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

Catholic University of the Sacred Heart1 site in 1 country213 target enrollmentNovember 2008

ConditionsPolyvascular Disease Cardiovascular Disease

Interventionsaspirin clopidogrel clopidogrel plus aspirin

Drugsaspirin clopidogrel clopidogrel plus aspirin

Overview

Phase: Phase 3
Intervention: aspirin
Conditions: Polyvascular Disease
Sponsor: Catholic University of the Sacred Heart
Enrollment: 213
Locations: 1
Primary Endpoint: 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
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

December 2010

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Catholic University of the Sacred Heart

Eligibility Criteria

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.

Arms & Interventions

aspirin

Intervention: aspirin

clopidogrel

Intervention: clopidogrel

clopidogrel plus aspirin

Intervention: clopidogrel plus aspirin

Outcomes

Primary Outcomes

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

Time Frame: three months

Secondary Outcomes

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)