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
NCT ID: NCT02504216
Last Updated: 2020-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6564 participants
INTERVENTIONAL
2015-08-18
2020-01-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rivaroxaban
Rivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)
Rivaroxaban (Xarelto, BAY59-7939)
2.5 mg, twice daily, orally, tablet
Placebo
Rivaroxaban-placebo orally twice daily
Rivaroxaban-Placebo
matching placebo, twice daily, orally, tablet
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
2.5 mg, twice daily, orally, tablet
Rivaroxaban-Placebo
matching placebo, twice daily, orally, tablet
Eligibility Criteria
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Inclusion Criteria
* 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 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.
50 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Colorado Prevention Center
OTHER
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Alexander City, Alabama, United States
Birmingham, Alabama, United States
Fort Payne, Alabama, United States
Huntsville, Alabama, United States
Avondale, Arizona, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Mission Viejo, California, United States
Northridge, California, United States
Palo Alto, California, United States
Roseville, California, United States
Stanford, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Atlantis, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Gainesville, Florida, United States
Hudson, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Pensacola, Florida, United States
Safety Harbor, Florida, United States
Tallahassee, Florida, United States
Wellington, Florida, United States
Arlington Heights, Illinois, United States
Elk Grove Village, Illinois, United States
Springfield, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Fort Wayne, Indiana, United States
Fort Wayne, Indiana, United States
Merrillville, Indiana, United States
Iowa City, Iowa, United States
Lexington, Kentucky, United States
Alexandria, Louisiana, United States
Covington, Louisiana, United States
Shreveport, Louisiana, United States
Shreveport, Louisiana, United States
Lewiston, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Clinton, Maryland, United States
Bay City, Michigan, United States
Dearborn, Michigan, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
Midland, Michigan, United States
Muskegon, Michigan, United States
Wyoming, Michigan, United States
Coon Rapids, Minnesota, United States
Saint Cloud, Minnesota, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Lincoln, Nebraska, United States
Lebanon, New Hampshire, United States
Flemington, New Jersey, United States
Linden, New Jersey, United States
Teaneck, New Jersey, United States
New York, New York, United States
New York, New York, United States
Saratoga Springs, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Minot, North Dakota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Springfield, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Hillsboro, Oregon, United States
Camp Hill, Pennsylvania, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
York, Pennsylvania, United States
Greenville, South Carolina, United States
Rapid City, South Dakota, United States
Knoxville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Huntsville, Texas, United States
Kingwood, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Victoria, Texas, United States
Madison, Wisconsin, United States
Manitowoc, Wisconsin, United States
Wausau, Wisconsin, United States
Bahía Blanca, Buenos Aires, Argentina
Ciudadela, Buenos Aires, Argentina
Coronel Suárez, Buenos Aires, Argentina
Junín, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
San Isidro, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Santa Rosa, La Pampa Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Ciudad Auton. de Buenos Aires, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Klagenfurt, Carinthia, Austria
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Feldkirch, Vorarlberg, Austria
Linz, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Genk, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Fortaleza, Ceará, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Uberlândia, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Canoas, Rio Grande do Sul, Brazil
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Belo Horizonte, São Paulo, Brazil
Campinas, São Paulo, Brazil
Santo André, São Paulo, Brazil
São Bernardo do Campo, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Tatuí, São Paulo, Brazil
Rio de Janeiro, , Brazil
Burgas, , Bulgaria
Panagyurishte, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Rousse, , Bulgaria
Samokov, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Yambol, , Bulgaria
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Chicoutimi, Quebec, Canada
Gatineau, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Montreal, Quebec, , Canada
Québec, , Canada
Vancouver, , Canada
Hefei, Anhui, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Zhangzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Zhanjiang, Guangdong, China
Zhongshan, Guangdong, China
Haikou, Hainan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Changzhou, Jiangsu, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Xi'an, Shaanxi, China
Qingdao, Shandong, China
Taiyuan, Shanxi, China
Taizhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Brno, , Czechia
Hodonín, , Czechia
Hradec Králové, , Czechia
Kladno, , Czechia
Liberec, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prostějov, , Czechia
Vratimov, , Czechia
Aarhus N, , Denmark
Kolding, , Denmark
København Ø, , Denmark
Odense C, , Denmark
Viborg, , Denmark
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Helsinki, , Finland
Oulu, , Finland
Tampere, , Finland
Bordeaux, , France
Bordeaux, , France
Caen, , France
Castelnau-le-Lez, , France
Grenoble, , France
Le Coudray, , France
Limoges, , France
Montpellier, , France
Nice, , France
Paris, , France
Paris, , France
Poitiers, , France
Rennes, , France
Strasbourg, , France
Toulouse, , France
Toulouse, , France
Bad Friedrichshall, Baden-Wurttemberg, Germany
Bad Krozingen, Baden-Wurttemberg, Germany
Freudenstadt, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Karlsbad, Baden-Wurttemberg, Germany
Karlsruhe, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
Immenstadt im Allgäu, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Rosenheim, Bavaria, Germany
Bad Nauheim, Hesse, Germany
Darmstadt, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Arnsberg, North Rhine-Westphalia, Germany
Bielefeld, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Krefeld, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Wesel, North Rhine-Westphalia, Germany
Kaiserslautern, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Lübeck, Schleswig-Holstein, Germany
Jena, Thuringia, Germany
Sonneberg, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Bremen, , Germany
Dresden, , Germany
Hamburg, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Kaposvár, , Hungary
Kistarcsa, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Szombathely, , Hungary
Lecce, Apulia, Italy
Potenza, Basilicate, Italy
Avellino, Campania, Italy
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Ravenna, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Varese, Lombardy, Italy
Turin, Piedmont, Italy
Palermo, Sicily, Italy
Ragusa, Sicily, Italy
Macerata, The Marches, Italy
Florence, Tuscany, Italy
Perugia, Umbria, Italy
Nagakute, Aichi-ken, Japan
Matsuyama, Ehime, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Shibukawa, Gunma, Japan
Hatsukaichi, Hiroshima, Japan
Asahikwa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomai, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Himeji, Hyōgo, Japan
Himeji, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kobe, Hyōgo, Japan
Takarazuka, Hyōgo, Japan
Morioka, Iwate, Japan
Takamatsu, Kagawa-ken, Japan
Kawasaki, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Matsusaka, Mie-ken, Japan
Matsumoto, Nagano, Japan
Kashihara, Nara, Japan
Beppu, Oita Prefecture, Japan
Habikino, Osaka, Japan
Kawagoe, Saitama, Japan
Ōmihachiman, Shiga, Japan
Hamada, Shimane, Japan
Bunkyo-ku, Tokyo, Japan
Fuchū, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato, Tokyo, Japan
Minato-ku, Tokyo, Japan
Suginami-ku, Tokyo, Japan
Gifu, , Japan
Kagoshima, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Kyoto, , Japan
Miyazaki, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Saitama, , Japan
Shizuoka, , Japan
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Panevezys, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
's-Hertogenbosch, , Netherlands
Eindhoven, , Netherlands
Enschede, , Netherlands
Heerlen, , Netherlands
Utrecht, , Netherlands
Veldhoven, , Netherlands
Zwolle, , Netherlands
Bialystok, , Poland
Bydgoszcz, , Poland
Gdynia, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Almada, Setúbal District, Portugal
Lisbon, , Portugal
Ponta Delgada, , Portugal
Porto, , Portugal
Porto, , Portugal
Vila Nova de Gaia, , Portugal
Piteşti, Argeş, Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Oradea, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Rostov-on-Don, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Tver', , Russia
Voronezh, , Russia
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Niš, , Serbia
Bardejov, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Dunajská Streda, , Slovakia
Košice, , Slovakia
Nitra, , Slovakia
Nové Zámky, , Slovakia
Trnava, , Slovakia
Žilina, , Slovakia
Goyang-si, Gyeonggido, South Korea
Seongnam-si, Gyeonggido, South Korea
Incheon, Incheon Gwang''yeogsi, South Korea
Busan, , South Korea
Daegu, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Jung-gu Daejeon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Cadiz, Andalusia, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Sabadell, Barcelona, Spain
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
Ciudad Real, , Spain
Granada, , Spain
Madrid, , Spain
Pamplona, , Spain
Tarragona, , Spain
Gothenburg, , Sweden
Linköping, , Sweden
Malmo, , Sweden
Solna, , Sweden
Vaxjo, , Sweden
Basel, Canton of Basel-City, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Chur, Kanton Graubünden, Switzerland
Baden, , Switzerland
Bern, , Switzerland
Fribourg, , Switzerland
Geneva, , Switzerland
Lucerne, , Switzerland
Hsinchu, , Taiwan
Kaohsiung City, , Taiwan
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Khon Kaen, , Thailand
Songkhla, , Thailand
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Carlisle, Cumbria, United Kingdom
Hull, Humberside, United Kingdom
Harrow, London, United Kingdom
Doncaster, South Yorkshire, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Birmingham, West Midlands, United Kingdom
Leeds, West Yorkshire, United Kingdom
Worcester, Worcestershire, United Kingdom
Cambridge, , United Kingdom
Cheltenham, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Sheffield, , United Kingdom
Countries
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References
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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 Oct 23:e039752. doi: 10.1161/JAHA.124.039752. Online ahead of print.
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.
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.
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.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2014-005569-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17454
Identifier Type: -
Identifier Source: org_study_id