Rivaroxban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00329628
First received: May 24, 2006
Last updated: January 22, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism |
Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
- Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
- Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
- Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 36+/-6 days ] [ Designated as safety issue: No ]
- The composite endpoint comprising major VTE and treatment-emergent major bleeding [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
- Treatment-emergent major bleedings [ Time Frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication ] [ Designated as safety issue: Yes ]
| Enrollment: | 4000 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Rivaroxaban (BAY59-7939)
10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days
|
| Active Comparator: Arm 2 |
Drug: Enoxaparin
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients aged 18 years or above
- Patients scheduled for elective total hip replacement
Exclusion Criteria:
- Planned, staged total bilateral hip replacement
- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329628
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| United States, Alabama | |
| Birmingham, Alabama, United States, 35205 | |
| Northport, Alabama, United States, 35476 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85023 | |
| United States, Arkansas | |
| Benton, Arkansas, United States, 72015 | |
| United States, California | |
| La Jolla, California, United States, 92037 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80012 | |
| United States, Georgia | |
| Decatur, Georgia, United States, 30033 | |
| United States, Montana | |
| Missoula, Montana, United States, 59802 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29414 | |
| United States, Texas | |
| Dallas, Texas, United States, 75231 | |
| Grapevine, Texas, United States, 76051 | |
| Lubbock, Texas, United States, 79410 | |
| San Antonio, Texas, United States, 78233 | |
| Argentina | |
| Avellaneda, Buenos Aires, Argentina, 1870 | |
| Berazategui, Buenos Aires, Argentina, 1884 | |
| Buenos Aires, Capital Federal, Argentina, C1280AEB | |
| Buenos Aires, Capital Federal, Argentina, C1406FWY | |
| Buenos Aires, Capital Federal, Argentina, C1425AGP | |
| Buenos Aires, Capital Federal, Argentina, C1039AAO | |
| Buenos Aires, Capital Federal, Argentina, 1426 | |
| Australia, New South Wales | |
| Sydney, New South Wales, Australia, 2217 | |
| Australia, South Australia | |
| Adelaide, South Australia, Australia, 5042 | |
| Australia, Victoria | |
| Melbourne, Victoria, Australia, 3181 | |
| Melbourne, Victoria, Australia, 3128 | |
| Australia, Western Australia | |
| Fremantle, Western Australia, Australia, 6160 | |
| Austria | |
| Wiener Neustadt, Niederösterreich, Austria, 2700 | |
| Linz, Oberösterreich, Austria, 4020 | |
| Linz, Oberösterreich, Austria, 4010 | |
| Ried, Oberösterreich, Austria, 4910 | |
| Wels, Oberösterreich, Austria, 4600 | |
| Graz, Steiermark, Austria, 8036 | |
| Innsbruck, Tirol, Austria, 6020 | |
| Wien, Austria, 1140 | |
| Belgium | |
| Antwerpen, Belgium, 2020 | |
| Brasschaat, Belgium, 2930 | |
| Brugge, Belgium, 8000 | |
| Genk, Belgium, 3600 | |
| Hasselt, Belgium, 3500 | |
| HUY, Belgium, 4500 | |
| Merksem, Belgium, 2170 | |
| Pellenberg, Belgium, 3212 | |
