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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Polyvascular Disease
• Intervention / Treatment: Drug: aspirin; Drug: clopidogrel; Drug: clopidogrel plus aspirin

• Study Type: Interventional
• Enrollment (Anticipated): 213
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Luigi M Biasucci, MD; Email: lmbiasucci@virgilio.it

Study Locations

• Italy
  • Rome, Italy, 00135
    • Catholic University of the Sacred Heart, Department of Cardiovascular Medicine
    • Contact: Luigi M Biasucci, MD; Email: lmbiasucci@virgilio.it
    • Principal Investigator: Luigi M Biasucci, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): January 1, 2009
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: October 17, 2008
• First Submitted That Met QC Criteria: October 17, 2008
• First Posted (Estimate): October 20, 2008

Study Record Updates

• Last Update Posted (Estimate): October 20, 2008
• Last Update Submitted That Met QC Criteria: October 17, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Symptomatic Polyvascular disease; Multiple recurrent cardiovascular events
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 2008-004626-17