Cardiovascular DiseasePhase 4PLATO-doseNCT01509365
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27
A Phase 4 study testing clopidogrel in people with Cardiovascular Disease and Overweight, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiovascular Disease, Overweight
- What is being tested?
- clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTunisia
- Study dates
- Dec 2011to May 2015
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female,
- Old (e) of more than 20 years
- BMI ≥ 27kg.m-2
- Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage)
- Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days)
Who cannot join
- Patients unwilling.
- Patient participating in another study.
- Patients with cardiogenic shock
- Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
- Patients scheduled for surgery in less than 6 months
- ischemic stroke older than 6 weeks.
Show all 14Show fewer
- History of hemorrhagic stroke (any time)
- Patients on or candidates for AVK
- Patients with a different anti ADP (ticlopidine, prasugrel)
- Patients with an indication against clopidogrel (side effects, bleeding ...)
- Thrombocytopenia < 100000/mm3
- anemia (Ht < 30%)
- Thrombocythaemia (Ht > 52%)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
cardiology department, hospital Fattouma Bourguiba
Monastir, Monastir Governorate, 5000
About this study
Official title: Evaluation the Effect of the Double Maintenance Dose of Clopidogrel Versus Single Dose in Patients With Coronary Artery Disease With a BMI ≥ 27 kg.m-2
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.
Read the detailed description
The goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with BMI ≥ 27 kg.m-2 1 - Biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation.
2 - Clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.
- Conditions
- Cardiovascular Disease, Overweight
- Being tested
- clopidogrel
- Keywords
- cardiovascular disease, maintenance dose, clopidogrel, overweight, antiplatelet agents
- Medical subject headings
- Cardiovascular Diseases, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
clopidogrelDrug
1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
| Study group | Role | What they receive |
|---|---|---|
| sensible | No intervention | Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days. |
| simple dose | Active comparator | Patients who show suboptimal response to loading dose of clopidogrel and receive 1x75 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year. Receives: Drug: clopidogrel |
| double dose | Experimental | Patients who show suboptimal response to loading dose of clopidogrel and receive 1x150 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year. Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation
Measured: 6 months
Secondary outcomes (1)
ADP-induced platelet aggregation assessed by VerifyNow test
Measured: 7 days after selection of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Fattouma Bourguiba
- Responsible party
- Sponsor
- Investigators
- Faouzi Maatouk, MD, Study chair, hospital Fattouma BourguibaKhaldoun Ben Hamda, MD, Principal investigator, Hospital Fattouma BourguibaSonia Hamdi, MD, Principal investigator, Hospital Fattouma BourguibaMohsen Hassine, Principal investigator, Hospital Fattouma Bourguiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509365
- Sponsor's protocol ID
- 03 PID 11
- Acronym
- PLATO-dose
- Status last verified
- Oct 2014
- First submitted
- 9 Jan 2012
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of the Double Maintenance Dose of Clopidogrel Versus Single Dose in Patients With Coronary Artery Disease With a BMI ≥ 27 kg.m-2
- ClinicalTrials.gov ID
- NCT01509365
- Acronym / sponsor ID
- PLATO-dose / 03 PID 11
- Conditions
- Cardiovascular Disease, Overweight
- Keywords
- cardiovascular disease, maintenance dose, clopidogrel, overweight, antiplatelet agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Fattouma Bourguiba
- Study start
- Dec 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jan 2012 (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.
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel in the patient population overweight or obese with a body mass index (BMI) ≥ 27 kg.m-2.
Detailed description
The goal is to evaluate the effect of the double maintenance dose of clopidogrel versus single dose in patients with proven coronary and with BMI ≥ 27 kg.m-2 1 - Biologically: study and compare the respective effects of the double dose and single dose of clopidogrel on platelet aggregation.
2 - Clinically: to study and compare the cardiovascular events and adverse effects depending on the dose of clopidogrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sensible | No intervention | –Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days. |
| simple dose | Active comparator | Drug: clopidogrelPatients who show suboptimal response to loading dose of clopidogrel and receive 1x75 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year. |
| double dose | Experimental | Drug: clopidogrelPatients who show suboptimal response to loading dose of clopidogrel and receive 1x150 mg clopidogrel for 1 month followed by standard 75 mg clopidogrel for 3 months to one year. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female,
- Old (e) of more than 20 years
- BMI ≥ 27kg.m-2
- Patients hospitalized for acute coronary syndrome (Whatever the ST segment and troponin dosage)
- Patients with proven coronary candidates for treatment with Clopidogrel (who received a loading dose of 600mg over 2 hours or treated with 75 mg/day or 150mg / day of clopidogrel for longer than 7 days)
Key exclusion criteria (14 listed)
- Patients unwilling.
- Patient participating in another study.
- Patients with cardiogenic shock
- Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
- Patients scheduled for surgery in less than 6 months
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 |
|---|---|---|
| clopidogrel2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year. | Drug | double dose |
| clopidogrel1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year. | Drug | simple dose |
Primary outcome
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation
Time frame: 6 months
1 secondary outcome
ADP-induced platelet aggregation assessed by VerifyNow test
Time frame: 7 days after selection of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
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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.
Faouzi Maatouk, MD study chair
hospital Fattouma Bourguiba
Khaldoun Ben Hamda, MD principal investigator
Hospital Fattouma Bourguiba
Sonia Hamdi, MD principal investigator
Hospital Fattouma Bourguiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel in people with Cardiovascular Disease and Overweight, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 7 May 2015. 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 Tunisia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation (time frame: 6 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 7 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.