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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504216
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
Janssen Research & Development, LLC
Colorado Prevention Center
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of study is to test whether rivaroxaban added to standard of care treatment, when compared to placebo, has 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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Rivaroxaban-Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 18, 2015
Estimated Primary Completion Date : November 22, 2019
Estimated Study Completion Date : January 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

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




Primary Outcome Measures :
  1. Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  2. Time from randomization to first occurrence of major bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) classification [ Time Frame: Approximately 2 years ]
    To evaluate the overall safety and tolerability.


Secondary Outcome Measures :
  1. Time from randomization to first occurrence of myocardial infarction, ischemic stroke, coronary heart disease mortality, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  2. Time from randomization to first occurrence of an unplanned index limb revascularization for recurrent limb ischemia [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  3. Time from randomization to first occurrence of hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  4. Time from randomization to the first occurrence of MI, ischemic stroke, all-cause mortality, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  5. Time from randomization to first occurrence of myocardial infarction, all-cause stroke, cardiovascular death, acute limb ischemia, and major amputation of a vascular etiology [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  6. Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.

  7. Time from randomization to first occurrence of venous thromboembolic (VTE) events [ Time Frame: Approximately 2 years ]
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504216


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Locations
Layout table for location information
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
United States, Arizona
Avondale, Arizona, United States, 85388
Glendale, Arizona, United States, 85340
Phoenix, Arizona, United States, 85006
United States, 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
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80220
United States, District of Columbia
Washington, District of Columbia, United States, 20007
Washington, District of Columbia, United States, 20422
United States, 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
Tallahassee, Florida, United States, 32308
Wellington, Florida, United States, 33449
United States, Illinois
Arlington Heights, Illinois, United States, 60005
Elk Grove Village, Illinois, United States, 60007
Springfield, Illinois, United States, 62072
Springfield, Illinois, United States, 62701
Urbana, Illinois, United States, 61801
United States, Indiana
Fort Wayne, Indiana, United States, 46804
Fort Wayne, Indiana, United States, 46845
Merrillville, Indiana, United States, 46410
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Alexandria, Louisiana, United States, 71301
Covington, Louisiana, United States, 70433
Shreveport, Louisiana, United States, 71103
Shreveport, Louisiana, United States, 71105
United States, Maine
Auburn, Maine, United States, 04240
United States, Maryland
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21218
Clinton, Maryland, United States, 20735
United States, Michigan
Bay City, Michigan, United States, 48708
Dearborn, Michigan, United States, 48126
Detroit, Michigan, United States, 48201-2018
Lansing, Michigan, United States, 48912
Midland, Michigan, United States, 48670
Muskegon, Michigan, United States, 49444
Wyoming, Michigan, United States, 49519
United States, Minnesota
Minneapolis, Minnesota, United States, 55433
Saint Cloud, Minnesota, United States, 56303
United States, Mississippi
Jackson, Mississippi, United States, 39216
Tupelo, Mississippi, United States, 38801
United States, Missouri
