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

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00775762
• Other study ID #: 2008-004626-17
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 17, 2008
• Last updated: October 17, 2008
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2008
• Source: Catholic University of the Sacred Heart
• Contact: Luigi M Biasucci, MD
• Email: lmbiasucci[@]virgilio.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 213
• Est. completion date: December 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Polyvascular Disease

Intervention

Drug:
• aspirin
Aspirin (75-100 mg)die for three months
• clopidogrel
Clopidogrel (75mg) die for three months
• clopidogrel plus aspirin
clopidogrel 75 mg die plus aspirin 75-100 mg for three months

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart, Department of Cardiovascular Medicine	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No