AzTrials
AzTrials

Peripheral Artery DiseasePhase 3VOYAGER PADNCT02504216

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

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Peripheral Artery Disease, run by Bayer at 532 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,564 participants
Where
532 sitesin 34 countries
Study dates
18 Aug 2015to 9 Jan 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

532 sites in 34 countries.

532 sites in 34 countries

United States105 sites

  • Study site

    Alexander City, Alabama, 35010

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Arlington Heights, Illinois, 60005

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78705

  • Study site

    Avondale, Arizona, 85388

  • Study site

    Baltimore, Maryland, 21201-1595

  • Study site

    Baltimore, Maryland, 21218

  • Study site

    Bay City, Michigan, 48708

  • Study site

    Birmingham, Alabama, 35294-0012

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Chapel Hill, North Carolina, 27517

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Clinton, Maryland, 20735

  • Study site

    Coon Rapids, Minnesota, 55433

  • Study site

    Covington, Louisiana, 70433

  • Study site

    Dallas, Texas, 75216-7167

  • Study site

    Dallas, Texas, 75226

  • Study site

    Dayton, Ohio, 45414

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Dearborn, Michigan, 48126

  • Study site

    Denver, Colorado, 80220

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Edinburg, Texas, 78539

  • Study site

    Elk Grove Village, Illinois, 60007

  • Study site

    Erie, Pennsylvania, 16507

  • Study site

    Flemington, New Jersey, 08822

  • Study site

    Fort Payne, Alabama, 35967

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Fort Wayne, Indiana, 46845

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Glendale, Arizona, 85340

  • Study site

    Greenville, South Carolina, 29657

  • Study site

    Hillsboro, Oregon, 97123

  • Study site

    Houston, Texas, 77030

  • Study site

    Hudson, Florida, 34667

  • Study site

    Humble, Texas, 77338

  • Study site

    Huntsville, Alabama, 35801-4317

  • Study site

    Huntsville, Texas, 77340

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kingwood, Texas, 77339

  • Study site

    Knoxville, Tennessee, 37934

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Lebanon, New Hampshire, 03756-0001

  • Study site

    Lewiston, Maine, 04240

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Linden, New Jersey, 07036

  • Study site

    Madison, Wisconsin, 53713

  • Study site

    Manitowoc, Wisconsin, 54220

  • Study site

    Merrillville, Indiana, 46410

  • Study site

    Miami, Florida, 33173

  • Study site

    Midland, Michigan, 48670

  • Study site

    Minot, North Dakota, 58701

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Muskegon, Michigan, 49444

  • Study site

    New York, New York, 10011

  • Study site

    New York, New York, 10029

  • Study site

    Northridge, California, 91325

  • Study site

    Ocala, Florida, 34474

  • Study site

    Oklahoma City, Oklahoma, 73135

  • Study site

    Palo Alto, California, 94304

  • Study site

    Pensacola, Florida, 32501

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Roseville, California, 95661

  • Study site

    Safety Harbor, Florida, 34695

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    San Antonio, Texas, 78258

  • Study site

    Saratoga Springs, New York, 12866

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Shreveport, Louisiana, 71105

  • Study site

    Springfield, Illinois, 62701

  • Study site

    Springfield, Illinois, 62702

  • Study site

    Springfield, Missouri, 65807

  • Study site

    Springfield, Ohio, 45505

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Stanford, California, 94305

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Torrance, California, 90502

  • Study site

    Tupelo, Mississippi, 38801

  • Study site

    Tyler, Texas, 75701

  • Study site

    Urbana, Illinois, 61801

  • Study site

    Victoria, Texas, 77901

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Washington D.C., District of Columbia, 20422

  • Study site

    Wausau, Wisconsin, 54401

  • Study site

    Wellington, Florida, 33449

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyoming, Michigan, 49519

  • Study site

    York, Pennsylvania, 17405

Other trials in United States

Japan48 sites

  • Study site

    Amagasaki, Hyōgo, 660-8511

  • Study site

    Asahikwa, Hokkaido, 078-8510

  • Study site

    Beppu, Oita Prefecture, 874-0011

  • Study site

    Bunkyo-ku, Tokyo, 113-8519

  • Study site

    Fuchū, Tokyo, 183-0003

  • Study site

    Gifu, 500-8717

  • Study site

    Habikino, Osaka, 583-0872

  • Study site

    Hamada, Shimane, 697-8511

  • Study site

    Hatsukaichi, Hiroshima, 738-8503

  • Study site

    Himeji, Hyōgo, 670-0981

  • Study site

    Himeji, Hyōgo, 671-1227

  • Study site

    Kagoshima, 890-8760

  • Study site

    Kashihara, Nara, 634-8522

  • Study site

    Kawagoe, Saitama, 350-8550

  • Study site

    Kawasaki, Kanagawa, 215-0026

  • Study site

    Kitakyushu, Fukuoka, 802-8555

  • Study site

    Kitakyushu, Fukuoka, 805-0050

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Kobe, Hyōgo, 651-0053

  • Study site

    Kumamoto, 860-0008

  • Study site

    Kurume, Fukuoka, 830-8577

  • Study site

    Kyoto, 604-8401

  • Study site

    Kyoto, 615-8256

  • Study site

    Matsumoto, Nagano, 390-8621

  • Study site

    Matsusaka, Mie-ken, 515-8566

  • Study site

    Matsuyama, Ehime, 790-8524

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Minato, Tokyo, 108-0073

  • Study site

    Minato-ku, Tokyo, 108-8329

  • Study site

    Miyazaki, 880-2102

  • Study site

    Morioka, Iwate, 020-0066

  • Study site

    Nagakute, Aichi-ken, 480-1195

  • Study site

    Ōmihachiman, Shiga, 523-0082

  • Study site

    Osaka, 530-0012

  • Study site

    Osaka, 530-8480

  • Study site

    Osaka, 558-8558

  • Study site

    Sagamihara, Kanagawa, 252-5188

  • Study site

    Saitama, 336-8522

  • Study site

    Sapporo, Hokkaido, 060-0031

  • Study site

    Sapporo, Hokkaido, 064-8622

  • Study site

    Shibukawa, Gunma, 377-0061

  • Study site

    Shizuoka, 420-8630

  • Study site

    Suginami-ku, Tokyo, 166-0001

  • Study site

    tabashi City, Tokyo, 173-0015

  • Study site

    tabashi City, Tokyo, 173-8610

  • Study site

    Takamatsu, Kagawa-ken, 760-8557

  • Study site

    Takarazuka, Hyōgo, 665-0873

  • Study site

    Tomakomai, Hokkaido, 053-8506

Other trials in Japan

Germany40 sites

  • Study site

    Arnsberg, North Rhine-Westphalia, 59759

  • Study site

    Bad Friedrichshall, Baden-Wurttemberg, 74177

  • Study site

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Study site

    Bad Nauheim, Hesse, 61231

  • Study site

    Berlin, 10713

  • Study site

    Berlin, 10787

  • Study site

    Bielefeld, North Rhine-Westphalia, 33604

  • Study site

    Bremen, 28277

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Study site

    Darmstadt, Hesse, 64276

  • Study site

    Dresden, Saxony, 01099

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Dresden, 01067

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Frankfurt am Main, Hesse, 65929

  • Study site

    Freudenstadt, Baden-Wurttemberg, 72250

  • Study site

    Hamburg, 20246

  • Study site

    Heidelberg, Baden-Wurttemberg, 69129

  • Study site

    Immenstadt im Allgäu, Bavaria, 87509

  • Study site

    Jena, Thuringia, 07740

  • Study site

    Kaiserslautern, Rhineland-Palatinate, 67657

  • Study site

    Karlsbad, Baden-Wurttemberg, 76307

  • Study site

    Karlsruhe, Baden-Wurttemberg, 76133

  • Study site

    Krefeld, North Rhine-Westphalia, 47805

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Lübeck, Schleswig-Holstein, 23538

  • Study site

    Magdeburg, Saxony-Anhalt, 39120

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 80331

  • Study site

    München, Bavaria, 80336

  • Study site

    München, Bavaria, 81675

  • Study site

    Münster, North Rhine-Westphalia, 48149

  • Study site

    Regensburg, Bavaria, 93053

  • Study site

    Rosenheim, Bavaria, 83022

  • Study site

    Sonneberg, Thuringia, 96515

  • Study site

    Ulm, Baden-Wurttemberg, 89081

  • Study site

    Wesel, North Rhine-Westphalia, 46483

Other trials in Germany

China31 sites

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100053

  • Study site

    Beijing, 100083

  • Study site

    Beijing, 100144

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 100853

  • Study site

    Changchun, Jilin, 130021

  • Study site

    Changsha, Hunan, 410008

  • Study site

    Changsha, Hunan, 410011

  • Study site

    Changzhou, Jiangsu, 213003

  • Study site

    Chongqing, Chongqing Municipality

  • Study site

    Fuzhou, Fujian, 350025

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou, Guangdong, 510630

  • Study site

    Guangzhou, Guangdong

  • Study site

    Haikou, Hainan, 570311

  • Study site

    Hefei, Anhui, 230001

  • Study site

    Nanjing, Jiangsu, 210006

  • Study site

    Qingdao, Shandong, 266003

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200040

  • Study site

    Taiyuan, Shanxi, 030001

  • Study site

    Taizhou, Zhejiang, 317000

  • Study site

    Tianjin, 300000

  • Study site

    Wenzhou, Zhejiang, 325000

  • Study site

    Wuhan, Hubei, 430014

  • Study site

    Wuhan, Hubei, 430030

  • Study site

    Xi'an, Shaanxi, 710038

  • Study site

    Zhangzhou, Fujian, 363000

  • Study site

    Zhanjiang, Guangdong, 524001

  • Study site

    Zhongshan, Guangdong, 528403

Other trials in China

Argentina23 sites

  • Study site

    Bahía Blanca, Buenos Aires, B8001HXM

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1078

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1119ACN

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1428ART

  • Study site

    Ciudad Auton. de Buenos Aires, C1181ACL

  • Study site

    Ciudadela, Buenos Aires, 1702

  • Study site

    Córdoba, 5000

  • Study site

    Córdoba, X5000AAX

  • Study site

    Córdoba, X5006IKK

  • Study site

    Coronel Suárez, Buenos Aires, B7540GHD

  • Study site

    Corrientes, 3400

  • Study site

    Junín, Buenos Aires, B6000BHA

  • Study site

    La Plata, Buenos Aires, 1900

  • Study site

    La Plata, Buenos Aires, B1900ASM

  • Study site

    Mar del Plata, Buenos Aires, 7600

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    Rosario, Santa Fe Province, S2000PBJ

  • Study site

    Rosario, Santa Fe Province, S2000QID

  • Study site

    San Isidro, Buenos Aires, B1642DCD

  • Study site

    San Martín, Buenos Aires, 1650

  • Study site

    Santa Fe, S3000FWO

  • Study site

    Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Brazil19 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30110-090

  • Study site

    Belo Horizonte, Minas Gerais, 30130-100

  • Study site

    Belo Horizonte, Minas Gerais, 30140-062

  • Study site

    Belo Horizonte, Minas Gerais, 30140-073

  • Study site

    Belo Horizonte, São Paulo, 30110-130

  • Study site

    Campinas, São Paulo, 13060-080

  • Study site

    Canoas, Rio Grande do Sul, 92200-000

  • Study site

    Curitiba, Paraná, 80230-130

  • Study site

    Fortaleza, Ceará, 60430 370

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Study site

    Porto Alegre, Rio Grande do Sul, 90619900

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Rio de Janeiro, 20551-030

  • Study site

    Santo André, São Paulo, 09030-010

  • Study site

    São Bernardo do Campo, São Paulo, 09715-090

  • Study site

    São José do Rio Preto, São Paulo, 15090

  • Study site

    São Paulo, São Paulo, 01323-903

  • Study site

    Tatuí, São Paulo, 18270-170

  • Study site

    Uberlândia, Minas Gerais, 38411-186

Other trials in Brazil

Russia18 sites

  • Study site

    Kemerovo, 650002

  • Study site

    Moscow, 105077

  • Study site

    Moscow, 115682

  • Study site

    Moscow, 117997

  • Study site

    Moscow, 129327

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Novosibirsk, 630055

  • Study site

    Novosibirsk, 630087

  • Study site

    Rostov-on-Don, 344022

  • Study site

    Ryazan, 390026

  • Study site

    Saint Petersburg, 191015

  • Study site

    Saint Petersburg, 194291

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195271

  • Study site

    Saint Petersburg, 197374

  • Study site

    Tomsk, 634012

  • Study site

    Tver', 170036

  • Study site

    Voronezh, 394066

Other trials in Russia

France16 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Bordeaux, 33075

  • Study site

    Caen, 14033

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Grenoble, 38043

  • Study site

    Le Coudray, 28630

  • Study site

    Limoges, 87042

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06280

  • Study site

    Paris, 75634

  • Study site

    Paris, 75908

  • Study site

    Poitiers, 86021

  • Study site

    Rennes, 35033

  • Study site

    Strasbourg, 67091

  • Study site

    Toulouse, 31300

  • Study site

    Toulouse, 31403

Other trials in France

Italy16 sites

  • Study site

    Avellino, Campania, 83100

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Florence, Tuscany, 50134

  • Study site

    Lecce, Apulia, 73100

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Naples, Campania, 80131

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Perugia, Umbria, 06132

  • Study site

    Potenza, Basilicate, 85100

  • Study site

    Province of Macerata, The Marches, 62100

  • Study site

    Ragusa, Sicily, 97100

  • Study site

    Ravenna, Emilia-Romagna, 48033

  • Study site

    Reggio Emilia, Emilia-Romagna, 42100

  • Study site

    Rome, Lazio, 00161

  • Study site

    Turin, Piedmont, 10126

  • Study site

    Varese, Lombardy, 21100

Other trials in Italy

United Kingdom16 sites

  • Study site

    Birmingham, West Midlands, B9 5SS

  • Study site

    Cambridge, CB3 OLB

  • Study site

    Carlisle, Cumbria, CA2 7HY

  • Study site

    Cheltenham, GL53 7AN

  • Study site

    Doncaster, South Yorkshire, DN2 5LT

  • Study site

    Harrow, London, HA1 3UJ

  • Study site

    Hull, Humberside, HU3 2JZ

  • Study site

    Leeds, West Yorkshire, LS1 3EX

  • Study site

    London, NW3 2QG

  • Study site

    London, SW17 0QT

  • Study site

    London, W6 8RF

  • Study site

    Manchester, M13 9WL

  • Study site

    Manchester, M23 9LT

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Study site

    Sheffield, S5 7AU

  • Study site

    Worcester, Worcestershire, WR5 1DD

Other trials in United Kingdom

Canada15 sites

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Gatineau, Quebec, J8Y 6S8

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    London, Ontario, ON N6A 5W9

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Montreal, Quebec, H4A 3J1

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Québec, G1L 3L5

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    St. John's, Newfoundland and Labrador, A1C 2H6

