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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2005-004620-40 |
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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 prevents blood clot which may form after a knee 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 rivaroxaban (tablet) once daily administered for 13 +/- 2 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 13+/-4 |
| 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 13+/-4 | |
| Incidence of symptomatic VTE (DVT, PE) | Treatment period: up to Day 13+/-4 |
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Inclusion Criteria:- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement Exclusion Criteria:- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1140 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18579812 | Derived | Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Enoxaparin | Drug | Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days |
|
| Incidence of DVT (total, proximal, distal) | Treatment period: up to Day 13+/-4 |
| Incidence of symptomatic VTE during follow-up | Follow-up period: following 13+/-4 days |
| The composite endpoint comprising major VTE and treatment-emergent major bleeding | For major VTE, treatment period: up to Day 13+/-4 ; 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 13+/-4 |
| Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death | Treatment period: up to Day 13+/-4 |
| 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 |
| Graz |
| Styria |
| 8036 |
| Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Linz | Upper Austria | 4010 | Austria |
| Antwerp | 2020 | Belgium |
| Hasselt | 3500 | Belgium |
| Liège | 4000 | Belgium |
| Merksem | 2170 | Belgium |
| Pellenberg | 3212 | Belgium |
| Reet | 2840 | Belgium |
| Roeselare | 8800 | Belgium |
| Penticton | British Columbia | V2A 5C8 | Canada |
| Saint John | New Brunswick | E2L 4L2 | Canada |
| Burlington | Ontario | L7R 4C4 | Canada |
| Kitchener | Ontario | N2G 1G3 | Canada |
| Oakville | Ontario | L6J 3M5 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Peterborough | Ontario | K9J 7C6 | Canada |
| Scarborough Village | Ontario | M1E 4B9 | Canada |
| Windsor | Ontario | N9A 1E1 | Canada |
| Beijing | 100035 | China |
| Beijing | 100044 | China |
| Beijing | 100853 | China |
| Shanghai | 200025 | China |
| Shanghai | 200032 | China |
| Shanghai | 200233 | China |
| Bogotá | Colombia |
| Cali | Colombia |
| Medellín | Colombia |
| Prague | Tschechien | 180 81 | Czechia |
| Brno | 62500 | Czechia |
| Chomutov | 430 01 | Czechia |
| Havlíčkův Brod | 580 01 | Czechia |
| Jihlava | 586 01 | Czechia |
| Kolín | 280 00 | Czechia |
| Pardubice | 530 03 | Czechia |
| Pilsen | 304 60 | Czechia |
| Frederiksberg | 2000 | Denmark |
| Hellerup | 2900 | Denmark |
| Herlev | 2730 | Denmark |
| Hørsholm | DK-2970 | Denmark |
| Silkeborg | 8600 | Denmark |
| Bois-Guillaume | 76230 | France |
| Clermont-Ferrand | 63050 | France |
| Liévin | 62806 | France |
| Marseille | 13008 | France |
| Monaco | 98000 | France |
| Nantes | 44277 | France |
| Nice | 06000 | France |
| Nice | 06002 | France |
| Paris | 75019 | France |
| Paris | 75674 | France |
| Paris | 75877 | France |
| Paris | 75960 | France |
| Soyaux | 16800 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Bad Mergentheim | Baden-Wurttemberg | 97980 | Germany |
| Rheinfelden | Baden-Wurttemberg | 79618 | Germany |
| Fürth | Bavaria | 90766 | Germany |
| Garmisch-Partenkirchen | Bavaria | 82467 | Germany |
| Würzburg | Bavaria | 97080 | 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 |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Witten | North Rhine-Westphalia | 58448 | Germany |
| Beersheba | Israel | 84101 | Israel |
| Haifa | Israel | 31096 | Israel |
| Holon | Israel | 58100 | Israel |
| Kfar Saba | Israel | 44281 | Israel |
| Tel Aviv | Israel | 64239 | Israel |
| Ẕerifin | Israel | 70300 | Israel |
| Tel Litwinsky | 52621 | Israel |
| San Donato Milanese | Milano | 20097 | Italy |
| Abano Terme | Padova | 35031 | Italy |
| Gubbio | Perugia | 06024 | Italy |
| Alghero | Sassari | 07041 | Italy |
| Bologna | 40136 | Italy |
| Florence | 50139 | Italy |
| Lecco | 23900 | Italy |
| Padova | 35127 | Italy |
| Parma | 43100 | Italy |
| Roma | 00168 | Italy |
| Udine | 33100 | Italy |
| Varese | 21100 | Italy |
| Chihuahua, Chih. | Chihuahua | 31000 | Mexico |
| Guadalajara | Jalisco | 44280 | Mexico |
| Hermosillo | Sonora | 83000 | 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 |
| Elverum | 2409 | Norway |
| Gjøvik | 2819 | Norway |
| Kongsvinger | 2212 | Norway |
| Lillehammer | 2609 | Norway |
| Namsos | 7800 | Norway |
| Callao | CALLAO 2 | Peru |
| Lima | LIMA 11 | Peru |
| Lima | LIMA 1 | Peru |
| Bialystok | 15-276 | Poland |
| Bydgoszcz | 85-094 | Poland |
| Gdansk | 80-803 | Poland |
| Krakow | 31-826 | Poland |
| Lodz | 91-002 | Poland |
| Lublin | 20-090 | Poland |
| Lublin | 20-718 | Poland |
| Szczecin | 71-252 | Poland |
| Warsaw | 00-909 | Poland |
| Warsaw | 02-637 | Poland |
| Bloemfontein | Freestate | 9300 | South Africa |
| Johannesburg | Gauteng | 2132 | South Africa |
| Pretoria | Gauteng | 0084 | South Africa |
| Pretoria | Gauteng | PRETORIA | South Africa |
| Pretoria | Gauteng | South Africa |
| Randburg | Gauteng | 2125 | South Africa |
| Durban | KwaZulu-Natal | 4030 | South Africa |
| Newcastle | KwaZulu-Natal | 2940 | South Africa |
| Somerset West | Western Cape | 7130 | South Africa |
| Worcester | Western Cape | 6850 | South Africa |
| Badalona | Barcelona | 08916 | Spain |
| Barcelona | Barcelona | 08006 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Castellon | Castellón de La Plana | 12004 | Spain |
| Jaén | Jaén | 23007 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Pamplona | Pamplona | 31008 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Falköping | 521 85 | Sweden |
| Gothenburg | 416 85 | Sweden |
| Halmstad | 301 85 | Sweden |
| Hässleholm | 281 25 | Sweden |
| Jönköping | 551 85 | Sweden |
| Kungälv | 442 83 | Sweden |
| Lidköping | 531 85 | Sweden |
| Varberg | 432 81 | Sweden |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| 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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