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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775762

Enrollment

213

Registered

2008-10-20

Start date

2008-11-30

Completion date

2010-12-31

Last updated

2008-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Polyvascular Disease

Keywords

Symptomatic Polyvascular disease, Multiple recurrent cardiovascular events

Brief summary

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.

Interventions

DRUGaspirin

Aspirin (75-100 mg)die for three months

DRUGclopidogrel

Clopidogrel (75mg) die for three months

DRUGclopidogrel plus aspirin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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.

Design outcomes

Primary

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

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

Countries

Italy

Contacts

Primary ContactLuigi M Biasucci, MD

lmbiasucci@virgilio.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026