  • Study site

    Vancouver, V5Z 1M9

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Poland14 sites

  • Study site

    Bialystok, 15_111

  • Study site

    Bydgoszcz, 85-094

  • Study site

    Gdynia, 81-338

  • Study site

    Katowice, 40-040

  • Study site

    Krakow

  • Study site

    Lodz, 94-048

  • Study site

    Lublin, 20-044

  • Study site

    Lublin, 20-718

  • Study site

    Poznan, 61-848

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 01-211

  • Study site

    Warsaw, 01-868

  • Study site

    Warsaw, 02-097

  • Study site

    Wroclaw, 50-981

Other trials in Poland

South Korea14 sites

  • Study site

    Busan, 49201

  • Study site

    Daegu, 42472

  • Study site

    Daegu, 700-712

  • Study site

    Daejeon, 301-723

  • Study site

    Goyang-si, Gyeonggido, 10326

  • Study site

    Incheon, Incheon Gwang''yeogsi, 21565

  • Study site

    Jung-gu Daejeon, 35015

  • Study site

    Seongnam-si, Gyeonggido, 13620

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 05368

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 152-703

  • Study site

    Seoul

Other trials in South Korea

Bulgaria13 sites

  • Study site

    Burgas, 8000

  • Study site

    Panagyurishte, 4500

  • Study site

    Plovdiv, 4002

  • Study site

    Rousse, 7002

  • Study site

    Rousse, 7013

  • Study site

    Samokov, 2000

  • Study site

    Sofia, 1309

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1606

  • Study site

    Stara Zagora, 6000

  • Study site

    Varna, 9010

  • Study site

    Yambol, 8600

Other trials in Bulgaria

Czechia13 sites

  • Study site

    Brno, 656 91

  • Study site

    Hodonín, 69501

  • Study site

    Hradec Králové, 500 05

  • Study site

    Kladno, 27259

  • Study site

    Liberec, 460 63

  • Study site

    Olomouc, 775 20

  • Study site

    Pilsen, 30599

  • Study site

    Prague, 10100

  • Study site

    Prague, 12808

  • Study site

    Prague, 150 06

  • Study site

    Prague, 15006

  • Study site

    Prostějov, 798 11

  • Study site

    Vratimov, 73932

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Hungary13 sites

  • Study site

    Budapest, 1085

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1115

  • Study site

    Debrecen, 4032

  • Study site

    Győr, 9023

  • Study site

    Kaposvár, 7400

  • Study site

    Kistarcsa, 2143

  • Study site

    Miskolc, 3526

  • Study site

    Nyíregyháza, 4400

  • Study site

    Pécs, 7624

  • Study site

    Szeged, 6725

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szombathely, 9700

Other trials in Hungary

Spain11 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Cadiz, Andalusia, 11009

