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| Name | Class |
|---|---|
| University Hospital Fattouma Bourguiba | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | 2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ADP-induced platelet aggregation assessed by VerifyNow test | 7 days after selection of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faouzi Maatouk, MD | hospital Fattouma Bourguiba | Study Chair |
| Khaldoun Ben Hamda, MD | Hospital Fattouma Bourguiba | Principal Investigator |
| Sonia Hamdi, MD | Hospital Fattouma Bourguiba | Principal Investigator |
| Mohsen Hassine | Hospital Fattouma Bourguiba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cardiology department, hospital Fattouma Bourguiba | Monastir | Monastir Governorate | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| clopidogrel | Drug | 1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |