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 study is not yet open for participant recruitment.

Verified by Catholic University of the Sacred Heart, October 2008

First Received: October 17, 2008 No Changes Posted

Sponsored by:	Catholic University of the Sacred Heart
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00775762

Purpose

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	Intervention	Phase
Polyvascular Disease Cardiovascular Disease	Drug: aspirin Drug: clopidogrel Drug: clopidogrel plus aspirin	Phase III

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Uncontrolled, Parallel Assignment

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	213
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
aspirin: Active Comparator	Drug: aspirin Aspirin (75-100 mg)die for three months
clopidogrel: Active Comparator	Drug: clopidogrel Clopidogrel (75mg) die for three months
clopidogrel plus aspirin: Active Comparator	Drug: clopidogrel plus aspirin clopidogrel 75 mg die plus aspirin 75-100 mg for three months

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775762

Contacts

Contact: Luigi M Biasucci, MD

lmbiasucci@virgilio.it

Locations

Italy
Catholic University of the Sacred Heart, Department of Cardiovascular Medicine
Rome, Italy, 00135

Sponsors and Collaborators

Catholic University of the Sacred Heart

More Information

No publications provided

Responsible Party:	Catholic University of the Sacred Heart ( Luigi Marzio Biasucci )
Study ID Numbers:	2008-004626-17
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775762 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Symptomatic Polyvascular disease
Multiple recurrent cardiovascular events

Study placed in the following topic categories:

Anti-Inflammatory Agents
Cyclooxygenase Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Recurrence
Fibrin Modulating Agents
Aspirin

Analgesics, Non-Narcotic
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Platelet Aggregation Inhibitors
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Aspirin

Analgesics, Non-Narcotic
Sensory System Agents
Clopidogrel
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009