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| Name | Class |
|---|---|
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| Medco Health Solutions, Inc. | INDUSTRY |
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This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Active Comparator |
| |
| Clopidogrel | Active Comparator |
| |
| Lansoprazole | Active Comparator | proton pump inhibitor |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | antiplatelet agent |
| |
| Prasugrel |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antiplatelet effect of clopidogrel | change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses | compare persistant antiplatelet hyper reactivity in patients with stable angina and treated with clopidogrel or prasugrel associated with lansoprazole (or placebo) | 14 days |
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Inclusion Criteria :
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpétrière Hospital | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
antiplatelet agent |
|
| Lansoprazole | Drug | proton pum inhibitor |
|
|
| Placebo | Drug | placebo comparator similar to lansoprazole |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D001562 | Benzimidazoles |