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

Catholic University of the Sacred Heart

Status and phase: Unknown; Phase 3

Conditions: Polyvascular Disease; Cardiovascular Disease

Treatments: Drug: clopidogrel plus aspirin; Drug: aspirin; Drug: clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00775762

2008-004626-17

Details and patient eligibility

About

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.

Enrollment: 213 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 3 patient groups

aspirin

Active Comparator group

Treatment:

Drug: aspirin

clopidogrel

Active Comparator group

Treatment:

Drug: clopidogrel

clopidogrel plus aspirin

Active Comparator group

Treatment:

Drug: clopidogrel plus aspirin