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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

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 20, 2008
Last Update Posted Date October 20, 2008
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Polyvascular Disease
  • Cardiovascular Disease
Intervention  ICMJE
  • Drug: aspirin
    Aspirin (75-100 mg)die for three months
  • Drug: clopidogrel
    Clopidogrel (75mg) die for three months
  • Drug: clopidogrel plus aspirin
    clopidogrel 75 mg die plus aspirin 75-100 mg for three months
Study Arms  ICMJE
  • Active Comparator: aspirin
    Intervention: Drug: aspirin
  • Active Comparator: clopidogrel
    Intervention: Drug: clopidogrel
  • Active Comparator: clopidogrel plus aspirin
    Intervention: Drug: clopidogrel plus aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
213
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775762
Other Study ID Numbers  ICMJE 2008-004626-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luigi Marzio Biasucci, Catholic University of the Sacred Heart
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Catholic University of the Sacred Heart
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP