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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI |
|
| 2 | Experimental | 600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI. |
|
| 3 | Experimental | 600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | 300 mg |
| |
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-percutaneous coronary intervention elevation of troponin T. | At 6 and 12 months post-PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events. | From the beginning to the end of the study | |
| Standard hematology and blood chemistry. | At 6 and 12 months post-PCI |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Judith Diaz, Md | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi aventis administrative office | México | Mexico |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
600 mg |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |