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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

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ClinicalTrials.gov Identifier: NCT00775762
Recruitment Status : Unknown
Verified October 2008 by Catholic University of the Sacred Heart.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2008
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:
Catholic University of the Sacred Heart

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : November 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 [ Time Frame: 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 [ Time Frame: three months ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775762


Contacts
Contact: Luigi M Biasucci, MD lmbiasucci@virgilio.it

Locations
Italy
Catholic University of the Sacred Heart, Department of Cardiovascular Medicine Not yet recruiting
Rome, Italy, 00135
Contact: Luigi M Biasucci, MD       lmbiasucci@virgilio.it   
Principal Investigator: Luigi M Biasucci, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

Responsible Party: Luigi Marzio Biasucci, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00775762     History of Changes
Other Study ID Numbers: 2008-004626-17
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: October 2008

Keywords provided by Catholic University of the Sacred Heart:
Symptomatic Polyvascular disease
Multiple recurrent cardiovascular events

Additional relevant MeSH terms:
Cardiovascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors