Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients (MAGELLAN)

August 3, 2016 updated by: Bayer

Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Study Type

Interventional

Enrollment (Actual)

8101

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Vicente López, Argentina, 1638
    • Buenos Aires
      • Avellaneda, Buenos Aires, Argentina, B1870CID
      • San Miguel, Buenos Aires, Argentina, 1663
      • Tres de Febrero, Buenos Aires, Argentina, 1657
        • Hospital de Agudos "Dr. Carlos Bocalandro"
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1221
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1280
        • Hospital Británico
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1039AAO
        • Sanatorio Mitre
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1431FWO
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
      • Lismore, New South Wales, Australia, 2480
      • Sydney, New South Wales, Australia, 2229
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
      • Brisbane, Queensland, Australia, 4066
      • Brisbane, Queensland, Australia, 4101
      • Redcliffe, Queensland, Australia, 4020
      • Southport, Queensland, Australia, 4215
      • Woollongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5042
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Clayton, Victoria, Australia, 3168
      • Melbourne, Victoria, Australia, 3135
      • Melbourne, Victoria, Australia, 3144
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Austria
      • Innsbruck, Austria, 6020
      • Linz, Austria, 4020
      • Mürzzuschlag, Austria, 8680
      • St. Pölten, Austria, 3100
      • Wien, Austria, 1030
      • Wien, Austria, 1100
      • Wien, Austria, 1140
    • Burgenland
      • Kittsee, Burgenland, Austria, 2421
      • Oberpullendorf, Burgenland, Austria, 7350
    • Kärnten
      • Wolfsberg, Kärnten, Austria, 9400
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
    • Steiermark
      • Gratwein, Steiermark, Austria, 8113
      • Graz, Steiermark, Austria, 8036
      • Hartberg, Steiermark, Austria, 8230
      • Leoben, Steiermark, Austria, 8700
    • Tirol
      • Zams, Tirol, Austria, 6511
  • Belgium
      • Aalst, Belgium, 9300
      • Brugge, Belgium, 8000
      • Bruxelles - Brussel, Belgium, 1000
      • Dendermonde, Belgium, 9200
      • HUY, Belgium, 4500
      • Hasselt, Belgium, 3500
      • Ieper, Belgium, 8900
      • Leuven, Belgium, 3000
      • MOL, Belgium, 2400
      • Malmedy, Belgium, 4960
      • Montigny S/sambre, Belgium, 6061
      • Mortsel, Belgium, 2640
      • Roeselare, Belgium, 8800
      • Sint-niklaas, Belgium, 9100
      • Tubize, Belgium, 1480
      • Turnhout, Belgium, 2300
  • Brazil
      • Sao Paulo, Brazil, 05403-900
      • Sao Paulo, Brazil, 05443000
    • Parana
      • Curitiba, Parana, Brazil, 80050-350
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 130839 970
      • Santo Andre, Sao Paulo, Brazil, 09190-610
      • São Paulo, Sao Paulo, Brazil, 01323-001
      • São Paulo, Sao Paulo, Brazil, 04039 002
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1606
      • Stara Zagora, Bulgaria, 6000
      • Varna, Bulgaria, 9010
      • Veliko Tarnovo, Bulgaria, 5000
  • Canada
      • Quebec, Canada, G1V 4G5
      • Quebec, Canada, G1J 1Z4
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T5H 3V9
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T6L 5X8
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
    • Ontario
      • Cobourg, Ontario, Canada, K9A 5W6
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Scarborough, Ontario, Canada, M1P 2V5
      • Toronto, Ontario, Canada, M5T 2S8
      • Windsor, Ontario, Canada, N9A 1E1
        • Hotel Dieu-Grace Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Hopital Notre-Dame
      • Montreal, Quebec, Canada, H3T 1M5
      • Montreal, Quebec, Canada, H2L 4M1
      • Montreal, Quebec, Canada, H2W 1T8
      • Ste-Foy, Quebec, Canada, G1V 4G5
  • Chile
      • Santiago, Chile
      • Santiago, Chile, 760 0448
      • Viña del Mar, Chile
  • China
      • Beijing, China, 100044
      • Beijing, China, 100050
      • Beijing, China, 100020
      • Beijing, China, 100029
      • Beijing, China, 100037
      • Beijing, China, 100053
      • Beijing, China, 100088
      • Beijing, China, 100034
      • Beijing, China, 100853
      • Beijing, China, 100005
      • Beijing, China, 100050
        • Beijing Friendship Hosp.
      • Chongqing, China, 400038
      • Chongqing, China, 400042
      • Shanghai, China
      • Shanghai, China, 200127
      • Shanghai, China, 200233
      • Shanghai, China, 200025
      • Shanghai, China, 200003
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
      • Guangzhou, Guangdong, China, 510405
      • Guangzhou, Guangdong, China
    • Hunan
      • Changsha, Hunan, China, 410013
    • Jiangsu
      • Nanjing, Jiangsu, China
      • Nanjing, Jiangsu, China, 210008
    • Jilin
      • Changchun, Jilin, China
    • Liaoning
      • Dalian, Liaoning, China, 116027
      • Shenyang, Liaoning, China, 110001
      • Shenyang, Liaoning, China, 110004
      • Shenyang, Liaoning, China, 110015
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • The 1st Affiliated Hosp of the 4th Military Med Uni
      • Xi'an, Shaanxi, China, 710061
        • 1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.
    • Sichuan
      • Chengdu, Sichuan, China, 610041
  • Colombia
      • Bogota, Colombia
      • Bogotá, Colombia
      • Cali, Colombia
      • Medellín, Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
    • Distrito Capital de Bogotá
      • Bogotá, Distrito Capital de Bogotá, Colombia
    • Valle del Cauca
      • Cali, Valle del Cauca, Colombia
  • Croatia
      • Osijek, Croatia, 310 00
      • Rijeka, Croatia, 51000
      • Zadar, Croatia, 23000
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 1000
  • Czech Republic
      • Brno, Czech Republic, 656 91
      • Kutna Hora, Czech Republic, 284 30
      • Nove Mesto na Morave, Czech Republic, 592 31
      • Olomouc, Czech Republic, 775 20
      • Plzen, Czech Republic, 305 99
      • Praha 2, Czech Republic, 128 08
      • Praha 2, Czech Republic, 128 21
      • Praha 2, Czech Republic, 12808
      • Ricany, Czech Republic, 251 49
      • Znojmo, Czech Republic, 669 02
  • Denmark
      • Esbjerg, Denmark, 6700
      • Frederiksberg C, Denmark, 2000
      • Kolding, Denmark, 6000
      • København NV, Denmark, 2400
      • København S, Denmark, 2300
      • Roskilde, Denmark, 4000
  • Estonia
      • Tallinn, Estonia, 13419
      • Tallinn, Estonia, 10138
      • Tallinn, Estonia, EE-10617
      • Tartu, Estonia, EE-51014
  • Finland
      • Helsinki, Finland, 00290
      • Hämeenlinna, Finland, 13530
      • Jyväskylä, Finland, 40620
      • Lahti, Finland, 15850
      • Lappeenranta, Finland, 53130
      • Raisio, Finland, 21200
      • Turku, Finland, 20520
      • Turku, Finland, 20700
  • France
      • Arras, France, 62000
      • Besancon, France, 25000
      • Brest Cedex, France, 29609
      • Castelnau Le Lez, France, 34170
      • Clermont Ferrand, France, 63000
      • Colombes Cedex, France, 92701
      • Dijon, France, 21000
      • Lille, France, 59037
      • Lille, France, 59307
      • Limoges, France, 87042
      • Lomme, France, 59160
      • Lyon, France, 69003
      • Montpellier Cedex, France, 34295
      • Nice, France, 06280
      • Nimes, France, 30029
      • Paris, France, 75475
      • Paris, France, 75010
      • Paris, France, 75877
      • Paris, France, 75004
      • Pierre Benite, France, 69495
      • Reims, France, 51092
      • Roubaix, France, 59100
      • Saint Herblain Cedex, France, 44805
      • Saint-etienne, France, 42000
      • Strasbourg Cedex, France, 67091
      • TOURCOING cedex, France, 59208
      • Toulouse, France, 31403
      • Vandoeuvre Les Nancy, France, 54511
  • Germany
      • Berlin, Germany, 10787
      • Bremen, Germany, 28177
    • Baden-Württemberg
      • Bad Mergentheim, Baden-Württemberg, Germany, 97980
      • Esslingen, Baden-Württemberg, Germany, 73730
      • Heidelberg, Baden-Württemberg, Germany, 69120
      • Karlsbad, Baden-Württemberg, Germany, 76307
    • Bayern
      • Weiden, Bayern, Germany, 92637
    • Brandenburg
      • Beeskow, Brandenburg, Germany, 15848
      • Frankfurt/Oder, Brandenburg, Germany, 15236
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
      • Jülich, Nordrhein-Westfalen, Germany, 52428
      • Köln, Nordrhein-Westfalen, Germany, 50935
      • Köln, Nordrhein-Westfalen, Germany, 51067
      • Köln, Nordrhein-Westfalen, Germany, 51109
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
      • Neuss, Nordrhein-Westfalen, Germany, 41464
      • Oberhausen, Nordrhein-Westfalen, Germany, 46045
      • Paderborn, Nordrhein-Westfalen, Germany, 33098
      • Soest, Nordrhein-Westfalen, Germany, 59494
      • Stolberg, Nordrhein-Westfalen, Germany, 52222
      • Troisdorf, Nordrhein-Westfalen, Germany, 53844
      • Viersen, Nordrhein-Westfalen, Germany, 41749
      • Wuppertal, Nordrhein-Westfalen, Germany, 42109
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
      • Neuwied, Rheinland-Pfalz, Germany, 56564
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04289
      • Pirna, Sachsen, Germany, 01796
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06112
  • Greece
      • Abelokipi - Athens, Greece, 115 26
      • Athens, Greece, 106 76
      • Athens, Greece, 115 26
      • Athens, Greece, 156 69
      • Nea Ionia, Greece, 14233
      • Piraeus, Greece, 18536
      • Rio / Patras, Greece, 265 04
    • Attica
      • Elefsina, Attica, Greece, 19018
      • Kifisia / Athens, Attica, Greece, 14561
  • Hong Kong
      • Shatin, Hong Kong
    • N.t.
      • Shatin, N.t., Hong Kong
  • Hungary
      • Baja, Hungary, 6500
      • Balassagyarmat, Hungary, 2660
      • Budapest, Hungary, 1134
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1076
      • Debrecen, Hungary, 4012
      • Gyor, Hungary, 9024
      • Hodmezovasarhely, Hungary, 6800
      • Kecskemet, Hungary, 6000
      • Szekesfehervar, Hungary, 8000
      • Tatabanya, Hungary, 2800
      • Zalaegerszeg-Pozva, Hungary, H-8900
  • India
      • Hyderabad, India, 500034
      • Hyderabad, India, 500082
      • Hyderabad, India, 600 038
      • Mumbai, India, 400022
      • Noida, India
    • Gujar?t
      • Ahmedabad, Gujar?t, India, 380 054
    • Karn?taka
      • Bangalore, Karn?taka, India, 560052
      • Bangalore, Karn?taka, India, 560099
    • Kerala
      • Calicut, Kerala, India, 673 004
      • Thiruvananthapuram, Kerala, India, 695002
    • Maharashtra
      • Pune, Maharashtra, India, 411001
      • Pune, Maharashtra, India, 411011
    • Punjab
      • Ludhiana, Punjab, India, 141001
    • Tamil N?du
      • Chennai, Tamil N?du, India, 600081
      • Coimbatore, Tamil N?du, India, 641 004
    • West Bengal
      • Kolkata, West Bengal, India, 700 099
  • Indonesia
      • Jakarta, Indonesia, 10430
      • Jakarta, Indonesia, 11420
      • Surabaya, Indonesia, 60286
  • Israel
      • Afula, Israel, 1834111
      • Ashkelon, Israel, 7830604
      • Haifa, Israel, 3109601
      • Haifa, Israel, 31048
      • Holon, Israel, 58100
      • Kfar Saba, Israel, 4428164
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 64239
      • Zefat, Israel, 1311001
  • Italy
      • Bergamo, Italy, 24128
      • Latina, Italy, 04100
      • Reggio Calabria, Italy, 89124
      • Vicenza, Italy, 36100
    • Bari
      • Acquaviva delle Fonti, Bari, Italy, 70021
    • Campania
      • Napoli, Campania, Italy, 80123
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
      • Parma, Emilia-Romagna, Italy, 43100
      • Piacenza, Emilia-Romagna, Italy, 29121
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
    • Lazio
      • Roma, Lazio, Italy, 00168
      • Roma, Lazio, Italy, 00161
    • Liguria
      • Genova, Liguria, Italy, 16128
    • Lombardia
      • Milano, Lombardia, Italy, 20133
      • Milano, Lombardia, Italy, 20089
      • Milano, Lombardia, Italy, 20162
      • Varese, Lombardia, Italy, 21100
    • Molise
      • Campobasso, Molise, Italy, 86100
    • Parma
      • Fidenza, Parma, Italy, 43036
    • Sicilia
      • Catania, Sicilia, Italy, 95124
      • Palermo, Sicilia, Italy, 90127
    • Trentino-Alto Adige
      • Terni, Trentino-Alto Adige, Italy, 05019
    • Umbria
      • Perugia, Umbria, Italy, 06156
      • Perugia, Umbria, Italy, 06024
    • Verbano-Cusio-Ossola
      • Domodossola, Verbano-Cusio-Ossola, Italy, 28845
  • Japan
      • Fukui, Japan, 910-8561
      • Ibaraki, Japan, 319-1113
        • National Hospital Organization Ibaraki Higashi Hospital
      • Kumamoto, Japan, 860-0008
      • Kyoto, Japan, 606-8507
    • Aichi
      • Ichinomiya, Aichi, Japan, 491-8551
      • Kasugai, Aichi, Japan, 487-0013
      • Obu, Aichi, Japan, 474-8511
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
      • Toon, Ehime, Japan, 791-0281
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8516
    • Gunma
      • Takasaki, Gunma, Japan, 370-0829
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
    • Hokkaido
      • Hakodate, Hokkaido, Japan, 040-8611
      • Sapporo, Hokkaido, Japan, 065-0033
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8511
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8650
    • Iwate
      • Hanamaki, Iwate, Japan, 025-0075
    • Kanagawa
      • Ebina, Kanagawa, Japan, 243-0433
      • Kamakura, Kanagawa, Japan, 247-8533
      • Yokohama, Kanagawa, Japan, 236-0051
    • Kochi
      • Nangoku, Kochi, Japan, 783-8509
    • Mie
      • Matsusaka, Mie, Japan, 515-8544
      • Tsu, Mie, Japan, 514-1101
      • Tsu, Mie, Japan, 514-8507
    • Niigata
      • Kashiwazaki, Niigata, Japan, 945-8585
    • Okinawa
      • Tomigusuku, Okinawa, Japan, 901-0243
      • Urasoe, Okinawa, Japan, 901-2132
    • Osaka
      • Daito, Osaka, Japan, 574-0074
      • Yao, Osaka, Japan, 581-0011
    • Shiga
      • Kusatsu, Shiga, Japan, 525-8585
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8580
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 152-8902
      • Shinjuku-ku, Tokyo, Japan, 162-8655
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-0061
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 463-712
      • Jeollanam-do, Korea, Republic of, 519-763
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 138736
    • Korea
      • Gyeongi-do, Korea, Korea, Republic of, 463-707
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 156-707
        • Seoul Metropolitan Boramae Hospital
  • Latvia
      • Daugavpils, Latvia, LV-5417
      • Liepaja, Latvia, 3402
      • Riga, Latvia, 1002
      • Riga, Latvia, LV-1038
      • Riga, Latvia, 1005
      • Riga, Latvia, LV-1001
      • Valmiera, Latvia, LV-4201
      • Ventspils, Latvia, LV-3601
  • Lithuania
      • Kaunas, Lithuania, LT-3000
      • Kaunas, Lithuania, LT-3002
      • Kaunas, Lithuania, LT-3026
      • Klaipeda, Lithuania, LT-92231
      • Klaipeda, Lithuania, LT-5800
      • Siauliai, Lithuania, 76231
      • Utena, Lithuania, LT-28142
      • Vilnius, Lithuania, LT-2001
      • Vilnius, Lithuania, 10207
      • Vilnius, Lithuania, 04130
  • Luxembourg
      • Kirchberg, Luxembourg, 2540
      • Luxembourg, Luxembourg, 1210
      • Niederkorn, Luxembourg, 4602
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
      • Negeri Sembilan,, Malaysia, 70300
      • Sarawak, Malaysia, 93400
  • Mexico
      • Aguascalientes, Mexico, 20234
      • Chihuahua, Mexico, 31350
      • Puebla, Mexico, 72410
      • Zacatecas, Mexico, 98000
    • Chiapas
      • Tuxtla Gutiérrez, Chiapas, Mexico, 29000
    • Coahuila
      • Torreón, Coahuila, Mexico, 27250
    • Distrito Federal
      • Mexico D. F., Distrito Federal, Mexico, 06760
      • Mexico D.F., Distrito Federal, Mexico, 11340
      • Mexico D.F., Distrito Federal, Mexico, 15900
      • México, D.F, Distrito Federal, Mexico, 07460
      • México, D.F., Distrito Federal, Mexico, 06729
      • México, D.F., Distrito Federal, Mexico, 07760
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
    • Michoacán
      • Morelia, Michoacán, Mexico, 58270
    • México
      • Metepec, México, Mexico, 52140
