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
Information source: Catholic University of the Sacred Heart
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polyvascular Disease; Cardiovascular Disease
Intervention: aspirin (Drug); clopidogrel (Drug); clopidogrel plus aspirin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Catholic University of the Sacred Heart Overall contact:
Luigi M Biasucci, MD, Email: lmbiasucci@virgilio.it
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.
Clinical Details
Study design: Basic Science, Randomized, Open Label, Uncontrolled, Parallel Assignment
Primary outcome: 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
Secondary outcome: 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
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Luigi M Biasucci, MD, Email: lmbiasucci@virgilio.it
Catholic University of the Sacred Heart, Department of Cardiovascular Medicine, Rome 00135, Italy
Additional Information
Starting date: November 2008
Ending date: December 2010
Last updated: October 17, 2008
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