  • Study site

    Ciudad Real, 13005

  • Study site

    Granada, 18012

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28006

  • Study site

    Pamplona, 31008

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Tarragona, 43005

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Slovakia10 sites

  • Study site

    Bardejov, 085 01

  • Study site

    Bratislava, 833 48

  • Study site

    Bratislava, 83348

  • Study site

    Bratislava, 851 07

  • Study site

    Dunajská Streda, 92901

  • Study site

    Košice, 04001

  • Study site

    Nitra, 949 01

  • Study site

    Nové Zámky, 940 01

  • Study site

    Trnava, 91701

  • Study site

    Žilina, 01001

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Austria9 sites

  • Study site

    Feldkirch, Vorarlberg, 6807

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, Tyrol, 6020

  • Study site

    Klagenfurt, Carinthia, 9020

  • Study site

    Linz, 4021

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1140

  • Study site

    Vienna, 1160

  • Study site

    Vienna, 1170

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Romania9 sites

  • Study site

    Bucharest, 010192

  • Study site

    Bucharest, 011461

  • Study site

    Bucharest, 022322

  • Study site

    Cluj-Napoca, 400001

  • Study site

    Iași, 700732

  • Study site

    Oradea

  • Study site

    Piteşti, Argeş, 110084

  • Study site

    Târgu Mureş, 540124

  • Study site

    Timișoara, 300736

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Ukraine9 sites

  • Study site

    Dnipro, 49000

  • Study site

    Ivano-Frankivsk, 76000

  • Study site

    Ivano-Frankivsk, 76014

  • Study site

    Kharkiv, 61018

  • Study site

    Kiev, 3680

  • Study site

    Kyiv, 1601

  • Study site

    Lviv, 79010

  • Study site

    Vinnytsia, 21018

  • Study site

    Zaporizhzhya, 69600

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Switzerland8 sites

  • Study site

    Baden, 5404

  • Study site

    Basel, Canton of Basel-City, 4031

  • Study site

    Bern, 3010

  • Study site

    Chur, Kanton Graubünden, 7000

  • Study site

    Fribourg, 1700

  • Study site

    Geneva, 1205

  • Study site

    Lucerne, 6000

  • Study site

    Sankt Gallen, Canton of St. Gallen, 9007

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Belgium7 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Genk, 3600

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

  • Study site

    Leuven, 3000

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Netherlands7 sites

  • Study site

    's-Hertogenbosch, 5223 GZ

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Enschede, 7611 JH

  • Study site

    Heerlen, 6419 PC

  • Study site

    Utrecht, 3584 CX

  • Study site

    Veldhoven, 5504 DB

  • Study site

    Zwolle, 8025 AB

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Taiwan7 sites

  • Study site

    Hsinchu, 300

  • Study site

    Kaohsiung City, 813

  • Study site

    Kaohsiung City, 82445

  • Study site

    Tainan, 704

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 11217

  • Study site

    Taoyuan, 333423

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Portugal6 sites

  • Study site

    Almada, Setúbal District, 2805-267

  • Study site

    Lisbon, 1169-1024

  • Study site

    Ponta Delgada, 9500-370

  • Study site

    Porto, 4099-001

  • Study site

    Porto, 4200-319

  • Study site

    Vila Nova de Gaia, 4434-502

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Thailand6 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Bangkok

  • Study site

    Khon Kaen, 40002

  • Study site

    Songkhla, 90110

Other trials in Thailand

Denmark5 sites

  • Study site

    Aarhus N, 8200

  • Study site

    København Ø, 2100

  • Study site

    Kolding, 6000

  • Study site

    Odense C, 5000

  • Study site

    Viborg, 8800

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Lithuania5 sites

  • Study site

    Kaunas, 45130

  • Study site

    Kaunas, LT-50009

  • Study site

    Panevezys, 35144

  • Study site

    Vilnius, LT-08661

  • Study site

    Vilnius, LT-10207

Other trials in Lithuania

Sweden5 sites

  • Study site

    Gothenburg, 413 46

  • Study site

    Linköping, 582 85

  • Study site

    Malmö, 205 02

  • Study site

    Solna, 171 76

  • Study site

    Vaxjo, 351 85

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Latvia4 sites

  • Study site

    Daugavpils, LV-5417

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    Liepāja, LV-3414

  • Study site

    Riga, 1038

  • Study site

    Riga, LV-1002

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Serbia4 sites

  • Study site

    Belgrade, 11000

  • Study site

    Belgrade, 11040

  • Study site

    Belgrade, 11080

  • Study site

    Niš, 18000

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Estonia3 sites

  • Study site

    Tallinn, 11312

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 50406

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Finland3 sites

  • Study site

    Helsinki, 00290

  • Study site

    Oulu, 90220

  • Study site

    Tampere, 33521

Other trials in Finland

About this study

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

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban-Placebo
Keywords
Rivaroxaban, Xarelto, Aspirin, Acetylic salicylic acid, Anticoagulant, Peripheral artery disease, Peripheral arterial disease, Revascularization, Acute limb ischemia, Amputation, Cardiovascular events
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    2.5 mg, twice daily, orally, tablet

  • Rivaroxaban-PlaceboDrug

    matching placebo, twice daily, orally, tablet

Study groups in NCT02504216
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
PlaceboPlacebo comparatorRivaroxaban-placebo orally twice daily
Receives: Drug: Rivaroxaban-Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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 outcomes (9)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. Number of Mortality (All-cause)

    Measured: 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

  7. Number of Participants With Venous Thromboembolic (VTE) Events

    Venous thromboembolic events were reported by investigator only.

    Measured: 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

  8. 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.

    Measured: 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).

  9. 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2015 (estimated)
  2. Study start18 Aug 2015
  3. Primary completion27 Nov 2019
  4. Study completion9 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02504216
Sponsor's protocol ID
17454
Other IDs
2014-005569-58, 2014
Acronym
VOYAGER PAD
Status last verified
Dec 2020
First submitted
20 Jul 2015
Last updated
8 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Canonico ME, Parr J, Debus ES, Nehler MR, Patel MR, Anand SS, Svet M, Hess CN, Capell WH, Ycas J, Chen J, Szarek M, Muehlhofer E, Haskell LP, Berkowitz SD, Bauersachs RM, Bonaca MP. Low-Dose Rivaroxaban Plus Aspirin in Patients With PAD Undergoing Lower Extremity Revascularization With and Without History of Prior Limb Revascularization: Insight From the VOYAGER-PAD Trial. Circ Cardiovasc Interv. 2026 May;19(5):e015229. doi: 10.1161/CIRCINTERVENTIONS.125.015229. Epub 2026 Feb 27.

    PubMed 41757414

  • Hogan S, Szarek M, Debus ES, Nehler M, Anand SS, Patel MR, Pap AF, Deng H, Hodge S, Haskell LP, Muehlhofer E, Berkowitz SE, Bauersachs RM, Bonaca MP. Rivaroxaban in Peripheral Artery Disease After Revascularization: Worst Events and Net Outcomes in VOYAGER PAD. J Am Heart Assoc. 2025 Nov 4;14(21):e039752. doi: 10.1161/JAHA.124.039752. Epub 2025 Oct 23.

    PubMed 41128134

  • Rogers RK, Herold J, Govsyeyev N, Iezzi R, Morrison J, Hogan SE, Nehler M, Bricker R, Andring B, Bergmark B, Cavender M, Malgor E, Jacobs D, Young MN, Capell W, Ycas JW, Anand SS, Berkowitz SD, Debus ES, Haskell LP, Muehlhofer E, Patel MR, Hess CN, Bauersachs RM, Anderson V, Bonaca MP. Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD. Vasc Med. 2024 Apr;29(2):143-152. doi: 10.1177/1358863X241228542. Epub 2024 Mar 17.

    PubMed 38493348

  • Hogan SE, Debus ES, Nehler MR, Patel MR, Anand SS, Muehlhofer E, Haskell LP, Berkowitz SD, Bauersachs RM, Bonaca MP. Unplanned Index Limb Revascularization With Rivaroxaban Versus Placebo in Patients With Critical Limb-Threatening Ischemia After Endovascular and Surgical Treatment: Insights From VOYAGER PAD. Circulation. 2024 Feb 20;149(8):635-637. doi: 10.1161/CIRCULATIONAHA.123.065330. Epub 2024 Feb 20. No abstract available.

    PubMed 38377256

  • Govsyeyev N, Nehler M, Conte MS, Debus S, Chung J, Dorigo W, Gudz I, Krievins D, Mills J, Moll F, Norgren L, Piffaretti G, Powell R, Szalay D, Sillesen H, Wohlauer M, Szarek M, Bauersachs RM, Anand SS, Patel MR, Capell WH, Jaeger N, Hess CN, Muehlhofer E, Haskell LP, Berkowitz SD, Bonaca MP. Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits. J Vasc Surg. 2023 Apr;77(4):1107-1118.e2. doi: 10.1016/j.jvs.2022.11.062. Epub 2022 Dec 5.

    PubMed 36470531

  • 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.

    PubMed 35699170

  • 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.

    PubMed 35467452

  • 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.

    PubMed 34711335

  • 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.

    PubMed 34380322

  • 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.

    PubMed 34010631

  • 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.

    PubMed 33138628

  • 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.

    PubMed 32222135

  • 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.

    PubMed 29754671

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Peripheral Artery Disease, run by Bayer at 532 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 532 sites in United States, Japan, Germany, China, Argentina and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02504216, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.

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