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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2005-004351-35 |
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The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (BAY59-7939) | Drug | 10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes | Treatment period : up to day 36+/-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) | Treatment period : up to day 36+/-6 | |
| Incidence of symptomatic VTE (DVT, PE) | Treatment period : up to day 36+/-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18579811 | Derived | Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374. |
| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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| Enoxaparin |
| Drug |
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days |
|
| Incidence of DVT (total, proximal, distal) | Treatment period : up to day 36+/-6 |
| Incidence of symptomatic VTE during follow-up | Follow-up period: following 36+/-6 days |
| The composite endpoint comprising major VTE and treatment-emergent major bleeding | For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication |
| Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death | Treatment period : up to day 36+/-6 |
| Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death | Treatment period : up to day 36+/-6 |
| Treatment-emergent major bleedings | From first dose of double-blind study medication to up to two days after last dose of double-blind study medication |
| Northport |
| Alabama |
| 35476 |
| United States |
| Phoenix | Arizona | 85023 | United States |
| Benton | Arkansas | 72015 | United States |
| La Jolla | California | 92037 | United States |
| Aurora | Colorado | 80012 | United States |
| Decatur | Georgia | 30033 | United States |
| Missoula | Montana | 59802 | United States |
| Charleston | South Carolina | 29414 | United States |
| Dallas | Texas | 75231 | United States |
| Grapevine | Texas | 76051 | United States |
| Lubbock | Texas | 79410 | United States |
| San Antonio | Texas | 78233 | United States |
| Avellaneda | Buenos Aires | 1870 | Argentina |
| Berazategui | Buenos Aires | 1884 | Argentina |
| Buenos Aires | Buenos Aires F.D. | 1426 | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1039AAO | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1280AEB | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1406FWY | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1425AGP | Argentina |
| Sydney | New South Wales | 2217 | Australia |
| Adelaide | South Australia | 5042 | Australia |
| Melbourne | Victoria | 3128 | Australia |
| Melbourne | Victoria | 3181 | Australia |
| Fremantle | Western Australia | 6160 | Australia |
| Wiener Neustadt | Lower Austria | 2700 | Austria |
| Vienna | State of Vienna | 1140 | Austria |
| Graz | Styria | 8036 | Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Linz | Upper Austria | 4010 | Austria |
| Linz | Upper Austria | 4020 | Austria |
| Ried | Upper Austria | 4910 | Austria |
| Wels | Upper Austria | 4600 | Austria |
| Antwerp | 2020 | Belgium |
| Brasschaat | 2930 | Belgium |
| Bruges | 8000 | Belgium |
| Genk | 3600 | Belgium |
| Hasselt | 3500 | Belgium |
| Huy | 4500 | Belgium |
| Merksem | 2170 | Belgium |
| Pellenberg | 3212 | Belgium |
| Reet | 2840 | Belgium |
| Roeselare | 8800 | Belgium |
| Rio de Janeiro | Rio de Janeiro | 20 232 092 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90470 340 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| São Paulo | São Paulo | 04039-004 | Brazil |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Kitchener | Ontario | N2G 1G3 | Canada |
| Oakville | Ontario | L6J 3L7 | Canada |
| Oshawa | Ontario | L1J 2J2 | Canada |
| Peterborough | Ontario | K9J 7C6 | Canada |
| Stratford | Ontario | N5A 2Y6 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Montreal | Quebec | H3T 1M5 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| Santiago | Chile |
| Bogotá | Colombia |
| České Budějovice | 370 87 | Czechia |
| Hradec Králové | 500 05 | Czechia |
| Jindřichův Hradec | 377 38 | Czechia |
| Karlovy Vary | 360 66 | Czechia |
| Mladá Boleslav | 293 50 | Czechia |
| Olomouc | 775 20 | Czechia |
| Pilsen | 304 60 | Czechia |
| Prague | 169 02 | Czechia |
| Pribram I | 261 26 | Czechia |
| Prostějov | 796 04 | Czechia |
| Frederiksberg | 2000 | Denmark |
| Hellerup | 2900 | Denmark |
| Herlev | 2730 | Denmark |
| Hørsholm | DK-2970 | Denmark |
| Silkeborg | 8600 | Denmark |
| Jyväskylä | 40620 | Finland |
| Mikkeli | FIN-50100 | Finland |
| Seinäjoki | FIN 60220 | Finland |
| Bois-Guillaume | 76230 | France |
| Le Chesnay | 78150 | France |
| Liévin | 62806 | France |
| Monaco | 98000 | France |