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 66480
    • Sonora
      • Hermosillo, Sonora, Mexico, 83000
    • Yucatán
      • Mérida, Yucatán, Mexico, 97001
  • Netherlands
      • Amersfoort, Netherlands, 3816 CP
      • Amsterdam, Netherlands, 1061 AE
      • Enschede, Netherlands, 7511 JX
      • Heerlen, Netherlands, 6401 CX
      • Maastricht, Netherlands, 6229 HX
      • Nieuwegein, Netherlands, 3435 CM
      • Rotterdam, Netherlands, 3083 AN
      • Sittard, Netherlands, 6131 BK
      • Utrecht, Netherlands, 3582 KE
  • New Zealand
      • Auckland, New Zealand, 1023
      • Auckland, New Zealand, 2024
      • Auckland, New Zealand, 0622
      • Christchurch, New Zealand, 8011
  • Norway
      • Fredrikstad, Norway, 1603
      • Gjøvik, Norway, 2819
      • Hamar, Norway, 2326
      • Oslo, Norway, 0319
      • Oslo, Norway, 0407
  • Pakistan
      • Karachi, Pakistan, 74800
      • Karachi, Pakistan, 75500
      • Lahore, Pakistan
  • Peru
      • Callao, Peru, CALLAO 2
      • Lima, Peru, 01
      • Lima, Peru, Lima 11
      • Lima, Peru, 31
      • Lima, Peru, Lima 1
      • Lima Cercado, Peru, LIMA 1
  • Poland
      • Bialystok, Poland, 15-276
      • Bydgoszcz, Poland, 85-681
      • Krakow, Poland, 31-066
      • Krakow, Poland, 31-121
      • Lublin, Poland, 20-178
      • Olsztyn, Poland, 10-228
      • Piotrkow Trybunalski, Poland, 97-300
      • Siedlce, Poland, 08-110
      • Starogard Gdanski, Poland, 83-200
      • Szczecin, Poland, 70-965
      • Tarnów, Poland, 33-100
      • Warszawa, Poland, 04-141
      • Warszawa, Poland, 03-401
      • Warszawa, Poland, 04-749
      • Wloclawek, Poland, 87-800
  • Portugal
      • Amadora, Portugal, 2720-276
      • Cascais, Portugal, 2750-349
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1150-199
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1349-019
      • Lisboa, Portugal, 1849- 017
      • Matosinhos, Portugal, 4454-509
      • Porto, Portugal, 4200-319
      • Porto, Portugal, 4099-001
      • Santarém, Portugal, 2005
      • Viana do Castelo, Portugal, 4901-585
    • Coimbra
      • S. Martinho do Bispo, Coimbra, Portugal, 3041-856
  • Romania
      • Bucharest, Romania, 022328
      • Bucharest, Romania, 041915
      • Bucharest, Romania, 014461
      • Constanta, Romania, 900591
      • Suceava, Romania, 720237
  • Russian Federation
      • Moscow, Russian Federation, 125367
      • Moscow, Russian Federation, 115516
      • Moscow, Russian Federation, 125101
      • Moscow, Russian Federation, 119435
      • Moscow, Russian Federation, 119048
      • Moscow, Russian Federation, 117292
      • Moscow, Russian Federation, 103030
      • Moscow, Russian Federation, 115093
      • Nizhny Novgorod, Russian Federation, 603001
      • Nizhny Novgorod, Russian Federation, 603035
      • Yaroslavl, Russian Federation, 150030
      • Yaroslavl, Russian Federation, 150003
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 168752
      • Singapore, Singapore, 308433
  • Slovakia
      • Bratislava, Slovakia, 826 06
      • Bratislava, Slovakia, 813 69
      • Lucenec, Slovakia, 984 39
      • Martin, Slovakia, 036 59
      • Zilina, Slovakia, 012 07
  • Slovenia
      • Golnik, Slovenia, 4204
      • Ljubljana, Slovenia, 1000
      • Novo mesto, Slovenia, 8000
  • South Africa
      • Sandton, Gauteng, South Africa, 2196
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9301
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2132
      • Johannesburg, Gauteng, South Africa, 2196
      • Johannesburg, Gauteng, South Africa, 2057
      • Kempton Park, Gauteng, South Africa, 1610
      • Pretoria, Gauteng, South Africa, 0181
      • Pretoria, Gauteng, South Africa, 0084
      • Pretoria, Gauteng, South Africa, 0157
      • Roodepoort, Gauteng, South Africa, 1724
    • Western Cape
      • Goodwood, Western Cape, South Africa, 7460
      • Somerset West, Western Cape, South Africa, 7130
      • Stellenbosch, Western Cape, South Africa, 7505
      • Worcester, Western Cape, South Africa, 6850
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08023
      • Cuenca, Spain, 16002
      • Córdoba, Spain, 14004
      • Girona, Spain, 17007
      • Zaragoza, Spain, 50009
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • Sabadell, Barcelona, Spain, 08208
    • Córdoba
      • Cabra, Córdoba, Spain, 14940
    • Girona
      • Olot, Girona, Spain, 17800
    • Murcia
      • Cartagena, Murcia, Spain, 30202
    • Málaga
      • Vélez, Málaga, Spain, 29700
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36214
  • Sweden
      • Borås, Sweden, 501 82
      • Hässleholm, Sweden, 281 25
      • Karlshamn, Sweden, 374 80
      • Kristianstad, Sweden, 29185
      • Lund, Sweden, 221 85
      • Malmö, Sweden, 205 02
      • Skövde, Sweden, 541 85
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 182 88
      • Sundsvall, Sweden, 851 86
      • Umeå, Sweden, 90185
      • Visby, Sweden, 62184
  • Switzerland
      • Baden, Switzerland, 5404
      • Bern, Switzerland, 3010
      • Genève, Switzerland, 1211
      • Luzern, Switzerland, 6000
      • Zürich, Switzerland, 8091
    • Basel-Landschaft
      • Bruderholz, Basel-Landschaft, Switzerland, 4101
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
      • Liestal, Basel-Stadt, Switzerland, 4410
    • Bern
      • Langenthal, Bern, Switzerland, 4901
  • Taiwan
      • Kaohsiung, Taiwan, 833
      • Tainan, Taiwan, 710
      • Taipei, Taiwan
      • Taipei, Taiwan, 114
      • Taipei, Taiwan, 10016
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Chiangmai, Thailand, 50200
  • Turkey
      • Istanbul, Turkey, 34098
      • Istanbul, Turkey, 34304
      • Izmir, Turkey, 35100
      • Izmir, Turkey, 35340
  • Ukraine
      • Donetsk, Ukraine, 83003
      • Donetsk, Ukraine, 83045
      • Ivano-Frankivsk, Ukraine, 76000
      • Kharkiv, Ukraine, 61037
      • Kharkiv, Ukraine, 61070
      • Kharkiv, Ukraine, 61178
      • Kiev, Ukraine, 03680
      • Kiev, Ukraine, 02 091
      • Kiev, Ukraine, 04112
      • Kyiv, Ukraine, 01105
      • Lviv, Ukraine, 790 34
      • Odessa, Ukraine, 65009
      • Odessa, Ukraine, 65025
      • Simferopol, Ukraine, 95 026
      • Simferopol, Ukraine, 95023
  • United Kingdom
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, N18 1QX
      • London, United Kingdom, W1T 4EU
      • Nottingham, United Kingdom, NG7 2UH
    • Cleveland
      • Middlesborough, Cleveland, United Kingdom, TS4 3BW
    • Dumfries and Galloway
      • Dumfries, Dumfries and Galloway, United Kingdom, DG1 4EP
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7JU
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G11 6NT
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
      • Birmingham, Alabama, United States, 35235
      • Dothan, Alabama, United States, 36301
      • Geneva, Alabama, United States, 36340
        • Office of Dr. John Simmons, MD
      • Mobile, Alabama, United States, 36608
      • Montgomery, Alabama, United States, 36111
      • Tuscaloosa, Alabama, United States, 35401
      • Tuscaloosa, Alabama, United States, 35406
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Chula Vista, California, United States, 91911
      • Duarte, California, United States, 91010
      • Encinitas, California, United States, 92024
      • Fountain Valley, California, United States, 92708
      • Fullerton, California, United States, 92835
      • Glendale, California, United States, 91206
      • Oceanside, California, United States, 92056
      • Pasadena, California, United States, 91105
      • Redlands, California, United States, 92373
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92120
      • Santa Barbara, California, United States, 93102
      • Torrance, California, United States, 90502-2004
    • Colorado
      • Denver, Colorado, United States, 80204
      • Pueblo, Colorado, United States, 81003
      • Wheat Ridge, Colorado, United States, 80033-6017
    • Connecticut
      • Farmington, Connecticut, United States, 06030
    • Delaware
      • Newark, Delaware, United States, 19718
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Aventura, Florida, United States, 33180
      • Boyton Beach, Florida, United States, 33472
      • Clearwater, Florida, United States, 33756
      • Delray Beach, Florida, United States, 33445
      • Ft. Lauderdale, Florida, United States, 33334
      • Hollywood, Florida, United States, 33021
      • Jupiter, Florida, United States, 33458
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33173-3259
      • Miami Springs, Florida, United States, 33166
      • Pembroke Pines, Florida, United States, 33024
      • Port Charlotte, Florida, United States, 33952
      • Sarasota, Florida, United States, 34232
      • Vero Beach, Florida, United States, 32960
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Decatur, Georgia, United States, 30030
      • Fort Gordon, Georgia, United States, 30905
      • Savannah, Georgia, United States, 31405
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Springfield, Illinois, United States, 62702
    • Indiana
      • Anderson, Indiana, United States, 46011
      • Noblesville, Indiana, United States, 46060
    • Iowa
      • Des Moines, Iowa, United States, 50314-2611
    • Kansas
      • Olathe, Kansas, United States, 66061
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
      • New Orleans, Louisiana, United States, 70121
      • Shreveport, Louisiana, United States, 71130-4228
    • Maine
      • Biddeford, Maine, United States, 04005
      • Rockport, Maine, United States, 04856
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Baltimore, Maryland, United States, 21237
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
      • Grand Rapids, Michigan, United States, 49525
      • Lansing, Michigan, United States, 48910
      • Petoskey, Michigan, United States, 49770-2297
      • Pontiac, Michigan, United States, 48341
      • St. Clair Shores, Michigan, United States, 48081
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
    • Missouri
      • Kansas City, Missouri, United States, 64128
      • St. Louis, Missouri, United States, 63110
      • St. Louis, Missouri, United States, 63141
    • Montana
      • Anaconda, Montana, United States, 59711-2718
      • Great Falls, Montana, United States, 59405
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-1991
      • New Brunswick, New Jersey, United States, 08901
      • Somerville, New Jersey, United States, 08876-2598
      • Summit, New Jersey, United States, 07901
      • Teaneck, New Jersey, United States, 07666
    • New York
      • Brooklyn, New York, United States, 11215
      • Buffalo, New York, United States, 14215-3021
      • Jamaica, New York, United States, 11418
      • New Hyde Park, New York, United States, 11040-1496
      • New York, New York, United States, 10065
      • New York, New York, United States, 10011
      • Stony Brook, New York, United States, 11794
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Elizabeth City, North Carolina, United States, 27909
      • Greensboro, North Carolina, United States, 27403
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Canton, Ohio, United States, 44718
      • Columbus, Ohio, United States, 43215
      • Maumee, Ohio, United States, 43537-1899
      • Toledo, Ohio, United States, 43606
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
      • Camp Hill, Pennsylvania, United States, 17011
      • Danville, Pennsylvania, United States, 17822
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19124
      • Scranton, Pennsylvania, United States, 18510
      • Wilkes-Barre, Pennsylvania, United States, 18711-3752
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Memphis, Tennessee, United States, 38104
