel plus aspirin; Drug: aspirin; Drug: clopidogrel

• Registration Number: NCT00775762
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

This is a monocentric, randomized, opened study to assess the anti-inflammatory and anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular events.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Last Update Submitted: 2008-10-17
• Study First Posted: 2008-10-20
• Last Update Posted: 2008-10-20
• Study Start: 2008-11
• Primary Completion: 2009-01
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• Patients with symptomatic polyvascular disease or recurrent cardiovascular events. In particular patients with established stable coronary artery disease associated with peripheral disease or cerebrovascular disease and patients with more than two acute cardiovascular events.

Exclusion Criteria

• chronic treatment with anticoagulant drugs and the use of other antiplatelet therapy;
• intolerance/allergy to Aspirin or to Clopidogrel
• platelet counts outside the range of 125-450 10^9/l
• inflammatory or infectious disease
• malignancies or immunologic or hematological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clopidogrel plus aspirin	clopidogrel plus aspirin	-
aspirin	aspirin	-
clopidogrel	clopidogrel	-

Primary Outcome Measures

Name	Time	Method
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 levels of selected circulating inflammatory markers	three months

Secondary Outcome Measures

Name	Time	Method
The aim of the present study is to demonstrate the superior antiplatelet effect of Clopidogrel and Aspirin vs Aspirin or Clopidogrel alone in term of TXA2 serum levels	three months

Trial Locations

Locations (1)

Catholic University of the Sacred Heart, Department of Cardiovascular Medicine; 🇮🇹 Rome, Italy