Polyvascular DiseasePhase 3NCT00775762
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
A Phase 3 study testing aspirin, clopidogrel and clopidogrel plus aspirin in people with Polyvascular Disease and Cardiovascular Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Polyvascular Disease, Cardiovascular Disease
- What is being tested?
- aspirin, clopidogrel and clopidogrel plus aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2008to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Luigi M Biasucci, MD contact
Italy1 site
Catholic University of the Sacred Heart, Department of Cardiovascular Medicine
Rome, 00135
Luigi M Biasucci, MD, lmbiasucci@virgilio.it
Luigi M Biasucci, MD
About this study
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.
- Conditions
- Polyvascular Disease, Cardiovascular Disease
- Being tested
- aspirin, clopidogrel, clopidogrel plus aspirin
- Keywords
- Symptomatic Polyvascular disease, Multiple recurrent cardiovascular events
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
Aspirin (75-100 mg)die for three months
clopidogrelDrug
Clopidogrel (75mg) die for three months
clopidogrel plus aspirinDrug
clopidogrel 75 mg die plus aspirin 75-100 mg for three months
| Study group | Role | What they receive |
|---|---|---|
| aspirin | Active comparator | Not described Receives: Drug: aspirin |
| clopidogrel | Active comparator | Not described Receives: Drug: clopidogrel |
| clopidogrel plus aspirin | Active comparator | Not described Receives: Drug: clopidogrel plus aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three months
Secondary outcomes (1)
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
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyvascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775762
- Sponsor's protocol ID
- 2008-004626-17
- Other IDs
- 2008
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00775762
- Acronym / sponsor ID
- 2008-004626-17
- Conditions
- Polyvascular Disease, Cardiovascular Disease
- Keywords
- Symptomatic Polyvascular disease, Multiple recurrent cardiovascular events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aspirin | Active comparator | Drug: aspirin |
| clopidogrel | Active comparator | Drug: clopidogrel |
| clopidogrel plus aspirin | Active comparator | Drug: clopidogrel plus aspirin |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirinAspirin (75-100 mg)die for three months | Drug | aspirin |
| clopidogrelClopidogrel (75mg) die for three months | Drug | clopidogrel |
| clopidogrel plus aspirinclopidogrel 75 mg die plus aspirin 75-100 mg for three months | Drug | clopidogrel plus aspirin |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi M Biasucci, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aspirin, clopidogrel and clopidogrel plus aspirin in people with Polyvascular Disease and Cardiovascular Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi M Biasucci, MD (lmbiasucci@virgilio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2008.