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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

NCT ID: NCT00775762

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Polyvascular Disease Cardiovascular Disease

Keywords

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Symptomatic Polyvascular disease Multiple recurrent cardiovascular events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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aspirin

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

Aspirin (75-100 mg)die for three months

clopidogrel

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

Clopidogrel (75mg) die for three months

clopidogrel plus aspirin

Group Type ACTIVE_COMPARATOR

clopidogrel plus aspirin

Intervention Type DRUG

clopidogrel 75 mg die plus aspirin 75-100 mg for three months

Interventions

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aspirin

Aspirin (75-100 mg)die for three months

Intervention Type DRUG

clopidogrel

Clopidogrel (75mg) die for three months

Intervention Type DRUG

clopidogrel plus aspirin

clopidogrel 75 mg die plus aspirin 75-100 mg for three months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Catholic University of the Sacred Heart

Locations

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Catholic University of the Sacred Heart, Department of Cardiovascular Medicine

Rome, , Italy

Site Status

Countries

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Italy

Central Contacts

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Luigi M Biasucci, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Luigi M Biasucci, MD

Role: primary

Other Identifiers

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2008-004626-17

Identifier Type: -

Identifier Source: org_study_id