Saint Louis, Missouri, United States, 63128
Springfield, Missouri, United States, 65807
United States, Nebraska
Lincoln, Nebraska, United States, 68506
Lincoln, Nebraska, United States, 68510
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Flemington, New Jersey, United States, 08822
Linden, New Jersey, United States, 07036
Teaneck, New Jersey, United States, 07666
United States, New York
New York, New York, United States, 10011
New York, New York, United States, 10029
Saratoga Springs, New York, United States, 12866
United States, 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
United States, North Dakota
Minot, North Dakota, United States, 58701
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45267-0564
Dayton, Ohio, United States, 45414
Springfield, Ohio, United States, 45505
Toledo, Ohio, United States, 43614
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73135
United States, Oregon
Hillsboro, Oregon, United States, 97123
United States, 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
United States, South Carolina
Greenville, South Carolina, United States, 29657
United States, South Dakota
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Knoxville, Tennessee, United States, 37934
United States, Texas
Amarillo, Texas, United States, 79106
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75216-7167
Dallas, Texas, United States, 75226
Edinburg, Texas, United States, 78539
Houston, Texas, United States, 77030
Kingwood, Texas, United States, 77339
Palestine, Texas, United States, 75801
San Antonio, Texas, United States, 78258
Tyler, Texas, United States, 75701
Victoria, Texas, United States, 77901
United States, Wisconsin
Madison, Wisconsin, United States, 53713
Manitowoc, Wisconsin, United States, 54220
Wausau, Wisconsin, United States, 54401
Argentina
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, B1900AVG
Mar del Plata, Buenos Aires, Argentina, 7600
San Isidro, Buenos Aires, Argentina, B1642DCD
San Martín, Buenos Aires, Argentina, 1650
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, 1078
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1119ACN
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1280AEB
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1428ART
Santa Rosa, La Pampa, Argentina, 6300
Rosario, Santa Fe, Argentina, 2000
Rosario, Santa Fe, Argentina, S2000PBJ
Rosario, Santa Fe, Argentina, S2000QID
Ciudad Auton. de Buenos Aires, Argentina, C1181ACL
Corrientes, Argentina, 3400
Córdoba, Argentina, 5000
Córdoba, Argentina, X5000AAX
Córdoba, Argentina, X5006IKK
Santa Fe, Argentina, 3000
Austria
Klagenfurt, Kärnten, Austria, 9020
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Feldkirch, Vorarlberg, Austria, 6807
Linz, Austria, 4021
Wien, Austria, 1090
Wien, Austria, 1140
Wien, Austria, 1160
Wien, Austria, 1170
Belgium
Bruxelles - Brussel, Belgium, 1070
Bruxelles - Brussel, Belgium, 1090
Bruxelles - Brussel, Belgium, 1200
Genk, Belgium, 3600
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Brazil
Fortaleza, Ceará, Brazil, 60430 370
Belo Horizonte, Minas Gerais, Brazil, 30110-090
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Belo Horizonte, Minas Gerais, Brazil, 30140-062
Belo Horizonte, Minas Gerais, Brazil, 30140-073
Uberlândia, Minas Gerais, Brazil, 38402-114
Curitiba, Parana, Brazil, 80010 030
Canoas, Rio Grande Do Sul, Brazil, 92425-900
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Porto Alegre, Rio Grande Do Sul, Brazil, 90619900
Porto Alegre, Rio Grande Do Sul, Brazil
Belo Horizonte, Sao Paulo, Brazil, 30110-130
Campinas, Sao Paulo, Brazil, 13060904
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, 01323-001
Tatui, Sao Paulo, Brazil, 18270-170
Rio de Janeiro, Brazil, 20551-030
Bulgaria
Burgas, Bulgaria, 8000
Panagyurishte, Bulgaria, 4500
Plovdiv, Bulgaria, 4002
Ruse, Bulgaria, 7002
Ruse, Bulgaria, 7013
Samokov, Bulgaria, 2000
Sofia, Bulgaria, 1309
Sofia, Bulgaria, 1407
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9010
Yambol, Bulgaria, 8600
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1C 2H6
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
London, Ontario, Canada, ON N6A 5W9
Ottawa, Ontario, Canada, K1Y 4E9
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Gatineau, Quebec, Canada, J8Y 6S8
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H3T 1E2
