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Primary objective:
Secondary objectives:
The study consisted of two periods:
All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel | Experimental | Patients received:
|
|
| Ticlopidine | Active Comparator | Patients received:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel (SR25990) | Drug | Form: tablets Route: oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to first safety events of interest | Safety events of interest were:
| 12 Weeks (duble blind treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to first Major Adverse Cardiac Events (MACE) | MACE included:
| 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) |
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Inclusion Criteria:
Stable Angina / Old Myocardial Infarction patients who met all of the following 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 |
|---|---|---|
| Takaaki Issiki, PhD/FACC | Division of Cardiology, Dpt of Medicine, Teikyo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Tokyo | Japan |
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| ticlopidine |
| Drug |
Form: tablets Route: oral |
|
| Placebo | Drug | Form: tablets Route: oral |
|
| Time from randomization to first bleeding events |
| 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) |
| Time from randomization to first Adverse Events / Adverse Drug Reactions | 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) |
| Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE) | MACCE included:
| 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D013988 | Ticlopidine |
| ID | Term |
|---|---|
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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