| Reet, Belgium, 2840 | |
| Roeselare, Belgium, 8800 | |
| Brazil | |
| Porto Alegre, RS, Brazil, 90470 340 | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Rio de Janeiro, Brazil, 20 232 092 | |
| São Paulo, Brazil, 04039-004 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| Kitchener, Ontario, Canada, N2G 1G3 | |
| Oakville, Ontario, Canada, L6J 3L7 | |
| Oshawa, Ontario, Canada, L1J 2J2 | |
| Peterborough, Ontario, Canada, K9J 7C6 | |
| Stratford, Ontario, Canada, N5A 2Y6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Canada | |
| Quebec, Canada, G1L 3L5 | |
| Chile | |
| Santiago, Chile | |
| Colombia | |
| Bogotá, Colombia | |
| Czech Republic | |
| Ceske Budejovice, Czech Republic, 370 87 | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Jindrichuv Hradec, Czech Republic, 377 38 | |
| Karlovy Vary, Czech Republic, 360 66 | |
| Mlada Boleslav, Czech Republic, 293 50 | |
| Olomouc, Czech Republic, 775 20 | |
| Plzen, Czech Republic, 304 60 | |
| Praha 6, Czech Republic, 169 02 | |
| Pribram I, Czech Republic, 261 26 | |
| Prostejov, Czech Republic, 796 04 | |
| Denmark | |
| Frederiksberg, Denmark, 2000 | |
| Hellerup, Denmark, 2900 | |
| Herlev, Denmark, 2730 | |
| Hørsholm, Denmark, DK-2970 | |
| Silkeborg, Denmark, 8600 | |
| Finland | |
| Jyväskylä, Finland, 40620 | |
| Mikkeli, Finland, FIN-50100 | |
| Seinäjoki, Finland, FIN 60220 | |
| France | |
| Bois-guillaume, France, 76230 | |
| Le Chesnay, France, 78150 | |
| Lievin, France, 62806 | |
| Monaco, France, 98000 | |
| Nantes Cedex 2, France, 44277 | |
| Paris, France, 75674 | |
| Paris Cedex 14, France, 75877 | |
| Paris Cedex 19, France, 75019 | |
| Paris Cedex 20, France, 75960 | |
| Saint Herblain, France, 44819 | |
| Soyaux, France, 16800 | |
| Vandoeuvre Les Nancy, France, 54511 | |
| Vannes, France, 56000 | |
| Germany | |
| Bad Mergentheim, Baden-Württemberg, Germany, 97980 | |
| Heidelberg, Baden-Württemberg, Germany, 69112 | |
| Rheinfelden, Baden-Württemberg, Germany, 79618 | |
| Stuttgart, Baden-Württemberg, Germany, 70176 | |
| Fürth, Bayern, Germany, 90766 | |
| Garmisch-Partenkirchen, Bayern, Germany, 82467 | |
| Würzburg, Bayern, Germany, 97080 | |
| Birkenwerder, Brandenburg, Germany, 16547 | |
| Sommerfeld, Brandenburg, Germany, 16766 | |
| Frankfurt, Hessen, Germany, 60528 | |
| Frankfurt, Hessen, Germany, 65929 | |
| Marburg, Hessen, Germany, 35043 | |
| Wiesbaden, Hessen, Germany, 65191 | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18057 | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40225 | |
| Witten, Nordrhein-Westfalen, Germany, 58448 | |
| Dresden, Sachsen, Germany, 01307 | |
| Bremen, Germany, 28205 | |
| Greece | |
| Haidari, Attica, Greece, 12462 | |
| Kifisia, Attica, Greece, 14561 | |
| Hungary | |
| Bekescsaba, Hungary, 5600 | |
| Budapest, Hungary, 1089 | |
| Budapest, Hungary, 1076 | |
| Györ, Hungary, 9024 | |
| Kaposvar, Hungary, 7400 | |
| Kecskemet, Hungary, 6000 | |
| Szeged, Hungary, 6725 | |
| Szekesfehervar, Hungary, 8000 | |
| Szekszard, Hungary, 7100 | |
| Israel | |
| Beer Sheva, Israel, 84101 | |
| Haifa, Israel, 31096 | |
| Holon, Israel, 58100 | |
| Kfar Saba, Israel, 44281 | |
| Petach Tikva, Israel, 49100 | |
| Tel Aviv, Israel, 64239 | |
| Tel Hashomer, Israel, 52621 | |
| Zerifin, Israel, 70300 | |
| Italy | |
| Monza, Milano, Italy, 20052 | |
| Rozzano, Milano, Italy, 20089 | |
