Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Body Mass Index ≥ 27 (PLATO-dose)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01509365 |
Recruitment Status
:
Completed
First Posted
: January 13, 2012
Last Update Posted
: May 7, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease Overweight | Drug: clopidogrel | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
No Intervention: sensible
Patients who show adequate response to loading dose of clopidogrel and receive standard 1x75 mg clopidogrel for at least 7 days.
|
|
Active Comparator: simple dose
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.
|
Drug: clopidogrel
1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
|
Experimental: double dose
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.
|
Drug: clopidogrel
2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
|
- Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation [ Time Frame: 6 months ]
- ADP-induced platelet aggregation assessed by VerifyNow test [ Time Frame: 7 days after selection of patients ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509365
Tunisia | |
cardiology department, hospital Fattouma Bourguiba | |
Monastir, Tunisia, 5000 |
Study Chair: | Faouzi Maatouk, MD | hospital Fattouma Bourguiba | |
Principal Investigator: | Khaldoun Ben Hamda, MD | Hospital Fattouma Bourguiba | |
Principal Investigator: | Sonia Hamdi, MD | Hospital Fattouma Bourguiba | |
Principal Investigator: | Mohsen Hassine | Hospital Fattouma Bourguiba |
Responsible Party: | Les Laboratoires des Médicaments Stériles |
ClinicalTrials.gov Identifier: | NCT01509365 History of Changes |
Other Study ID Numbers: |
03 PID 11 |
First Posted: | January 13, 2012 Key Record Dates |
Last Update Posted: | May 7, 2015 |
Last Verified: | October 2014 |
Keywords provided by Les Laboratoires des Médicaments Stériles:
cardiovascular disease maintenance dose clopidogrel overweight antiplatelet agents |
Additional relevant MeSH terms:
Cardiovascular Diseases Overweight Body Weight Signs and Symptoms Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists |
Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |