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

NCT00775762 | Unknown Phase 3 DMC

• 1 other identifier: 2008-004626-17
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyvascular Disease; Cardiovascular Disease

Keywords

Symptomatic Polyvascular disease; Multiple recurrent cardiovascular events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

aspirin

ACTIVE COMPARATOR

Drug: aspirin

clopidogrel

ACTIVE COMPARATOR

Drug: clopidogrel

clopidogrel plus aspirin

ACTIVE COMPARATOR

Drug: clopidogrel plus aspirin

Interventions

aspirin DRUG

Aspirin (75-100 mg)die for three months

aspirin

clopidogrel DRUG

Clopidogrel (75mg) die for three months

clopidogrel

clopidogrel plus aspirin DRUG

clopidogrel 75 mg die plus aspirin 75-100 mg for three months

clopidogrel plus aspirin

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart, Department of Cardiovascular Medicine

Rome, 00135, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aspirin; Clopidogrel

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

Central Study Contacts

Luigi M Biasucci, MD

CONTACT

lmbiasucci@virgilio.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2010
• Last Updated: October 20, 2008

Record last verified: 2008-10

Locations

IT (1)