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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by Catholic University of the Sacred Heart. Recruitment status was Not yet recruiting

First Received on October 17, 2008. No Changes Posted

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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
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

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	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

More Information

No publications provided

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
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
Health Authority:	Italy: Ethics Committee

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012