Cardiovascular Disease Clinical Trial
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.
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Italy | Catholic University of the Sacred Heart, Department of Cardiovascular Medicine | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
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 |
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