Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities (VOYAGER PAD)

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Rivaroxaban-Placebo

• Study Type: Interventional
• Enrollment (Actual): 6564
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Auton. de Buenos Aires, Argentina, C1181ACL
  • Corrientes, Argentina, 3400
  • Córdoba, Argentina, 5000
  • Córdoba, Argentina, X5006IKK
  • Córdoba, Argentina, X5000AAX
  • Santa Fe, Argentina, S3000FWO
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, B8001HXM
    • Ciudadela, Buenos Aires, Argentina, 1702
    • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
    • Junín, Buenos Aires, Argentina, B6000BHA
    • La Plata, Buenos Aires, Argentina, 1900
    • La Plata, Buenos Aires, Argentina, B1900ASM
    • Mar del Plata, Buenos Aires, Argentina, 7600
    • San Isidro, Buenos Aires, Argentina, B1642DCD
    • San Martín, Buenos Aires, Argentina, 1650
  • Ciudad Auton. De Buenos Aires
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, 1078
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1428ART
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1119ACN
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1280AEB
  • La Pampa
    • Santa Rosa, La Pampa, Argentina, 6300
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
    • Rosario, Santa Fe, Argentina, S2000PBJ
    • Rosario, Santa Fe, Argentina, S2000QID
• Austria
  • Linz, Austria, 4021
  • Wien, Austria, 1160
  • Wien, Austria, 1090
  • Wien, Austria, 1140
  • Wien, Austria, 1170
  • Kärnten
    • Klagenfurt, Kärnten, Austria, 9020
  • Steiermark
    • Graz, Steiermark, Austria, 8036
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6807
• Belgium
  • Bruxelles - Brussel, Belgium, 1070
  • Bruxelles - Brussel, Belgium, 1200
  • Bruxelles - Brussel, Belgium, 1090
  • Genk, Belgium, 3600
  • Gent, Belgium, 9000
  • Kortrijk, Belgium, 8500
  • Leuven, Belgium, 3000
• Brazil
  • Rio de Janeiro, Brazil, 20551-030
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430 370
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30140-062
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
    • Belo Horizonte, Minas Gerais, Brazil, 30110-090
    • Belo Horizonte, Minas Gerais, Brazil, 30140-073
    • Uberlândia, Minas Gerais, Brazil, 38411-186
  • Parana
    • Curitiba, Parana, Brazil, 80230-130
  • Rio Grande Do Sul
    • Canoas, Rio Grande Do Sul, Brazil, 92200-000
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
    • Porto Alegre, Rio Grande Do Sul, Brazil
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90619900
  • Sao Paulo
    • Belo Horizonte, Sao Paulo, Brazil, 30110-130
    • Campinas, Sao Paulo, Brazil, 13060-080
    • Santo André, Sao Paulo, Brazil, 09030-010
    • São Bernardo do Campo, Sao Paulo, Brazil, 09715-090
    • São José do Rio Preto, Sao Paulo, Brazil, 15090
    • São Paulo, Sao Paulo, Brazil, 01323-903
    • Tatui, Sao Paulo, Brazil, 18270-170
• Bulgaria
  • Burgas, Bulgaria, 8000
  • Panagyurishte, Bulgaria, 4500
  • Plovdiv, Bulgaria, 4002
  • Ruse, Bulgaria, 7002
  • Ruse, Bulgaria, 7013
  • Samokov, Bulgaria, 2000
  • Sofia, Bulgaria, 1431
  • Sofia, Bulgaria, 1606
  • Sofia, Bulgaria, 1309
  • Sofia, Bulgaria, 1407
  • Stara Zagora, Bulgaria, 6000
  • Varna, Bulgaria, 9010
  • Yambol, Bulgaria, 8600
• Canada
  • Montreal, Quebec, Canada, H4A 3J1
  • Quebec, Canada, G1L 3L5
  • Vancouver, Canada, V5Z 1M9
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H6
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
    • London, Ontario, Canada, ON N6A 5W9
    • Ottawa, Ontario, Canada, K1Y 4E9
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
    • Gatineau, Quebec, Canada, J8Y 6S8
    • Montreal, Quebec, Canada, H1T 2M4
    • Montreal, Quebec, Canada, H3T 1E2
    • Montreal, Quebec, Canada, H1T 1C8
    • Montreal, Quebec, Canada, H2W 1T8
    • St. Jerome, Quebec, Canada, J7Z 5T3
• China
  • Beijing, China, 100730
  • Beijing, China, 100029
  • Beijing, China, 100053
  • Beijing, China, 100083
  • Beijing, China, 100853
  • Beijing, China, 100144
  • Shanghai, China, 200032
  • Shanghai, China, 200040
  • Tianjin, China, 300000
  • Anhui
    • Hefei, Anhui, China, 230001
  • Chongqing
    • Chongqing, Chongqing, China
  • Fujian
    • Fuzhou, Fujian, China, 350025
    • Zhangzhou, Fujian, China, 363000
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
    • Guangzhou, Guangdong, China
    • Guangzhou, Guangdong, China, 510630
    • Zhanjiang, Guangdong, China, 524001
    • Zhongshan, Guangdong, China, 528403
  • Hainan
    • Haikou, Hainan, China, 570311
  • Hubei
    • Wuhan, Hubei, China, 430014
    • Wuhan, Hubei, China, 430030
  • Hunan
    • Changsha, Hunan, China, 410011
    • Changsha, Hunan, China, 410008
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
    • Nanjing, Jiangsu, China, 210006
  • Jilin
    • Changchun, Jilin, China, 130021
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
  • Shandong
    • Qingdao, Shandong, China, 266003
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
  • Zhejiang
    • Taizhou, Zhejiang, China, 317000
    • Wenzhou, Zhejiang, China, 325000
• Czechia
  • Brno, Czechia, 656 91
  • Hodonin, Czechia, 69501
  • Hradec kralove, Czechia, 500 05
  • Kladno, Czechia, 27259
  • Liberec, Czechia, 460 63
  • Olomouc, Czechia, 775 20
  • Plzen, Czechia, 30599
  • Praha 10, Czechia, 10100
  • Praha 2, Czechia, 12808
  • Praha 5, Czechia, 150 06
  • Praha 5, Czechia, 15006
  • Prostejov, Czechia, 798 11
  • Vratimov, Czechia, 73932
• Denmark
  • Aarhus N, Denmark, 8200
  • Kolding, Denmark, 6000
  • København Ø, Denmark, 2100
  • Odense C, Denmark, 5000
  • Viborg, Denmark, 8800
• Estonia
  • Tallin, Estonia, 11312
  • Tallinn, Estonia, 13419
  • Tartu, Estonia, 50406
• Finland
  • Helsinki, Finland, 00290
  • Oulu, Finland, 90220
  • Tampere, Finland, 33521
• France
  • Bordeaux, France, 33000
  • Bordeaux, France, 33075
  • Caen Cedex, France, 14033
  • Castelnau Le Lez, France, 34170
  • Grenoble, France, 38043
  • Le Coudray, France, 28630
  • Limoges, France, 87042
  • Montpellier Cedex, France, 34295
  • Nice, France, 06280
  • POITIERS cedex, France, 86021
  • Paris, France, 75634
  • Paris Cedex 15, France, 75908
  • Rennes Cedex, France, 35033
  • Strasbourg, France, 67091
  • Toulouse, France, 31403
  • Toulouse, France, 31300
• Germany
  • Berlin, Germany, 10787
  • Berlin, Germany, 10713
  • Bremen, Germany, 28277
  • Dresden, Germany, 01067
  • Hamburg, Germany, 20246
  • Baden-Württemberg
    • Bad Friedrichshall, Baden-Württemberg, Germany, 74177
    • Bad Krozingen, Baden-Württemberg, Germany, 79189
    • Freudenstadt, Baden-Württemberg, Germany, 72250
    • Heidelberg, Baden-Württemberg, Germany, 69129
    • Karlsbad, Baden-Württemberg, Germany, 76307
    • Karlsruhe, Baden-Württemberg, Germany, 76133
    • Ulm, Baden-Württemberg, Germany, 89081
  • Bayern
    • Erlangen, Bayern, Germany, 91054
    • Immenstadt, Bayern, Germany, 87509
    • München, Bayern, Germany, 80336
    • München, Bayern, Germany, 81675
    • München, Bayern, Germany, 80331
    • Regensburg, Bayern, Germany, 93053
    • Rosenheim, Bayern, Germany, 83022
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
    • Darmstadt, Hessen, Germany, 64276
    • Frankfurt, Hessen, Germany, 65929
    • Frankfurt, Hessen, Germany, 60596
    • Frankfurt, Hessen, Germany, 60389
  • Nordrhein-Westfalen
    • Arnsberg, Nordrhein-Westfalen, Germany, 59759
    • Bielefeld, Nordrhein-Westfalen, Germany, 33604
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    • Krefeld, Nordrhein-Westfalen, Germany, 47805
    • Köln, Nordrhein-Westfalen, Germany, 50937
    • Münster, Nordrhein-Westfalen, Germany, 48149
    • Wesel, Nordrhein-Westfalen, Germany, 46483
  • Rheinland-Pfalz
    • Kaiserslautern, Rheinland-Pfalz, Germany, 67657
    • Mainz, Rheinland-Pfalz, Germany, 55131
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
    • Dresden, Sachsen, Germany, 01099
    • Leipzig, Sachsen, Germany, 04103
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
  • Thüringen
    • Jena, Thüringen, Germany, 07740
    • Sonneberg, Thüringen, Germany, 96515
• Hungary
  • Budapest, Hungary, 1115
  • Budapest, Hungary, 1085
  • Budapest, Hungary, 1106
  • Debrecen, Hungary, 4032
  • Gyor, Hungary, 9023
  • Kaposvar, Hungary, 7400
  • Kistarcsa, Hungary, 2143
  • Miskolc, Hungary, 3526
  • Nyiregyhaza, Hungary, 4400
  • Pecs, Hungary, 7624
  • Szeged, Hungary, 6725
  • Szekesfehervar, Hungary, 8000
  • Szombathely, Hungary, 9700
• Italy
  • Basilicata
    • Potenza, Basilicata, Italy, 85100
  • Campania
    • Avellino, Campania, Italy, 83100
    • Napoli, Campania, Italy, 80131
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
    • Ravenna, Emilia-Romagna, Italy, 48033
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
  • Lazio
    • Roma, Lazio, Italy, 00161
  • Lombardia
    • Milano, Lombardia, Italy, 20132
    • Varese, Lombardia, Italy, 21100
  • Marche
    • Macerata, Marche, Italy, 62100
  • Piemonte
    • Torino, Piemonte, Italy, 10126
  • Puglia
    • Lecce, Puglia, Italy, 73100
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
    • Ragusa, Sicilia, Italy, 97100
  • Toscana
    • Firenze, Toscana, Italy, 50134
  • Umbria
    • Perugia, Umbria, Italy, 06132
• Japan
  • Gifu, Japan, 500-8717
  • Kagoshima, Japan, 890-8760
  • Kumamoto, Japan, 860-0008
  • Kyoto, Japan, 615-8256
  • Kyoto, Japan, 604-8401
  • Miyazaki, Japan, 880-2102
  • Osaka, Japan, 530-8480
  • Osaka, Japan, 558-8558
  • Osaka, Japan, 530-0012
  • Saitama, Japan, 336-8522
  • Shizuoka, Japan, 420-8630
  • Aichi
    • Nagakute, Aichi, Japan, 480-1195
  • Ehime
    • Matsuyama, Ehime, Japan, 790-8524
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
    • Kitakyushu, Fukuoka, Japan, 805-0050
    • Kurume, Fukuoka, Japan, 830-8577
  • Gunma
    • Shibukawa, Gunma, Japan, 377-0061
  • Hiroshima
    • Hatsukaichi, Hiroshima, Japan, 738-8503
  • Hokkaido
    • Asahikwa, Hokkaido, Japan, 078-8510
    • Sapporo, Hokkaido, Japan, 060-0031
    • Sapporo, Hokkaido, Japan, 064-8622
    • Tomakomai, Hokkaido, Japan, 053-8506
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-8511
    • Himeji, Hyogo, Japan, 670-0981
    • Himeji, Hyogo, Japan, 671-1227
    • Kobe, Hyogo, Japan, 650-0047
    • Kobe, Hyogo, Japan, 651-0053
    • Takarazuka, Hyogo, Japan, 665-0873
  • Iwate
    • Morioka, Iwate, Japan, 020-0066
  • Kagawa
    • Takamatsu, Kagawa, Japan, 760-8557
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 215-0026
    • Sagamihara, Kanagawa, Japan, 252-5188
  • Mie
    • Matsusaka, Mie, Japan, 515-8566
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
  • Nara
    • Kashihara, Nara, Japan, 634-8522
  • Oita
    • Beppu, Oita, Japan, 874-0011
  • Osaka
    • Habikino, Osaka, Japan, 583-0872
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
  • Shiga
    • Omihachiman, Shiga, Japan, 523-0082
  • Shimane
    • Hamada, Shimane, Japan, 697-8511
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
    • Fuchu, Tokyo, Japan, 183-0003
    • Itabashi-ku, Tokyo, Japan, 173-8610
    • Itabashi-ku, Tokyo, Japan, 173-0015
    • Meguro-ku, Tokyo, Japan, 152-8902
    • Minato, Tokyo, Japan, 108-0073
    • Minato-ku, Tokyo, Japan, 108-8329
    • Suginami-ku, Tokyo, Japan, 166-0001
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
  • Daegu, Korea, Republic of, 700-712
  • Daegu, Korea, Republic of, 42472
  • Daejeon, Korea, Republic of, 301-723
  • Jung-gu Daejeon, Korea, Republic of, 35015
  • Seoul, Korea, Republic of, 137-701
  • Seoul, Korea, Republic of
  • Seoul, Korea, Republic of, 06351
  • Seoul, Korea, Republic of, 03722
  • Seoul, Korea, Republic of, 152-703
  • Seoul, Korea, Republic of, 05368
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10326
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
  • Incheon Gwang''yeogsi
    • Incheon, Incheon Gwang''yeogsi, Korea, Republic of, 21565
• Latvia
  • Daugavpils, Latvia, LV-5417
  • Liepaja, Latvia, LV-3414
  • Riga, Latvia, LV-1002
  • Riga, Latvia, 1038
• Lithuania
  • Kaunas, Lithuania, 45130
  • Kaunas, Lithuania, LT-50009
  • Panevezys, Lithuania, 35144
  • Vilnius, Lithuania, LT-08661
  • Vilnius, Lithuania, LT-10207
• Netherlands
  • Den Bosch, Netherlands, 5223 GZ
  • Eindhoven, Netherlands, 5623 EJ
  • Enschede, Netherlands, 7611 JH
  • Heerlen, Netherlands, 6419 PC
  • Utrecht, Netherlands, 3584 CX
  • Veldhoven, Netherlands, 5504 DB
  • Zwolle, Netherlands, 8025 AB
• Poland
  • Bialystok, Poland, 15_111
  • Bydgoszcz, Poland, 85-094
  • Gdynia, Poland, 81-338
  • Katowice, Poland, 40-040
  • Krakow, Poland
  • Lodz, Poland, 94-048
  • Lublin, Poland, 20-044
  • Lublin, Poland, 20-718
  • Poznan, Poland, 61-848
  • Szczecin, Poland, 70-111
  • Warszawa, Poland, 02-097
  • Warszawa, Poland, 01-211
  • Warszawa, Poland, 01-868
  • Wroclaw, Poland, 50-981
• Portugal
  • Lisboa, Portugal, 1169-1024
  • Ponta Delgada, Portugal, 9500-370
  • Porto, Portugal, 4200-319
  • Porto, Portugal, 4099-001
  • Vila Nova de Gaia, Portugal, 4434-502
  • Setúbal
    • Almada, Setúbal, Portugal, 2805-267
• Romania
  • Bucharest, Romania, 011461
  • Bucharest, Romania, 022322
  • Bucharest, Romania, 010192
  • Cluj Napoca, Romania, 400001
  • Iasi, Romania, 700732
  • Oradea, Romania
  • Targu Mures, Romania, 540124
  • Timisoara, Romania, 300736
  • Arges
    • Pitesti, Arges, Romania, 110084
• Russian Federation
  • Kemerovo, Russian Federation, 650002
  • Moscow, Russian Federation, 115682
  • Moscow, Russian Federation, 117997
  • Moscow, Russian Federation, 129327
  • Moscow, Russian Federation, 105077
  • Nizhny Novgorod, Russian Federation, 603155
  • Novosibirsk, Russian Federation, 630055
  • Novosibirsk, Russian Federation, 630087
  • Rostov-on-Don, Russian Federation, 344022
  • Ryazan, Russian Federation, 390026
  • Saint-Petersburg, Russian Federation, 197374
  • St. Petersburg, Russian Federation, 194354
  • St. Petersburg, Russian Federation, 195271
  • St. Petersburg, Russian Federation, 194291
  • St. Petersburg, Russian Federation, 191015
  • Tomsk, Russian Federation, 634012
  • Tver, Russian Federation, 170036
  • Voronezh, Russian Federation, 394066
• Serbia
  • Belgrade, Serbia, 11000
  • Belgrade, Serbia, 11040
  • Belgrade, Serbia, 11080
  • Beograd, Serbia, 11000
  • Nis, Serbia, 18000
• Slovakia
  • Bardejov, Slovakia, 085 01
  • Bratislava, Slovakia, 851 07
  • Bratislava, Slovakia, 83348
  • Bratislava 37, Slovakia, 833 48
  • Dunajska Streda, Slovakia, 92901
  • Kosice, Slovakia, 04001
  • Nitra, Slovakia, 949 01
  • Nove Zamky, Slovakia, 940 01
  • Trnava, Slovakia, 91701
  • Zilina, Slovakia, 01001
• Spain
  • A Coruña, Spain, 15006
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08035
  • Ciudad Real, Spain, 13005
  • Granada, Spain, 18012
  • Madrid, Spain, 28006
  • Pamplona, Spain, 31008
  • Tarragona, Spain, 43005
  • Andalucía
    • Cádiz, Andalucía, Spain, 11009
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Sabadell, Barcelona, Spain, 08208
• Sweden
  • Göteborg, Sweden, 413 46
  • Linköping, Sweden, 582 85
  • Malmö, Sweden, 205 02
  • Solna, Sweden, 171 76
  • Växjö, Sweden, 351 85
• Switzerland
  • Baden, Switzerland, 5404
  • Bern, Switzerland, 3010
  • Fribourg, Switzerland, 1700
  • Genève, Switzerland, 1205
  • Luzern, Switzerland, 6000
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
  • Graubünden
    • Chur, Graubünden, Switzerland, 7000
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
• Taiwan
  • Hsinchu City, Taiwan, 300
  • Kaohsiung, Taiwan, 813
  • Kaohsiung, Taiwan, 82445
  • Tainan, Taiwan, 704
  • Taipei, Taiwan, 11217
  • Taipei, Taiwan, 10002
  • Taoyuan, Taiwan, 333423
• Thailand
  • Bangkok, Thailand
  • Bangkok, Thailand, 10400
  • Bangkok, Thailand, 10700
  • Bangkok, Thailand, 10330
  • Khon Kaen, Thailand, 40002
  • Songkla, Thailand, 90110
• Ukraine
  • Dnipro, Ukraine, 49000
  • Ivano-Frankivsk, Ukraine, 76000
  • Ivano-Frankivsk, Ukraine, 76014
  • Kharkiv, Ukraine, 61018
  • Kiev, Ukraine, 3680
  • Kyiv, Ukraine, 1601
  • Lviv, Ukraine, 79010
  • Vinnytsia, Ukraine, 21018
  • Zaporizhzhya, Ukraine, 69600
• United Kingdom
  • Cambridge, United Kingdom, CB3 OLB
  • Cheltenham, United Kingdom, GL53 7AN
  • London, United Kingdom, W6 8RF
  • London, United Kingdom, NW3 2QG
  • London, United Kingdom, SW17 0QT
  • Manchester, United Kingdom, M13 9WL
  • Manchester, United Kingdom, M23 9LT
  • Sheffield, United Kingdom, S5 7AU
  • Cumbria
    • Carlisle, Cumbria, United Kingdom, CA2 7HY
  • Humberside
    • Hull, Humberside, United Kingdom, HU3 2JZ
  • London
    • Harrow, London, United Kingdom, HA1 3UJ
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B9 5SS
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
  • Worcestershire
    • Worcester, Worcestershire, United Kingdom, WR5 1DD
• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
    • Birmingham, Alabama, United States, 35294-0012
    • Fort Payne, Alabama, United States, 35967
    • Huntsville, Alabama, United States, 35801-4317
  • Arizona
    • Avondale, Arizona, United States, 85388
    • Glendale, Arizona, United States, 85340
    • Phoenix, Arizona, United States, 85006
  • California
    • Mission Viejo, California, United States, 92691
    • Northridge, California, United States, 91325
    • Palo Alto, California, United States, 94304
    • Roseville, California, United States, 95661
    • Stanford, California, United States, 94305
    • Torrance, California, United States, 90502
  • Colorado
    • Aurora, Colorado, United States, 80045
    • Denver, Colorado, United States, 80220
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
    • Washington, District of Columbia, United States, 20422
  • Florida
    • Atlantis, Florida, United States, 33462
    • Clearwater, Florida, United States, 33756
    • Daytona Beach, Florida, United States, 32117
    • Gainesville, Florida, United States, 32605
    • Hudson, Florida, United States, 34667
    • Jacksonville, Florida, United States, 32209
    • Jacksonville, Florida, United States, 32216
    • Miami, Florida, United States, 33173
    • Ocala, Florida, United States, 34474
    • Pensacola, Florida, United States, 32501
    • Safety Harbor, Florida, United States, 34695
    • Tallahassee, Florida, United States, 32308
    • Wellington, Florida, United States, 33449
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
    • Elk Grove Village, Illinois, United States, 60007
    • Springfield, Illinois, United States, 62702
    • Springfield, Illinois, United States, 62701
    • Urbana, Illinois, United States, 61801
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
    • Fort Wayne, Indiana, United States, 46845
    • Merrillville, Indiana, United States, 46410
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kentucky
    • Lexington, Kentucky, United States, 40536
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
    • Covington, Louisiana, United States, 70433
    • Shreveport, Louisiana, United States, 71103
    • Shreveport, Louisiana, United States, 71105
  • Maine
    • Lewiston, Maine, United States, 04240
  • Maryland
    • Baltimore, Maryland, United States, 21218
    • Baltimore, Maryland, United States, 21201-1595
    • Clinton, Maryland, United States, 20735
  • Michigan
    • Bay City, Michigan, United States, 48708
    • Dearborn, Michigan, United States, 48126
    • Detroit, Michigan, United States, 48201
    • Lansing, Michigan, United States, 48912
    • Midland, Michigan, United States, 48670
    • Muskegon, Michigan, United States, 49444
    • Wyoming, Michigan, United States, 49519
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
    • Saint Cloud, Minnesota, United States, 56303
  • Mississippi
    • Jackson, Mississippi, United States, 39216
    • Tupelo, Mississippi, United States, 38801
  • Missouri
    • Saint Louis, Missouri, United States, 63128
    • Springfield, Missouri, United States, 65807
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
    • Lincoln, Nebraska, United States, 68510
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
  • New Jersey
    • Flemington, New Jersey, United States, 08822
    • Linden, New Jersey, United States, 07036
    • Teaneck, New Jersey, United States, 07666
  • New York
    • New York, New York, United States, 10011
    • New York, New York, United States, 10029
    • Saratoga Springs, New York, United States, 12866
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
    • Charlotte, North Carolina, United States, 28204
    • Durham, North Carolina, United States, 27710
    • Winston-Salem, North Carolina, United States, 27103
  • North Dakota
    • Minot, North Dakota, United States, 58701
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Cincinnati, Ohio, United States, 45267
    • Dayton, Ohio, United States, 45414
    • Springfield, Ohio, United States, 45505
    • Toledo, Ohio, United States, 43614
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
  • Oregon
    • Hillsboro, Oregon, United States, 97123
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
    • Erie, Pennsylvania, United States, 16507
    • Philadelphia, Pennsylvania, United States, 19104
    • Philadelphia, Pennsylvania, United States, 19140
    • York, Pennsylvania, United States, 17405
  • South Carolina
    • Greenville, South Carolina, United States, 29657
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
  • Texas
    • Amarillo, Texas, United States, 79106
    • Austin, Texas, United States, 78705
    • Dallas, Texas, United States, 75226
    • Dallas, Texas, United States, 75216-7167
    • Edinburg, Texas, United States, 78539
    • Houston, Texas, United States, 77030
    • Humble, Texas, United States, 77338
    • Huntsville, Texas, United States, 77340
    • Kingwood, Texas, United States, 77339
    • San Antonio, Texas, United States, 78258
    • Tyler, Texas, United States, 75701
    • Victoria, Texas, United States, 77901
  • Wisconsin
    • Madison, Wisconsin, United States, 53713
    • Manitowoc, Wisconsin, United States, 54220
    • Wausau, Wisconsin, United States, 54401

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥50
• Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
• Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization

Exclusion Criteria:

• Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
• Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
• Prior revascularization on the index leg within 10 days of the qualifying revascularization.
• Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for >6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
• Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban; Rivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)	Drug: Rivaroxaban (Xarelto, BAY59-7939); 2.5 mg, twice daily, orally, tablet
Placebo Comparator: Placebo; Rivaroxaban-placebo orally twice daily	Drug: Rivaroxaban-Placebo; matching placebo, twice daily, orally, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.
Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.
Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.
Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days
Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days
Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days
Number of Mortality (All-cause)		For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 days
Number of Participants With Venous Thromboembolic (VTE) Events	Venous thromboembolic events were reported by investigator only.	For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 days
Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.	For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).
Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered	For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC; Colorado Prevention Center

Publications and helpful links

General Publications

• Hess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.
• Hogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.
• Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.
• Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.
• Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.
• Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.
• Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.
• Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2015
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Aspirin; Rivaroxaban; Peripheral arterial disease; Revascularization; Peripheral artery disease; Amputation; Anticoagulant; Cardiovascular events; Xarelto; Acute limb ischemia; Acetylic salicylic acid
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 17454; 2014-005569-58 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No