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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000296-15 | EudraCT Number |
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This is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks. |
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| 2 | Active Comparator | Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks. |
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| 3 | Active Comparator | Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks. |
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| 4 | Placebo Comparator | Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E5555 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes | Up to 16 weeks |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Rafal Ziecina, MD | Eisai Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beloit Clinic, SC | Beloit | Wisconsin | 53511-2230 | United States | ||
| Royal Brompton Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21502577 | Derived | O'Donoghue ML, Bhatt DL, Wiviott SD, Goodman SG, Fitzgerald DJ, Angiolillo DJ, Goto S, Montalescot G, Zeymer U, Aylward PE, Guetta V, Dudek D, Ziecina R, Contant CF, Flather MD; LANCELOT-ACS Investigators. Safety and tolerability of atopaxar in the treatment of patients with acute coronary syndromes: the lessons from antagonizing the cellular effects of Thrombin-Acute Coronary Syndromes Trial. Circulation. 2011 May 3;123(17):1843-53. doi: 10.1161/CIRCULATIONAHA.110.000786. Epub 2011 Apr 18. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C540445 | E 5555 |
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|
| London |
| SW3 6NP |
| United Kingdom |