| San Donato Milanese, Milano, Italy, 20097 | |
| Gubbio, Perugia, Italy, 06024 | |
| Alghero, Sassari, Italy, 07041 | |
| Busto Arsizio, Varese, Italy, 21052 | |
| Ancona, Italy, 60126 | |
| Bergamo, Italy, 24128 | |
| Bologna, Italy, 40136 | |
| Ferrara, Italy, 44100 | |
| Firenze, Italy, 50139 | |
| Genova, Italy, 16132 | |
| Milano, Italy, 20132 | |
| Milano, Italy, 20162 | |
| Palermo, Italy, 90129 | |
| Reggio Emilia, Italy, 42100 | |
| Roma, Italy, 00168 | |
| Sassari, Italy, 07100 | |
| Torino, Italy, 10126 | |
| Varese, Italy, 21100 | |
| Lithuania | |
| Kaunas, Lithuania, LT-50166 | |
| Vilnius, Lithuania, LT-04130 | |
| Mexico | |
| Monterrey, Nuevo Leon, Mexico, 64380 | |
| Monterrey, Nuevo León, Mexico, 64460 | |
| Edo. de Mexico, Mexico, 53120 | |
| Netherlands | |
| Amsterdam, Netherlands, 1105 AZ | |
| Hilversum, Netherlands, 1213 XZ | |
| Hoofddorp, Netherlands, 2134 TM | |
| Leiden, Netherlands, 2334 CK | |
| Nijmegen, Netherlands, 6522 JV | |
| OSS, Netherlands, 5342 BT | |
| Zwolle, Netherlands, 8011 JW | |
| Norway | |
| Baerum postterminal, Norway, 1306 | |
| Elverum, Norway, 2409 | |
| Gjövik, Norway, 2819 | |
| Lillehammer, Norway, 2609 | |
| Notodden, Norway, NO-3675 | |
| Poland | |
| Bialystok, Poland, 15-276 | |
| Bydgoszcz, Poland, 85-681 | |
| Bydgoszcz, Poland, 85-094 | |
| Gdansk, Poland, 80-803 | |
| Katowice, Poland, 40-635 | |
| Krakow, Poland, 30-901 | |
| Krakow, Poland, 31-826 | |
| Krakow, Poland, 31-913 | |
| Lodz, Poland, 91-002 | |
| Lublin, Poland, 20-718 | |
| Lublin, Poland, 20-090 | |
| Opole, Poland, 45-060 | |
| Poznan, Poland, 60-703 | |
| Sosnowiec, Poland, 41-200 | |
| Szczecin, Poland, 71-252 | |
| Warszawa, Poland, 02-005 | |
| Warszawa, Poland, 00-909 | |
| Warszawa, Poland, 03-242 | |
| Wroclaw, Poland, 51-128 | |
| Slovakia | |
| Bratislava, Slovakia, 826 06 | |
| Kosice - Saca, Slovakia, 040 15 | |
| Zilina, Slovakia, 012 07 | |
| South Africa | |
| Pretoria, Gauteng, South Africa, 0084 | |
| Somerset West, Western Cape, South Africa, 7130 | |
| Worcester, Western Cape, South Africa, 6850 | |
| Spain | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Oviedo, Asturias, Spain, 33006 | |
| Badalona, Barcelona, Spain, 08916 | |
| L'Hospitalet de llobregat, Barcelona, Spain, 08906 | |
| Alcorcón, Madrid, Spain, 28922 | |
| Barcelona, Spain, 08036 | |
| Barcelona, Spain, 08006 | |
| Barcelona, Spain, 08035 | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08025 | |
| Castellón de la Plana, Spain, 12004 | |
| Jaén, Spain, 23007 | |
| Madrid, Spain, 28040 | |
| Pamplona, Spain, 31008 | |
| Valencia, Spain, 46010 | |
| Vitoria, Spain, 01009 | |
| Sweden | |
| Göteborg, Sweden, 416 85 | |
| Halmstad, Sweden, 301 85 | |
| Jönköping, Sweden, 551 85 | |
| Lidköping, Sweden, 531 85 | |
| Varberg, Sweden, 432 81 | |
| Västervik, Sweden, 593 81 | |
| Turkey | |
| Adana, Turkey, 01330 | |
| Istanbul, Turkey, 34093 | |
| Istanbul, Turkey, 34722 | |
| Istanbul, Turkey, 34662 | |
| Izmir, Turkey, 35340 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided by Bayer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00329628 History of Changes |
| Other Study ID Numbers: | 11354, EudraCT: 2005-004351-35 |
| Study First Received: | May 24, 2006 |
| Last Updated: | January 22, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Prevention Thromboembolism |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013