St. Jerome, Quebec, Canada, J7Z 5T3
Canada
Montreal, Quebec, Canada, H4A 3J1
Quebec, Canada, G1L 3L5
Vancouver, Canada, V5Z 1M9
China, Anhui
Hefei, Anhui, China, 230001
China, Chongqing
Chongqing, Chongqing, China
China, Fujian
Fuzhou, Fujian, China, 350025
Zhangzhou, Fujian, China, 363000
China, Guangdong
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China, 510630
Guangzhou, Guangdong, China
Zhanjiang, Guangdong, China, 524001
Zhongshan, Guangdong, China, 528403
China, Hainan
Haikou, Hainan, China, 570311
China, Hubei
Wuhan, Hubei, China, 430014
Wuhan, Hubei, China, 430030
China, Hunan
Changsha, Hunan, China, 410008
Changsha, Hunan, China, 410011
China, Jiangsu
Changzhou, Jiangsu, China, 213003
Nanjing, Jiangsu, China, 210006
China, Jilin
Changchun, Jilin, China, 130021
China, Shaanxi
Xi'an, Shaanxi, China, 710038
China, Shandong
Qingdao, Shandong, China, 266003
China, Shanxi
Taiyuan, Shanxi, China, 030001
China, Zhejiang
Taizhou, Zhejiang, China, 317000
Wenzhou, Zhejiang, China, 325000
China
Beijing, China, 100029
Beijing, China, 100053
Beijing, China, 100083
Beijing, China, 100144
Beijing, China, 100730
Beijing, China, 100853
Shanghai, China, 200032
Shanghai, China, 200040
Tianjin, China, 300000
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, 796 01
Vratimov, Czechia, 73932
Denmark
Aarhus N, Denmark, 8200
Kolding, Denmark, 6000
København Ø, Denmark, 2100
Odense C, Denmark, 5000
Viborg, Denmark, 8800
Estonia
Tallinn, Estonia, 13419
Tallin, Estonia, 11312
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
Paris Cedex 15, France, 75908
Paris, France, 75634
POITIERS cedex, France, 86021
Rennes Cedex, France, 35033
Strasbourg, France, 67091
Toulouse, France, 31300
Toulouse, France, 31403
Germany
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, 89075
Erlangen, Bayern, Germany, 91054
Immenstadt, Bayern, Germany, 87509
München, Bayern, Germany, 80331
München, Bayern, Germany, 80336
München, Bayern, Germany, 81675
Regensburg, Bayern, Germany, 93053
Rosenheim, Bayern, Germany, 83022
Bad Nauheim, Hessen, Germany, 61231
Darmstadt, Hessen, Germany, 64276
Frankfurt, Hessen, Germany, 60389
Frankfurt, Hessen, Germany, 60596
Frankfurt, Hessen, Germany, 65929
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
Kaiserslautern, Rheinland-Pfalz, Germany, 67657
Mainz, Rheinland-Pfalz, Germany, 55131
Magdeburg, Sachsen-Anhalt, Germany, 39120
Dresden, Sachsen, Germany, 01099
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04103
Lübeck, Schleswig-Holstein, Germany, 23538
Jena, Thüringen, Germany, 07740
Sonneberg, Thüringen, Germany, 96515
Berlin, Germany, 10713
Berlin, Germany, 10787
Bremen, Germany, 28277
Dresden, Germany, 01067
Hamburg, Germany, 20246
Hungary
Budapest, Hungary, 1085
Budapest, Hungary, 1106
Budapest, Hungary, 1115
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
Potenza, Basilicata, Italy, 85100
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Ravenna, Emilia-Romagna, Italy, 48033
Reggio Emilia, Emilia-Romagna, Italy, 42100
Roma, Lazio, Italy, 00161
Milano, Lombardia, Italy, 20132
Varese, Lombardia, Italy, 21100
Macerata, Marche, Italy, 62100
Torino, Piemonte, Italy, 10126
Lecce, Puglia, Italy, 73100
Palermo, Sicilia, Italy, 90127
Ragusa, Sicilia, Italy, 97100
Firenze, Toscana, Italy, 50134
Perugia, Umbria, Italy, 06156
Japan
Nagakute, Aichi, Japan, 480-1195
Matsuyama, Ehime, Japan, 790-8524
Kitakyushu, Fukuoka, Japan, 802-8555
Kitakyushu, Fukuoka, Japan, 805-0050
Kurume, Fukuoka, Japan, 830-8577
Shibukawa, Gunma, Japan, 377-0061
Hatsukaichi, Hiroshima, Japan, 738-8503
Asahikwa, Hokkaido, Japan, 078-8510
Sapporo, Hokkaido, Japan, 060-0031
Sapporo, Hokkaido, Japan, 064-8622
Tomakomai, Hokkaido, Japan, 053-8506
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
Morioka, Iwate, Japan, 020-0066
Takamatsu, Kagawa, Japan, 760-8557
Kawasaki, Kanagawa, Japan, 215-0026
Sagamihara, Kanagawa, Japan, 252-5188
Matsusaka, Mie, Japan, 515-8566
Matsumoto, Nagano, Japan, 390-8621
Kashihara, Nara, Japan, 634-8522
Beppu, Oita, Japan, 874-0011
Habikino, Osaka, Japan, 583-0872
Kawagoe, Saitama, Japan, 350-8550
Omihachiman, Shiga, Japan, 523-0082
Hamada, Shimane, Japan, 697-8511
Bunkyo-ku, Tokyo, Japan, 113-8519
Fuchu, Tokyo, Japan, 183-0003
Itabashi-ku, Tokyo, Japan, 173-0015
Itabashi-ku, Tokyo, Japan, 173-8610
Meguro-ku, Tokyo, Japan, 152-8902
Minato-ku, Tokyo, Japan, 108-8329
Minato, Tokyo, Japan, 108-0073
Suginami-ku, Tokyo, Japan, 166-0001
Gifu, Japan, 500-8717
Kagoshima, Japan, 890-8760
Kumamoto, Japan, 860-0008
Kyoto, Japan, 604-8401
Kyoto, Japan, 615-8256
Miyazaki, Japan, 880-0834
Osaka, Japan, 530-0012
Osaka, Japan, 530-8480
Osaka, Japan, 558-8558
Saitama, Japan, 336-8522
Shizuoka, Japan, 420-8630
Korea, Republic of
Goyang-si, Gyeonggido, Korea, Republic of, 410-773
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Incheon, Incheon Gwang''yeogsi, Korea, Republic of, 405-760
Busan, Korea, Republic of, 49201
Daegu, Korea, Republic of, 700-712
Daegu, Korea, Republic of, 705-718
Daejeon, Korea, Republic of, 301-723
Jung-gu Daejeon, Korea, Republic of, 301-721
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 134-791
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of
Latvia
Daugavpils, Latvia, LV-5417
Liepaja, Latvia, LV-3414
Riga, Latvia, 1038
Riga, Latvia, LV-1002
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, 01-211
Warszawa, Poland, 01-868
Warszawa, Poland, 02-097
Wroclaw, Poland, 50-981
Portugal
Almada, Portugal, 2805-267
Lisboa, Portugal, 1169-1024
Ponta Delgada, Portugal, 9500-370
Porto, Portugal, 4099-001
Porto, Portugal, 4200-319
Vila Nova de Gaia, Portugal, 4434-502
Romania
Pitesti, Arges, Romania, 110084
Bucharest, Romania, 010192
Bucharest, Romania, 011461
Bucharest, Romania, 022322
Cluj Napoca, Romania, 400001
Iasi, Romania, 700732
Oradea, Romania
Targu Mures, Romania, 540124
Timisoara, Romania, 300736
Russian Federation
Kemerovo, Russian Federation, 650002
Moscow, Russian Federation, 105077
Moscow, Russian Federation, 115682
Moscow, Russian Federation, 117997
Moscow, Russian Federation, 129327
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, 191015
St. Petersburg, Russian Federation, 194291
St. Petersburg, Russian Federation, 194354
St. Petersburg, Russian Federation, 195271
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 37, Slovakia, 833 48
Bratislava, Slovakia, 83348
Bratislava, Slovakia, 85107
Dunajska Streda, Slovakia, 92901
Kosice, Slovakia, 04001
Nitra, Slovakia, 949 01
Nove Zamky, Slovakia, 940 01
Trnava, Slovakia, 91701
Zilina, Slovakia, 01001
Spain
Cádiz, Andalucía, Spain, 11009
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sabadell, Barcelona, Spain, 08208
A Coruña, Spain, 15006
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Ciudad Real, Spain, 13005
Granada, Spain, 18012
Madrid, Spain, 28006
Pamplona, Spain, 31008
Tarragona, Spain, 43007
Sweden
Göteborg, Sweden, 413 46
Linköping, Sweden, 582 85
Malmö, Sweden, 205 02
Solna, Sweden, 171 76
Växjö, Sweden, 351 85
Switzerland
Basel, Basel-Stadt, Switzerland, 4031
Chur, Graubünden, Switzerland, 7000
St. Gallen, Sankt Gallen, Switzerland, 9007
Baden, Switzerland, 5404
Bern, Switzerland, 3010
Fribourg, Switzerland, 1700
Genève, Switzerland, 1205
Luzern, Switzerland, 6000
Taiwan
Hsinchu City, Taiwan, 30071
Kaohsiung, Taiwan, 813
Kaohsiung, Taiwan, 82445
Tainan, Taiwan, 70428
Taipei, Taiwan, 10002
Taipei, Taiwan, 11217
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Bangkok, Thailand
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
Carlisle, Cumbria, United Kingdom, CA2 7HY
Hull, Humberside, United Kingdom, HU3 2JZ
Harrow, London, United Kingdom, HA1 3UJ
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Birmingham, West Midlands, United Kingdom, B9 5SS
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Worcester, Worcestershire, United Kingdom, WR5 1DD
Cambridge, United Kingdom, CB3 OLB
Cheltenham, United Kingdom, GL53 7AN
London, United Kingdom, NW3 2QG
London, United Kingdom, SW17 0QT
London, United Kingdom, W6 8RF
Manchester, United Kingdom, M13 9WL
Manchester, United Kingdom, M23 9LT
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Colorado Prevention Center
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02504216     History of Changes
Other Study ID Numbers: 17454
2014-005569-58 ( EudraCT Number )
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Rivaroxaban
Xarelto
Aspirin
Acetylic salicylic acid
Anticoagulant
Peripheral artery disease
Peripheral arterial disease
Revascularization
Acute limb ischemia
Amputation
Cardiovascular events
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants