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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005972-29 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. YM150 Dose V, twice daily | Experimental |
| |
| 2. YM150 Dose W, once daily | Experimental |
| |
| 3. YM150 Dose X, twice daily | Experimental |
| |
| 4. YM150 Dose Y, once daily | Experimental |
| |
| 5. YM150 Dose Y, twice daily | Experimental |
| |
| 6. YM150 Dose Z, once daily | Experimental |
| |
| 7. Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major and Clinically Relevant Non Major bleeding events | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | C1280AEB | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21878434 | Derived | Steg PG, Mehta SR, Jukema JW, Lip GY, Gibson CM, Kovar F, Kala P, Garcia-Hernandez A, Renfurm RW, Granger CB; RUBY-1 Investigators. RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome. Eur Heart J. 2011 Oct;32(20):2541-54. doi: 10.1093/eurheartj/ehr334. Epub 2011 Aug 30. |
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| Placebo | Drug | oral |
|
| Corrientes |
| W3400AMZ |
| Argentina |
| Salta | A4400AWG | Argentina |
| Salta | A4406CLA | Argentina |
| Concord | 2139 | Australia |
| Douglas | 4814 | Australia |
| Aalst | B9300 | Belgium |
| Bonheiden | B2820 | Belgium |
| Brussels | 1200 | Belgium |
| Brussels | B1000 | Belgium |
| Brussels | B1070 | Belgium |
| Genk | B3600 | Belgium |
| Leper | 8900 | Belgium |
| Ottignies | 1340 | Belgium |
| Brasília | 70658-700 | Brazil |
| Porto Alegre | 90610-000 | Brazil |
| Recife | 52051-380 | Brazil |
| Salvador | 41810-010 | Brazil |
| São José | 88103-901 | Brazil |
| São Paulo | 04012-180 | Brazil |
| Uberlândia | 38400-368 | Brazil |
| Cambridge | N1R 6V6 | Canada |
| Hamilton | L8L 2X2 | Canada |
| Laval | H7M 3L9 | Canada |
| Longueuil | J4M 2A5 | Canada |
| Montreal | G1V 4G5 | Canada |
| Montreal | H3G 1A4 | Canada |
| Montreal | J6V 2H2 | Canada |
| Saint-Jérôme | J7Z 5T3 | Canada |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Cartagena | Colombia |
| Floridablanca | Colombia |
| Beroun | 266 01 | Czechia |
| Brno | 625 00 | Czechia |
| Brno | 636 00 | Czechia |
| Jihlava | 586 33 | Czechia |
| Kladno | 272 59 | Czechia |
| Liberec | 460 63 | Czechia |
| Pardubice | 532 03 | Czechia |
| Prague | 10034 | Czechia |
| Sternberk | 785 01 | Czechia |
| Vsetín | 755 01 | Czechia |
| Zlín | 762 75 | Czechia |
| Copenhagen | 2100 | Denmark |
| Paris | 75877 | France |
| Bad Nauheim | 61231 | Germany |
| Dresden | 101067 | Germany |
| Freiburg im Breisgau | Germany |
| Kassel | 34121 | Germany |
| Neuss | 41464 | Germany |
| Balatonfüred | 8230 | Hungary |
| Budapest | 1096 | Hungary |
| Budapest | 1122 | Hungary |
| Debrecen | 4032 | Hungary |
| Miskolc | 3526 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Szeged | 6720 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Ahmedabad | 380 006 | India |
| Ahmedabad | 380014 | India |
| Ahmedabad | 380015 | India |
| Hyderabaad | 500001 | India |
| Hyderabaad | 500072 | India |
| Mangalore | 575004 | India |
| Nagpur | 440012 | India |
| New Delhi | 110018 | India |
| Tamil Nadu | 600037 | India |
| Tirupati | 517507 | India |
| Burócratas del Estado | 78200 | Mexico |
| Guadalajara | 44290 | Mexico |
| Guadalajara | 44340 | Mexico |
| Mérida | 97129 | Mexico |
| Morelia | CP 58070 | Mexico |
| Zapopan | 45040 | Mexico |
| 's-Hertogenbosch | 5211 NL | Netherlands |
| Amsterdam | 1061 AE | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Helmond | 5707 HA | Netherlands |
| Leeuwarden | 8934 AD | Netherlands |
| Nijmegen | 6532 SZ | Netherlands |
| Oss | 5342 BT | Netherlands |
| Bialystok | 15-276 | Poland |
| Elblag | 82-300 | Poland |
| Gdansk | 80-952 | Poland |
| Inowrocław | 88-100 | Poland |
| Krakow | 31-202 | Poland |
| Przemyśl | 37-700 | Poland |
| Baia Mare | 430110 | Romania |
| Brăila | 810249 | Romania |
| Bucharest | 014461 | Romania |
| Bucharest | 020152 | Romania |
| Craiova | 200642 | Romania |
| Oradea | 410169 | Romania |
| Targoviste | 130083 | Romania |
| Târgu Mureş | 540136 | Romania |
| Chelyabinsk | 454136 | Russia |
| Kemerovo | 650002 | Russia |
| Moscow | 111539 | Russia |
| Moscow | 115093 | Russia |
| Moscow | 119620 | Russia |
| Moscow | 127644 | Russia |
| Saratov | 410054 | Russia |
| Tomsk | 643012 | Russia |
| Tyumen | 625023 | Russia |
| Tyumen | 625026 | Russia |
| Yaroslavl | 150062 | Russia |
| Martin | 036 59 | Slovakia |
| Nitra | 949 01 | Slovakia |
| Rimavská Sobota | 979 01 | Slovakia |
| Ružomberok | 034 26 | Slovakia |
| George | 6529 | South Africa |
| Johannesburg | 2193 | South Africa |
| Kuilsriver | 7580 | South Africa |
| Parow | 7500 | South Africa |
| Pinelands | 7405 | South Africa |
| Tongaat | 4399 | South Africa |
| Umhlanga | 4319 | South Africa |
| Western Cape | 7130 | South Africa |
| Worcester | 6850 | South Africa |
| Busan | 603-714 | South Korea |
| Gwangju | 501-757 | South Korea |
| Gyeonggi-do | 471-020 | South Korea |
| Inchon | 405-760 | South Korea |
| Seoul | 135-720 | South Korea |
| Seoul | 158-710 | South Korea |
| Kharkiv | 61002 | Ukraine |
| Kharkiv | 61178 | Ukraine |
| Kyiv | 03152 | Ukraine |
| Zaporizhzhya | 69000 | Ukraine |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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