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Primary objective:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel | Experimental | 75 mg clopidogrel once daily from Day 1 to Week 12 |
|
| Ticlopidine | Active Comparator | 200 mg ticlopidine once daily from Day 1 to Week 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel (SR25990) | Drug | oral administration (tablets) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...) | Week 12 (on treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding adverse events, Serious adverse events, Overall safety | Week 12, 52 (on treatment) | |
| Vascular events | Week 12, 52 (on study) | |
| Safety events of interest (see above) |
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Inclusion Criteria:
Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):
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 |
|---|---|---|
| Hiroshi Shigematsu, Head Professor/MD/PhD | Second Department of Surgery (Vascular Surgery), Tokyo Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23555538 | Derived | Shigematsu H, Komori K, Tanemoto K, Harada Y, Nakamura M. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients. Ann Vasc Dis. 2012;5(3):364-75. doi: 10.3400/avd.oa.12.00039. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D013988 | Ticlopidine |
| ID | Term |
|---|---|
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| ticlopidine |
| Drug |
oral administration (tablets) |
|
| Week 52 (on treatment) |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |