check_circleStudy Completed

Peripheral Artery Disease

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

50 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
6564
Trial Dates
August 2015 - January 2020
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Shreveport, 71103, United States
Completed
Wellington, 33449, United States
Completed
Winston-Salem, 27103, United States
Withdrawn
Toledo, 43606, United States
Withdrawn
El Cajon, 92020, United States
Withdrawn
Cottonwood, 86326, United States
Completed
Muskegon, 49444, United States
Completed
Lansing, 48912, United States
Completed
Saint Louis, 63128, United States
Completed
Northridge, 91325, United States
Completed
Roseville, 95661, United States
Withdrawn
New Braunfels, 78130, United States
Completed
Camp Hill, 17011, United States
Completed
San Antonio, 78258, United States
Withdrawn
Moreno Valley, 92553, United States
Completed
Tupelo, 38801, United States
Completed
Kingwood, 77339, United States
Completed
Birmingham, 35294-0012, United States
Completed
Fort Wayne, 46804, United States
Completed
Glendale, 85340, United States
Withdrawn
Valparaiso, 46383, United States
Completed
Alexandria, 71301, United States
Completed
Arlington Heights, 60005, United States
Withdrawn
Corpus Christi, 78404, United States
Withdrawn
Windsor Heights, 50324, United States
Completed
Pensacola, 32501, United States
Completed
Clearwater, 33756, United States
Withdrawn
New Port Richey, 34653, United States
Completed
Teaneck, 07666, United States
Completed
Madison, 53713, United States
Completed
Saratoga Springs, 12866, United States
Withdrawn
Clearwater, 33756, United States
Withdrawn
Jackson, 38305, United States
Completed
Atlantis, 33462, United States
Completed
Hillsboro, 97123, United States
Completed
Tallahassee, 32308, United States
Withdrawn
Covington, 70433, United States
Completed
Huntsville, 77340, United States
Withdrawn
Voorhees, 08043, United States
Completed
Torrance, 90502, United States
Completed
Springfield, 62701, United States
Withdrawn
Rock Island, 61201-5351, United States
Withdrawn
Layton, 84041, United States
Completed
Wausau, 54401, United States
Withdrawn
Raleigh, 27610, United States
Completed
Lincoln, 68506, United States
Withdrawn
Salt Lake City, 84132, United States
Withdrawn
Fort Smith, 72901, United States
Withdrawn
Newark, 19713, United States
Completed
Mission Viejo, 92691, United States
Completed
Manitowoc, 54220, United States
Withdrawn
Bridgeport, 06610, United States
Completed
Gainesville, 32605, United States
Withdrawn
Owensboro, 42303, United States
Withdrawn
Worcester, 01655, United States
Completed
Lewiston, 04240, United States
Completed
Durham, 27710, United States
Withdrawn
Indianapolis, 46237, United States
Completed
Jacksonville, 32216, United States
Completed
Knoxville, 37934, United States
Completed
Bay City, 48708, United States
Completed
Ocala, 34474, United States
Withdrawn
Asheville, 28801, United States
Withdrawn
Providence, 02906, United States
Withdrawn
Bay City, 48708, United States
Withdrawn
Falls Church, 22042, United States
Completed
Greenville, 29657, United States
Withdrawn
Pittsburgh, 15240, United States
Withdrawn
Erie, 16502, United States
Withdrawn
Wormleysburg, 17043, United States
Completed
Philadelphia, 19104, United States
Completed
Erie, 16507, United States
Completed
Toledo, 43614, United States
Completed
Cincinnati, 45219, United States
Withdrawn
Columbus, 43215, United States
Completed
Springfield, 45505, United States
Withdrawn
Bronx, 10469, United States
Withdrawn
East Orange, 07918, United States
Withdrawn
Summit, 07901, United States
Completed
Flemington, 08822, United States
Completed
Lebanon, 03756-1000, United States
Completed
Chapel Hill, 27517, United States
Withdrawn
Raleigh, 27607, United States
Withdrawn
Marquette, 49855, United States
Withdrawn
Detroit, 48236, United States
Completed
Dearborn, 48126, United States
Withdrawn
Mount Clemens, 48043, United States
Withdrawn
Flint, 48503, United States
Completed
Detroit, 48201, United States
Withdrawn
Kalamazoo, 49048, United States
Withdrawn
Beltsville, 20705, United States
Completed
Dallas, 75216-7167, United States
Withdrawn
New Brunswick, 08901, United States
Completed
Barcelona, 08036, Spain
Completed
L'Hospitalet de Llobregat, 08907, Spain
Completed
Tarragona, 43005, Spain
Completed
Ciudad Real, 13005, Spain
Completed
Graz, 8036, Austria
Completed
Wien, 1140, Austria
Withdrawn
Baltimore, United States
Completed
Baltimore, 21201-1595, United States
Completed
Baltimore, 21218, United States
Withdrawn
Boston, 02118, United States
Withdrawn
Crestview Hills, 41017-5460, United States
Withdrawn
Indianapolis, 46290, United States
Completed
Merrillville, 46410, United States
Withdrawn
Tucker, 30084, United States
Withdrawn
Jacksonville, 32204, United States
Withdrawn
Tampa, 33613, United States
Withdrawn
Miami Beach, 33140, United States
Withdrawn
Jacksonville, 32216, United States
Completed
Miami, 33173, United States
Completed
Daytona Beach, 32117, United States
Completed
Washington, 20422, United States
Completed
Washington, 20007, United States
Completed
Kingwood, 77339, United States
Completed
Iowa City, 52242, United States
Completed
Urbana, 61801, United States
Completed
Springfield, 65807, United States
Withdrawn
Milwaukee, 53215, United States
Completed
Victoria, 77901, United States
Withdrawn
McAllen, 78503, United States
Withdrawn
Galveston, 77555-0587, United States
Withdrawn
Houston, 77030, United States
Completed
Austin, 78705, United States
Withdrawn
Waco, 76712, United States
Withdrawn
Houston, 77024, United States
Completed
Humble, 77338, United States
Withdrawn
San Antonio, 78217, United States
Completed
Rapid City, 57702, United States
Completed
Torino, 10126, Italy
Completed
Macerata, 62100, Italy
Completed
Perugia, 06132, Italy
Withdrawn
Tulsa, 74104, United States
Completed
Oklahoma City, 73135, United States
Withdrawn
Oklahoma City, 73104, United States
Completed
Minot, 58701, United States
Withdrawn
Kansas City, 64111, United States
Withdrawn
St. Louis, 63110, United States
Withdrawn
Columbia, 65201, United States
Completed
St. Louis, 63128, United States
Completed
Coon Rapids, 55433, United States
Completed
St. Cloud, 56303, United States
Withdrawn
New Orleans, 70121, United States
Withdrawn
Shreveport, 71111, United States
Withdrawn
Waterloo, 50702, United States
Withdrawn
Little Rock, 72211, United States
Completed
Alexander City, 35010, United States
Completed
Huntsville, 35801-4317, United States
Withdrawn
Birmingham, 35235, United States
Completed
Houston, 77030, United States
Withdrawn
La Jolla, 92037, United States
Withdrawn
Seattle, 98122, United States
Completed
Palo Alto, 94304, United States
Withdrawn
La Jolla, 92037, United States
Completed
Stanford, 94305, United States
Completed
Hamilton, L8L 2X2, Canada
Completed
Winnipeg, R2H 2A6, Canada
Completed
Leipzig, 04103, Germany
Completed
Kaiserslautern, 67657, Germany
Completed
Münster, 48149, Germany
Completed
Berlin, 10787, Germany
Completed
Bad Krozingen, 79189, Germany
Completed
Dresden, 01099, Germany
Completed
Frankfurt, 65929, Germany
Withdrawn
Riesa, 01589, Germany
Completed
GENT, 9000, Belgium
Completed
GENK, 3600, Belgium
Completed
Springfield, 62702, United States
Withdrawn
Brampton, L6Z 4N5, Canada
Completed
Minato-ku, 108-8329, Japan
Completed
Kitakyushu, 802-8555, Japan
Completed
Shibukawa, 377-0061, Japan
Completed
Kurume, 830-8577, Japan
Completed
Himeji, 671-1227, Japan
Completed
Matsuyama, 790-8524, Japan
Completed
Asahikwa, 078-8510, Japan
Completed
Hatsukaichi, 738-8503, Japan
Withdrawn
Fukuoka, 810-8563, Japan
Completed
Bydgoszcz, 85-094, Poland
Completed
Bunkyo-ku, 113-8519, Japan
Completed
Bologna, 40138, Italy
Completed
Firenze, 50134, Italy
Completed
Potenza, 85100, Italy
Completed
Coronel Suarez, B7540GHD, Argentina
Completed
Mar del Plata, 7600, Argentina
Completed
Rosario, S2000QID, Argentina
Completed
Buenos Aires, C1428ART, Argentina
Completed
Buenos Aires, C1119ACN, Argentina
Withdrawn
Hamburg, 20099, Germany
Completed
München, 80331, Germany
Completed
Darmstadt, 64276, Germany
Completed
Karlsbad, 76307, Germany
Completed
Mainz, 55131, Germany
Completed
Heidelberg, 69129, Germany
Completed
Dresden, 01067, Germany
Completed
Hamburg, 20246, Germany
Completed
München, 81675, Germany
Completed
München, 80336, Germany
Withdrawn
Leipzig, 04289, Germany
Completed
Krefeld, 47805, Germany
Completed
Karlsruhe, 76133, Germany
Completed
Rosenheim, 83022, Germany
Completed
Sonneberg, 96515, Germany
Completed
Bern, 3010, Switzerland
Completed
Luzern, 6000, Switzerland
Withdrawn
Zürich, 8091, Switzerland
Completed
St. John's, A1C 2H6, Canada
Completed
Quebec, G1L 3L5, Canada
Completed
Warszawa, 01-211, Poland
Completed
Szczecin, 70-111, Poland
Completed
Bialystok, 15_111, Poland
Withdrawn
Prague, 14021, Czechia
Completed
Hodonin, 69501, Czechia
Completed
Hradec kralove, 500 05, Czechia
Completed
Vratimov, 73932, Czechia
Completed
Olomouc, 775 20, Czechia
Withdrawn
Pardubice, 53002, Czechia
Completed
Warszawa, 01-868, Poland
Completed
Sapporo, 060-0031, Japan
Withdrawn
Sapporo, 060-0031, Japan
Completed
Gifu, 500-8717, Japan
Completed
Kladno, 27259, Czechia
Completed
Plzen, 30599, Czechia
Completed
København Ø, 2100, Denmark
Completed
Aarhus N, 8200, Denmark
Completed
Viborg, 8800, Denmark
Completed
Kolding, 6000, Denmark
Completed
Odense C, 5000, Denmark
Completed
Miskolc, 3526, Hungary
Completed
Budapest, 1115, Hungary
Completed
Kistarcsa, 2143, Hungary
Completed
Kaposvar, 7400, Hungary
Completed
Shizuoka, 420-8630, Japan
Completed
Pecs, 7624, Hungary
Completed
Budapest, 1085, Hungary
Completed
Sabadell, 08208, Spain
Completed
Brno, 656 91, Czechia
Completed
Praha 10, 10100, Czechia
Completed
A Coruña, 15006, Spain
Completed
Kobe, 651-0053, Japan
Completed
Itabashi-ku, 173-0015, Japan
Completed
Himeji, 670-0981, Japan
Completed
Bad Friedrichshall, 74177, Germany
Completed
Bremen, 28277, Germany
Withdrawn
Marburg, 35043, Germany
Withdrawn
Bad Bevensen, 29549, Germany
Completed
Erlangen, 91054, Germany
Withdrawn
Flensburg, 24939, Germany
Completed
Frankfurt, 60596, Germany
Withdrawn
Darmstadt, 64276, Germany
Withdrawn
Altenburg, 04600, Germany
Withdrawn
Berlin, 10787, Germany
Completed
Bad Nauheim, 61231, Germany
Completed
Lübeck, 23538, Germany
Completed
Düsseldorf, 40225, Germany
Completed
Ulm, 89081, Germany
Completed
Arnsberg, 59759, Germany
Completed
Berlin, 10713, Germany
Withdrawn
Jena, 07740, Germany
Withdrawn
Altenburg, 04600, Germany
Terminated
Dresden, 01307, Germany
Withdrawn
Barcelona, 08041, Spain
Withdrawn
Badalona, 08916, Spain
Withdrawn
Palma de Mallorca, 07120, Spain
Completed
Madrid, 28006, Spain
Completed
Granada, 18012, Spain
Completed
Pamplona, 31008, Spain
Completed
Ciudadela, 1702, Argentina
Completed
La Plata, 1900, Argentina
Completed
Buenos Aires, 1078, Argentina
Completed
Köln, 50937, Germany
Completed
Magdeburg, 39120, Germany
Completed
Immenstadt, 87509, Germany
Withdrawn
Heidelberg, 69120, Germany
Withdrawn
Merseburg, 06217, Germany
Withdrawn
Mainz, 55131, Germany
Completed
Wesel, 46483, Germany
Withdrawn
Münster, 48145, Germany
Withdrawn
Heide, 25746, Germany
Completed
LEUVEN, 3000, Belgium
Withdrawn
NAMUR, 5000, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
Malmö, 205 02, Sweden
Withdrawn
Västerås, 721 89, Sweden
Completed
Växjö, 351 85, Sweden
Completed
Solna, 171 76, Sweden
Completed
Wien, 1160, Austria
Completed
Linz, 4021, Austria
Completed
Innsbruck, 6020, Austria
Completed
Feldkirch, 6807, Austria
Withdrawn
Graz, 8036, Austria
Completed
Napoli, 80131, Italy
Completed
Roma, 00161, Italy
Completed
Reggio Emilia, 42100, Italy
Withdrawn
Piacenza, 29121, Italy
Withdrawn
Roma, 00135, Italy
Completed
Montreal, H2W 1T8, Canada
Completed
Montreal, H1T 2M4, Canada
Withdrawn
Barrie, L4M 5K3, Canada
Completed
Praha 2, 12808, Czechia
Completed
Taipei, 10002, Taiwan
Completed
Kaohsiung, 813, Taiwan
Completed
Bucharest, 022322, Romania
Completed
Targu Mures, 540124, Romania
Completed
Pitesti, 110084, Romania
Completed
Bucharest, 022322, Romania
Completed
Cluj Napoca, 400001, Romania
Completed
Bucharest, 011461, Romania
Completed
Bucharest, 010192, Romania
Completed
Lodz, 94-048, Poland
Completed
Lublin, 20-044, Poland
Completed
Poznan, 61-848, Poland
Completed
Warszawa, 02-097, Poland
Withdrawn
Orense, 32005, Spain
Withdrawn
ROTTERDAM, 3079 DZ, Netherlands
Completed
UTRECHT, 3584 CX, Netherlands
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
ENSCHEDE, 7611 JH, Netherlands
Completed
EINDHOVEN, 5623 EJ, Netherlands
Withdrawn
NIEUWEGEIN, 3435 CM, Netherlands
Withdrawn
BREDA, 4818 CK, Netherlands
Completed
DEN BOSCH, 5223 GZ, Netherlands
Completed
Prostejov, 798 11, Czechia
Completed
Buenos Aires, C1280AEB, Argentina
Completed
Bahia Blanca, B8001HXM, Argentina
Completed
Taipei, 11217, Taiwan
Withdrawn
Porto, 4100-180, Portugal
Withdrawn
Lisboa, 1649-035, Portugal
Completed
Porto, 4099-001, Portugal
Completed
Almada, 2805-267, Portugal
Completed
Porto, 4200-319, Portugal
Completed
Lisboa, 1169-1024, Portugal
Completed
Szekesfehervar, 8000, Hungary
Completed
Nyiregyhaza, 4400, Hungary
Completed
Seoul, 03722, Korea, Republic Of
Completed
Seongnam-si, 13620, Korea, Republic Of
Completed
Seoul, 152-703, Korea, Republic Of
Completed
Seoul, 137-701, Korea, Republic Of
Completed
Jung-gu Daejeon, 35015, Korea, Republic Of
Completed
Goyang-si, 10326, Korea, Republic Of
Completed
Seoul, Korea, Republic Of
Withdrawn
Yatsushiro, 866-8533, Japan
Completed
Kumamoto, 860-0008, Japan
Withdrawn
Fukui, 918-8503, Japan
Completed
Itabashi-ku, 173-8610, Japan
Withdrawn
Matsumoto, 390-8621, Japan
Completed
Meguro-ku, 152-8902, Japan
Completed
Beppu, 874-0011, Japan
Completed
Hamada, 697-8511, Japan
Completed
Kitakyushu, 805-0050, Japan
Completed
Fuchu, 183-0003, Japan
Completed
St. Gallen, 9007, Switzerland
Completed
Genève, 1205, Switzerland
Completed
Daegu, 42472, Korea, Republic Of
Completed
London, NW3 2QG, United Kingdom
Withdrawn
Dundee, DD1 9SY, United Kingdom
Completed
Daegu, 700-712, Korea, Republic Of
Completed
Seoul, 05368, Korea, Republic Of
Completed
Praha 5, 150 06, Czechia
Completed
Liberec, 460 63, Czechia
Completed
Szeged, 6725, Hungary
Completed
Gyor, 9023, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Bangkok, 10700, Thailand
Completed
Cheltenham, GL53 7AN, United Kingdom
Completed
Hull, HU3 2JZ, United Kingdom
Withdrawn
Leicester, LE1 5WW, United Kingdom
Completed
London, SW17 0QT, United Kingdom
Completed
Carlisle, CA2 7HY, United Kingdom
Completed
Worcester, WR5 1DD, United Kingdom
Completed
Doncaster, DN2 5LT, United Kingdom
Completed
Leeds, LS1 3EX, United Kingdom
Completed
Birmingham, B9 5SS, United Kingdom
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Kashihara, 634-8522, Japan
Withdrawn
Sapporo, 065-0027, Japan
Completed
Rosario, S2000PBJ, Argentina
Completed
Sofia, 1407, Bulgaria
Completed
Ruse, 7002, Bulgaria
Completed
Sofia, 1407, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Stara Zagora, 6000, Bulgaria
Completed
Sofia, 1407, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Sofia, 1431, Bulgaria
Completed
Samokov, 2000, Bulgaria
Completed
Sofia, 1606, Bulgaria
Completed
Varna, 9010, Bulgaria
Completed
Plovdiv, 4002, Bulgaria
Withdrawn
Sofia, 1000, Bulgaria
Completed
Linden, 07036, United States
Withdrawn
OVERPELT, 3900, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
BRUXELLES - BRUSSEL, 1090, Belgium
Completed
Szombathely, 9700, Hungary
Withdrawn
Jicin, 506 01, Czechia
Completed
London, ON N6A 5W9, Canada
Completed
St. Jerome, J7Z 5T3, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
Chicoutimi, G7H 5H6, Canada
Completed
Montreal, H1T 1C8, Canada
Completed
Kobe, 650-0047, Japan
Withdrawn
GRONINGEN, 9700 RB, Netherlands
Completed
HEERLEN, 6419 PC, Netherlands
Completed
Basel, 4031, Switzerland
Withdrawn
Frauenfeld, 8501, Switzerland
Completed
Budapest, 1106, Hungary
Completed
Oradea, Romania
Completed
Timisoara, 300736, Romania
Withdrawn
Cluj-Napoca, 400006, Romania
Completed
Ravenna, 48033, Italy
Completed
Palermo, 90127, Italy
Completed
POITIERS cedex, 86021, France
Completed
STRASBOURG, 67091, France
Completed
TOULOUSE, 31300, France
Completed
GRENOBLE, 38043, France
Completed
RENNES CEDEX, 35033, France
Withdrawn
AMIENS, 80000, France
Completed
LIMOGES, 87042, France
Completed
TOULOUSE, 31403, France
Completed
NICE, 06280, France
Completed
MONTPELLIER CEDEX, 34295, France
Completed
BORDEAUX, 33075, France
Completed
PARIS, 75634, France
Completed
PARIS CEDEX 15, 75908, France
Completed
CASTELNAU LE LEZ, 34170, France
Completed
CAEN CEDEX, 14033, France
Withdrawn
Lisboa, 1500-458, Portugal
Completed
Jena, 07740, Germany
Completed
Lecce, 73100, Italy
Completed
Cádiz, 11009, Spain
Completed
Busan, 49201, Korea, Republic Of
Completed
Seoul, 06351, Korea, Republic Of
Completed
Daejeon, 301-723, Korea, Republic Of
Completed
Amarillo, 79106, United States
Completed
Fort Payne, 35967, United States
Completed
Manchester, M13 9WL, United Kingdom
Completed
Manchester, M23 9LT, United Kingdom
Completed
Harrow, HA1 3UJ, United Kingdom
Completed
Sheffield, S5 7AU, United Kingdom
Completed
Cambridge, CB3 OLB, United Kingdom
Completed
Krakow, Poland
Completed
Gatineau, J8Y 6S8, Canada
Completed
Ottawa, K1Y 4E9, Canada
Completed
Yambol, 8600, Bulgaria
Completed
Jacksonville, 32209, United States
Withdrawn
Mobile, 36617, United States
Completed
Tyler, 75701, United States
Completed
Fort Wayne, 46845, United States
Completed
Hudson, 34667, United States
Completed
Shreveport, 71105, United States
Withdrawn
Philadelphia, 19106, United States
Withdrawn
Chicago, 60611, United States
Withdrawn
South Charleston, 25309, United States
Withdrawn
Tucson, 85724, United States
Completed
Dayton, 45414, United States
Withdrawn
Tullahoma, 37388, United States
Withdrawn
San Diego, 92120, United States
Withdrawn
Newark, 19713, United States
Withdrawn
Skokie, 60076, United States
Withdrawn
Largo, 33777, United States
Withdrawn
Tacoma, 98405-2433, United States
Withdrawn
Torrance, 90505, United States
Withdrawn
Tomball, 77375, United States
Withdrawn
Fort Wayne, 46804, United States
Withdrawn
Boston, 02115-6195, United States
Completed
Phoenix, 85006, United States
Completed
York, 17405, United States
Completed
Edinburg, 78539, United States
Completed
Safety Harbor, 34695, United States
Withdrawn
Hartford, 06102-5037, United States
Completed
Lexington, 40536, United States
Completed
Dallas, 75226, United States
Withdrawn
Stony Brook, 11794, United States
Completed
New York, 10029, United States
Withdrawn
Lexington, 40536, United States
Withdrawn
Minneapolis, 55455, United States
Completed
Midland, 48670, United States
Withdrawn
Oakbrook Terrace, 60181, United States
Completed
Cincinnati, 45267, United States
Completed
Charlotte, 28204, United States
Completed
Wyoming, 49519, United States
Withdrawn
Atlanta, 30308, United States
Completed
Lincoln, 68510, United States
Withdrawn
Clearwater, 33756, United States
Completed
Freudenstadt, 72250, Germany
Withdrawn
Napoli, 80131, Italy
Completed
Ragusa, 97100, Italy
Completed
Tainan, 704, Taiwan
Completed
Bangkok, 10330, Thailand
Completed
Khon Kaen, 40002, Thailand
Completed
Songkla, 90110, Thailand
Completed
Bangkok, 10400, Thailand
Completed
Nagakute, 480-1195, Japan
Withdrawn
Nagoya, 466-8560, Japan
Withdrawn
Bonn, 53105, Germany
Completed
Regensburg, 93053, Germany
Completed
Klagenfurt, 9020, Austria
Completed
Miyazaki, 880-2102, Japan
Completed
Bangkok, Thailand
Completed
LE COUDRAY, 28630, France
Completed
Avellino, 83100, Italy
Completed
Napoli, 80131, Italy
Completed
Milano, 20132, Italy
Withdrawn
Chieti, 66013, Italy
Withdrawn
Padova, 35128, Italy
Completed
Praha 5, 15006, Czechia
Completed
Kaunas, 45130, Lithuania
Completed
Panevezys, 35144, Lithuania
Completed
Kaunas, LT-50009, Lithuania
Completed
Vilnius, LT-08661, Lithuania
Completed
Liepaja, LV-3414, Latvia
Completed
Riga, LV-1002, Latvia
Completed
Daugavpils, LV-5417, Latvia
Completed
Riga, 1038, Latvia
Withdrawn
Bratislava, 813 69, Slovakia
Completed
Bratislava, 851 07, Slovakia
Completed
Nitra, 949 01, Slovakia
Completed
Bratislava, 83348, Slovakia
Completed
Trnava, 91701, Slovakia
Completed
Dunajska Streda, 92901, Slovakia
Completed
Trnava, 91701, Slovakia
Completed
Zilina, 01001, Slovakia
Completed
Kosice, 04001, Slovakia
Withdrawn
London, SE1 6LH, United Kingdom
Completed
La Plata, B1900ASM, Argentina
Completed
Varese, 21100, Italy
Completed
Vilnius, LT-10207, Lithuania
Completed
Bardejov, 085 01, Slovakia
Completed
Nove Zamky, 940 01, Slovakia
Completed
Córdoba, X5006IKK, Argentina
Completed
Corrientes, 3400, Argentina
Withdrawn
Poprad, 058 01, Slovakia
Withdrawn
Lakewood, 80228, United States
Completed
Osaka, 530-8480, Japan
Completed
Sagamihara, 252-5188, Japan
Completed
Kagoshima, 890-8760, Japan
Completed
Osaka, 530-0012, Japan
Completed
Amagasaki, 660-8511, Japan
Completed
Takarazuka, 665-0873, Japan
Completed
Minato, 108-0073, Japan
Completed
Kawagoe, 350-8550, Japan
Completed
Covington, 70433, United States
Completed
Córdoba, 5000, Argentina
Completed
Belo Horizonte, 30140-073, Brazil
Completed
Campinas, 13060-080, Brazil
Completed
Belo Horizonte, 30110-090, Brazil
Withdrawn
Tubarao, 88701-160, Brazil
Completed
Fortaleza, 60430 370, Brazil
Completed
Porto Alegre, 90619900, Brazil
Completed
Belo Horizonte, 30140-062, Brazil
Withdrawn
Sao Paulo, 04005-000, Brazil
Completed
Rio de Janeiro, 20551-030, Brazil
Withdrawn
Porto Alegre, 90050-170, Brazil
Completed
Belo Horizonte, 30130-100, Brazil
Completed
Porto Alegre, Brazil
Withdrawn
Belo Horizonte, 30150-240, Brazil
Withdrawn
Belo Horizonte, 30150-221, Brazil
Completed
Denver, 80220, United States
Withdrawn
Ocala, 34471, United States
Withdrawn
Athens, 30606, United States
Withdrawn
Newark, 07102-2094, United States
Completed
Avondale, 85388, United States
Completed
VELDHOVEN, 5504 DB, Netherlands
Completed
London, W6 8RF, United Kingdom
Completed
Taoyuan, 333423, Taiwan
Completed
Junín, B6000BHA, Argentina
Completed
Ciudad Auton. de Buenos Aires, C1181ACL, Argentina
Completed
Clinton, 20735, United States
Completed
Jackson, 39216, United States
Completed
New York, 10011, United States
Withdrawn
Lawrenceville, 30046, United States
Completed
Aurora, 80045, United States
Withdrawn
Clearwater, 33756, United States
Withdrawn
Sioux Falls, 57117, United States
Withdrawn
St. Louis, 63128, United States
Withdrawn
Somerset, 08873, United States
Completed
Omihachiman, 523-0082, Japan
Completed
Habikino, 583-0872, Japan
Completed
Philadelphia, 19140, United States
Completed
São José do Rio Preto, 15090, Brazil
Completed
Curitiba, 80230-130, Brazil
Completed
Tatui, 18270-170, Brazil
Completed
Passo Fundo, 99010-080, Brazil
Completed
Canoas, 92200-000, Brazil
Completed
Santo André, 09030-010, Brazil
Completed
Uberlândia, 38411-186, Brazil
Completed
São Bernardo do Campo, 09715-090, Brazil
Completed
Belo Horizonte, 30110-130, Brazil
Completed
Sofia, 1309, Bulgaria
Completed
Sofia, 1309, Bulgaria
Completed
Matsumoto, 390-8621, Japan
Withdrawn
Fukuoka, 814-0001, Japan
Completed
Matsusaka, 515-8566, Japan
Completed
Shanghai, 200032, China
Completed
Beijing, 100730, China
Completed
Changsha, 410011, China
Completed
Tianjin, 300000, China
Completed
Wuhan, 430030, China
Withdrawn
Shanghai, 200080, China
Withdrawn
Nanjing, China
Withdrawn
Shijiazhuang, 050051, China
Completed
Haikou, 570311, China
Withdrawn
Guiyang, 550004, China
Completed
Qingdao, 266003, China
Completed
Wenzhou, 325000, China
Withdrawn
Wuhan, 430030, China
Completed
Wuhan, 430014, China
Completed
Bratislava 37, 833 48, Slovakia
Withdrawn
Kosice, 04011, Slovakia
Completed
Ivano-Frankivsk, 76014, Ukraine
Completed
Vinnytsia, 21018, Ukraine
Completed
Ivano-Frankivsk, 76000, Ukraine
Completed
Kharkiv, 61018, Ukraine
Completed
Kyiv, 1601, Ukraine
Completed
Vinnytsia, 21018, Ukraine
Completed
Ivano-Frankivsk, 76000, Ukraine
Completed
Vancouver, V5Z 1M9, Canada
Completed
Montreal, Quebec, H4A 3J1, Canada
Withdrawn
Beijing, 100730, China
Withdrawn
East Orange, 07918, United States
Withdrawn
Urbana, 61801, United States
Withdrawn
Tampa, 33613, United States
Withdrawn
Voorhees, 08043, United States
Withdrawn
San Diego, 92120, United States
Withdrawn
Providence, 02906-2895, United States
Withdrawn
Tullahoma, 37388, United States
Withdrawn
Oakbrook Terrace, 60181, United States
Withdrawn
Detroit, 48236, United States
Withdrawn
Wormleysburg, 17043, United States
Withdrawn
Seattle, 98122, United States
Withdrawn
St. Louis, 63128, United States
Withdrawn
Indianapolis, 46237, United States
Withdrawn
Ogden, 84403-3150, United States
Withdrawn
San Gabriel, 91776, United States
Withdrawn
Memphis, 38103-2897, United States
Completed
Vila Nova de Gaia, 4434-502, Portugal
Completed
Ponta Delgada, 9500-370, Portugal
Completed
Saitama, 336-8522, Japan
Completed
Tomakomai, 053-8506, Japan
Completed
Iasi, 700732, Romania
Completed
Frankfurt, 60389, Germany
Withdrawn
Hannover, 30625, Germany
Completed
Fribourg, 1700, Switzerland
Completed
Baden, 5404, Switzerland
Withdrawn
Iowa City, 52242, United States
Withdrawn
Jacksonville, 32216, United States
Withdrawn
Hammond, 70403, United States
Completed
Beijing, 100083, China
Withdrawn
Baotou, 14040, China
Active, not recruiting
Beijing, 100144, China
Withdrawn
Shanghai, 200433, China
Completed
Taiyuan, 030001, China
Completed
Guangzhou, 510080, China
Completed
Kyoto, 615-8256, Japan
Completed
Wien, 1090, Austria
Completed
Elk Grove Village, 60007, United States
Completed
Zaporizhzhya, 69600, Ukraine
Completed
Lviv, 79010, Ukraine
Completed
Changchun, 130021, China
Withdrawn
Lanzhou, 730030, China
Completed
Guangzhou, 510630, China
Completed
Zhangzhou, 363000, China
Completed
Beijing, 100053, China
Completed
Nanjing, 210006, China
Withdrawn
Shanghai, 201700, China
Withdrawn
Changsha, 410013, China
Completed
Taizhou, 317000, China
Completed
Guangzhou, China
Completed
Zhongshan, 528403, China
Completed
Changzhou, 213003, China
Completed
Zhanjiang, 524001, China
Completed
Xi'an, 710038, China
Withdrawn
Xuzhou, 221351, China
Withdrawn
Beijing, 100037, China
Withdrawn
Nanjing, 210009, China
Completed
Beijing, 100853, China
Completed
Beijing, 100029, China
Withdrawn
Aurora, 60504, United States
Withdrawn
Aurora, 60504, United States
Completed
Bielefeld, 33604, Germany
Withdrawn
Santa Rosa, 95494, United States
Withdrawn
Bellevue, 98004-4623, United States
Withdrawn
Austell, 30106-6810, United States
Completed
Kiev, 3680, Ukraine
Completed
Osaka, 558-8558, Japan
Completed
KORTRIJK, 8500, Belgium
Completed
Morioka, 020-0066, Japan
Completed
Shanghai, 200040, China
Completed
Suginami-ku, 166-0001, Japan
Completed
Kyoto, 604-8401, Japan
Completed
Tver, 170036, Russian Federation
Withdrawn
Napoli, 80131, Italy
Withdrawn
ALKMAAR, 1815 JD, Netherlands
Completed
Tallinn, 11312, Estonia
Completed
Incheon, 21565, Korea, Republic Of
Completed
Burgas, 8000, Bulgaria
Completed
Panagyurishte, 4500, Bulgaria
Completed
Takamatsu, 760-8557, Japan
Completed
Sapporo, 064-8622, Japan
Completed
Katowice, 40-040, Poland
Completed
Tartu, 50406, Estonia
Completed
BORDEAUX, 33000, France
Completed
Hsinchu City, 300, Taiwan
Completed
Beijing, 100730, China
Completed
Santa Fe, S3000FWO, Argentina
Withdrawn
Burgas, 8000, Bulgaria
Completed
Ruse, 7013, Bulgaria
Completed
São Paulo, 01323-903, Brazil
Completed
Göteborg, 413 46, Sweden
Completed
Linköping, 582 85, Sweden
Completed
Rosario, 2000, Argentina
Completed
Barcelona, 08035, Spain
Completed
Córdoba, X5000AAX, Argentina
Completed
Tampere, 33521, Finland
Completed
Hefei, 230001, China
Completed
Wien, 1170, Austria
Completed
Changsha, 410008, China
Completed
Helsinki, 00290, Finland
Completed
Fuzhou, 350025, China
Completed
Lublin, 20-718, Poland
Completed
Wroclaw, 50-981, Poland
Completed
Dnipro, 49000, Ukraine
Completed
Kawasaki, 215-0026, Japan
Completed
Santa Rosa, 6300, Argentina
Completed
Gdynia, 81-338, Poland
Withdrawn
Ostrava - Poruba, 702 00, Czechia
Active, not recruiting
Chongqing, China
Completed
Oulu, 90220, Finland
Completed
San Isidro, B1642DCD, Argentina
Completed
Tallinn, 13419, Estonia
Completed
Novosibirsk, 630055, Russian Federation
Completed
Novosibirsk, 630087, Russian Federation
Completed
Voronezh, 394066, Russian Federation
Active, not recruiting
Kaohsiung, 82445, Taiwan
Completed
St. Petersburg, 195271, Russian Federation
Completed
Tomsk, 634012, Russian Federation
Completed
St. Petersburg, 194354, Russian Federation
Completed
Nizhny Novgorod, 603155, Russian Federation
Completed
Moscow, 105077, Russian Federation
Completed
Ryazan, 390026, Russian Federation
Completed
Belgrade, 11000, Serbia
Completed
Rostov-on-Don, 344022, Russian Federation
Withdrawn
Trois-Rivieres, G8Z 3R9, Canada
Completed
Kemerovo, 650002, Russian Federation
Completed
Belgrade, 11080, Serbia
Completed
Belgrade, 11040, Serbia
Completed
Nis, 18000, Serbia
Completed
Moscow, 117997, Russian Federation
Completed
Beograd, 11000, Serbia
Completed
Chur, 7000, Switzerland
Completed
St. Petersburg, 191015, Russian Federation
Completed
St. Petersburg, 194291, Russian Federation
Completed
Moscow, 129327, Russian Federation
Completed
Moscow, 115682, Russian Federation
Completed
San Martín, 1650, Argentina
Withdrawn
Suzhou, China
Withdrawn
Quilmes, 1878, Argentina
Withdrawn
Wien, 1090, Austria
Completed
Saint-Petersburg, 197374, Russian Federation
Withdrawn
Lublin, 20-081, Poland
Withdrawn
Warszawa, 01-809, Poland
Withdrawn
Moscow, 129128, Russian Federation
Withdrawn
Odessa, 65025, Ukraine
Withdrawn
Kharkiv, 61176, Ukraine
Withdrawn
Uzhgorod, 8801, Ukraine
Withdrawn
Bangkok, 10310, Thailand

Primary 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
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with TIMI (Thrombolysis in Myocardial Infarction) Major bleeding
    To evaluate the overall safety and tolerability.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of participants with composite of MI, ischemic stroke, Coronary heart disease (CHD) death, ALI, and major amputation of a vascular etiology
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with composite of MI, ischemic stroke, All-cause mortality (ACM), ALI, and major amputation of a vascular etiology
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with composite of MI, all-cause stroke, Cardiovascular (CV) death, Acute limb ischemia (ALI), and major amputation of a vascular etiology
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of mortality (all-cause)
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with venous thromboembolic (VTE) events
    The analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.
    date_rangeTime Frame:
    Approximately 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding
    date_rangeTime Frame:
    Approximately 2 years
  • Number of participants with BARC (Bleeding Academic Research Consortium) Type 3b and above bleeding events
    date_rangeTime Frame:
    Approximately 2 years

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2