      • Nashville, Tennessee, United States, 37232-2650
    • Texas
      • Corsicana, Texas, United States, 75110
      • Dallas, Texas, United States, 75216-7167
      • Edinburg, Texas, United States, 78539
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
      • Houston, Texas, United States, 77030-4009
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78218
    • Utah
      • Ogden, Utah, United States, 84403
    • Virginia
      • Richmond, Virginia, United States, 23298
      • Richmond, Virginia, United States, 23249
    • Washington
      • Everett, Washington, United States, 98201
      • Tacoma, Washington, United States, 98405
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients aged 40 years or more

  • Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

    • Heart failure, New York Heart Association (NYHA) class III or IV
    • Active cancer
    • Acute ischemic stroke
    • Acute infectious and inflammatory diseases, including acute rheumatic diseases
    • Acute respiratory insufficiency
    • Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

  • Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
  • Conditions that may increase the risk of bleeding, including intracranial hemorrhage
  • Required drugs or procedures which may interfere with the study treatment
  • Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
  • General conditions in which subjects are not suitable to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
Drug: Enoxaparin placebo
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Active Comparator: Enoxaparin
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
Drug: Enoxaparin
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
Drug: Rivaroxaban placebo
Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
Time Frame: Up to Day 35 + 6 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 35 + 6 days
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Time Frame: Up to Day 10 + 5 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 10 + 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
Time Frame: Up to Day 35 + 6 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Up to Day 35 + 6 days
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population
Time Frame: Up to Day 10 + 5 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 10 + 5 days
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
Time Frame: Up to Day 10 + 5 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Up to Day 10 + 5 days
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
Time Frame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days
Time Frame: Up to Day 35 + 6 days
Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.
Up to Day 35 + 6 days
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days
Time Frame: Up to Day 10 + 5 days
Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events
Up to Day 10 + 5 days
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Time Frame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
Time Frame: Up to Day 35 + 6 days
The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 35 + 6 days
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Time Frame: Up to Day 10 + 5 days
The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 10 + 5 days
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
Time Frame: Up to Day 90 + 7 days
All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.
Up to Day 90 + 7 days
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)
Time Frame: Up to Day 35 + 6 days
Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding
Up to Day 35 + 6 days
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)
Time Frame: Up to Day 10 + 5 days
Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.
Up to Day 10 + 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12839
  • 2007-004614-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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