| Nantes | 44277 | France |
| Paris | 75019 | France |
| Paris | 75674 | France |
| Paris | 75877 | France |
| Paris | 75960 | France |
| Saint-Herblain | 44819 | France |
| Soyaux | 16800 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Vannes | 56000 | France |
| Bad Mergentheim | Baden-Wurttemberg | 97980 | Germany |
| Heidelberg | Baden-Wurttemberg | 69112 | Germany |
| Rheinfelden | Baden-Wurttemberg | 79618 | Germany |
| Stuttgart | Baden-Wurttemberg | 70176 | Germany |
| Fürth | Bavaria | 90766 | Germany |
| Garmisch-Partenkirchen | Bavaria | 82467 | Germany |
| Würzburg | Bavaria | 97080 | Germany |
| Birkenwerder | Brandenburg | 16547 | Germany |
| Sommerfeld | Brandenburg | 16766 | Germany |
| Bremen | Free Hanseatic City of Bremen | 28205 | Germany |
| Frankfurt am Main | Hesse | 60528 | Germany |
| Frankfurt am Main | Hesse | 65929 | Germany |
| Marburg | Hesse | 35043 | Germany |
| Wiesbaden | Hesse | 65191 | Germany |
| Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Witten | North Rhine-Westphalia | 58448 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Haidari | Attica | 12462 | Greece |
| Kifissia | Attica | 14561 | Greece |
| Kaposvár | Hungary | 7400 | Hungary |
| Békéscsaba | 5600 | Hungary |
| Budapest | 1076 | Hungary |
| Budapest | 1089 | Hungary |
| Győr | 9024 | Hungary |
| Kecskemét | 6000 | Hungary |
| Szeged | 6725 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Beersheba | Israel | 84101 | Israel |
| Haifa | Israel | 31096 | Israel |
| Holon | Israel | 58100 | Israel |
| Kfar Saba | Israel | 44281 | Israel |
| Petah Tikva | Israel | 49100 | Israel |
| Tel Aviv | Israel | 64239 | Israel |
| Ẕerifin | Israel | 70300 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Monza | Milano | 20052 | Italy |
| Rozzano | Milano | 20089 | Italy |
| San Donato Milanese | Milano | 20097 | Italy |
| Gubbio | Perugia | 06024 | Italy |
| Alghero | Sassari | 07041 | Italy |
| Busto Arsizio | Varese | 21052 | Italy |
| Ancona | 60126 | Italy |
| Bergamo | 24128 | Italy |
| Bologna | 40136 | Italy |
| Ferrara | 44100 | Italy |
| Florence | 50139 | Italy |
| Genova | 16132 | Italy |
| Milan | 20132 | Italy |
| Milan | 20162 | Italy |
| Palermo | 90129 | Italy |
| Reggio Emilia | 42100 | Italy |
| Roma | 00168 | Italy |
| Sassari | 07100 | Italy |
| Torino | 10126 | Italy |
| Varese | 21100 | Italy |
| Kaunas | LT-50166 | Lithuania |
| Vilnius | LT-04130 | Lithuania |
| Monterrey | Nuevo León | 64380 | Mexico |
| Monterrey | Nuevo León | 64460 | Mexico |
| Edo. de Mexico | 53120 | Mexico |
| Amsterdam | 1105 AZ | Netherlands |
| Hilversum | 1213 XZ | Netherlands |
| Hoofddorp | 2134 TM | Netherlands |
| Leiden | 2334 CK | Netherlands |
| Nijmegen | 6522 JV | Netherlands |
| Oss | 5342 BT | Netherlands |
| Zwolle | 8011 JW | Netherlands |
| Baerum Postterminal | 1306 | Norway |
| Elverum | 2409 | Norway |
| Gjøvik | 2819 | Norway |
| Lillehammer | 2609 | Norway |
| Notodden | NO-3675 | Norway |
| Bialystok | 15-276 | Poland |
| Bydgoszcz | 85-094 | Poland |
| Bydgoszcz | 85-681 | Poland |
| Gdansk | 80-803 | Poland |
| Katowice | 40-635 | Poland |
| Krakow | 30-901 | Poland |
| Krakow | 31-826 | Poland |
| Krakow | 31-913 | Poland |
| Lodz | 91-002 | Poland |
| Lublin | 20-090 | Poland |
| Lublin | 20-718 | Poland |
| Opole | 45-060 | Poland |
| Poznan | 60-703 | Poland |
| Sosnowiec | 41-200 | Poland |
| Szczecin | 71-252 | Poland |
| Warsaw | 00-909 | Poland |
| Warsaw | 02-005 | Poland |
| Warsaw | 03-242 | Poland |
| Wroclaw | 51-128 | Poland |
| Kosice - Saca | Slovakia | 040 15 | Slovakia |
| Bratislava | 826 06 | Slovakia |
| Žilina | 012 07 | Slovakia |
| Pretoria | Gauteng | 0084 | South Africa |
| Somerset West | Western Cape | 7130 | South Africa |
| Worcester | Western Cape | 6850 | South Africa |
| Santiago de Compostela | A Coruña | 15706 | Spain |
| Badalona | Barcelona | 08916 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08006 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08906 | Spain |
| Castellon | Castellón de La Plana | 12004 | Spain |
| Jaén | Jaén | 23007 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Pamplona | Pamplona | 31008 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Vitoria-Gasteiz | Vitoria | 01009 | Spain |
| Gothenburg | 416 85 | Sweden |
| Halmstad | 301 85 | Sweden |
| Jönköping | 551 85 | Sweden |
| Lidköping | 531 85 | Sweden |
| Varberg | 432 81 | Sweden |
| Västervik | 593 81 | Sweden |
| Adana | 01330 | Turkey (Türkiye) |
| Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul | 34662 | Turkey (Türkiye) |
| Istanbul | 34722 | Turkey (Türkiye) |
| Izmir | 35340 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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