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| ID | Type | Description | Link |
|---|---|---|---|
| XRP0673A/2003 | Other Identifier | HMR | |
| 2006-000506-22 | EudraCT Number |
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Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.
Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otamixaban Dose 1 | Experimental | dosage regimen 1 |
|
| Otamixaban Dose 2 | Experimental | dosage regimen 2 |
|
| Otamixaban Dose 3 | Experimental | dosage regimen 3 |
|
| Otamixaban Dose 4 | Experimental | dosage regimen 4 |
|
| Otamixaban Dose 5 | Experimental | dosage regimen 5 |
|
| UFH/Eptifibatide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otamixaban (XRP0673) | Drug | intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor | within 7 days following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding | within 7 days and 30 days following randomization | |
| Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19717184 | Result | Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28. |
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| unfractionated heparin | Drug | intravenous administration |
|
| eptifibatide | Drug | intravenous administration |
|
| within 30 days, 90 days and 180 days following randomization |
| Incidence of TIMI significant bleeding | within 7 days following randomization |
| Incidence of all bleedings | within 7 days and 30 days following randomization |
| Buenos Aires |
| Argentina |
| Sanofi-Aventis Administrative Office | Vienna | Austria |
| Sanofi-Aventis Administrative Office | São Paulo | Brazil |
| Sanofi-Aventis Administrative Office | Sofia | Bulgaria |
| Sanofi-Aventis Administrative Office | Laval | Quebec | Canada |
| Sanofi-Aventis Administrative Office | Santiago | Chile |
| Sanofi-Aventis Administrative Office | Cali | Colombia |
| Sanofi-Aventis Administrative Office | Zagreb | Croatia |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Hørsholm | Denmark |
| Sanofi-Aventis Administrative Office | Tatari | Estonia |
| Sanofi-Aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Athens | Greece |
| Sanofi-Aventis Administrative Office | Budapest | Hungary |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Netanya | Israel |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Kuala Lumpur | Malaysia |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Bucharest | Romania |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Singapore | Singapore |
| Sanofi-Aventis Administrative Office | Bratislava | Slovakia |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |
| Sanofi-Aventis Administrative Office | Taipei | Taiwan |
| Sanofi-Aventis Administrative Office | Bangkok | Thailand |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C435830 | otamixaban |
| D006493 | Heparin |
| D000077542 | Eptifibatide |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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