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

• Sponsor: Catholic University of the Sacred Heart (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00775762
• Collaborator: (none)
• Enrollment: 213
• Location: 1
• Arms: 3
• Duration (Months): 25
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polyvascular Disease; Cardiovascular Disease	Drug: aspirin; Drug: clopidogrel; Drug: clopidogrel plus aspirin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 213 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Study Start Date: Nov 1, 2008
• Anticipated Primary Completion Date: Jan 1, 2009
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: aspirin	Drug: aspirin; Aspirin (75-100 mg)die for three months
Active Comparator: clopidogrel	Drug: clopidogrel; Clopidogrel (75mg) die for three months
Active Comparator: clopidogrel plus aspirin	Drug: clopidogrel plus aspirin; clopidogrel 75 mg die plus aspirin 75-100 mg for three months

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of the Sacred Heart, Department of Cardiovascular Medicine	Rome		Italy	00135

Sponsors and Collaborators

• Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00775762
• Other Study ID Numbers: 2008-004626-17
• First Posted: Oct 20, 2008
• Last Update Posted: Oct 20, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: Symptomatic Polyvascular disease; Multiple recurrent cardiovascular events
• Additional relevant MeSH terms: Cardiovascular Diseases; Aspirin; Clopidogrel

Study Results

No Results Posted as of Oct 20, 2008