Trial Condition(s):
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 (VOYAGER PAD)
Bayer Identifier:
17454
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Age ≥50 - Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease - Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization
Exclusion Criteria
- Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg. - Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis. - Prior revascularization on the index leg within 10 days of the qualifying revascularization. - Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for >6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator’s opinion that require longer use. - Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Shreveport, United States, 71103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Montreal, Canada, H1T 2M4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kaohsiung, Taiwan, China, 813 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bucharest, Romania, 022322 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Targu Mures, Romania, 540124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pitesti, Romania, 110084 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cluj Napoca, Romania, 400001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bucharest, Romania, 011461 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bucharest, Romania, 010192 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lodz, Poland, 94-048 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lublin, Poland, 20-044 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Poznan, Poland, 61-848 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Warszawa, Poland, 02-097 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site UTRECHT, Netherlands, 3584 CX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site ENSCHEDE, Netherlands, 7611 JH | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site DEN BOSCH, Netherlands, 5223 GZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Prostejov, Czech Republic, 798 11 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bahia Blanca, Argentina, B8001HXM | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Porto, Portugal, 4099-001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Almada, Portugal, 2805-267 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lisboa, Portugal, 1169-1024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nyiregyhaza, Hungary, 4400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seongnam-si, South Korea, 13620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 152-703 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jung-gu Daejeon, South Korea, 35015 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Goyang-si, South Korea, 10326 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kumamoto, Japan, 860-0008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Itabashi-ku, Japan, 173-8610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Meguro-ku, Japan, 152-8902 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Beppu, Japan, 874-0011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hamada, Japan, 697-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kitakyushu, Japan, 805-0050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fuchu, Japan, 183-0003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Genève, Switzerland, 1205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Daegu, South Korea, 42472 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Daegu, South Korea, 700-712 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 05368 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 5, Czech Republic, 150 06 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Liberec, Czech Republic, 460 63 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Gyor, Hungary, 9023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cheltenham, United Kingdom, GL53 7AN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hull, United Kingdom, HU3 2JZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site London, United Kingdom, SW17 0QT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Carlisle, United Kingdom, CA2 7HY | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Worcester, United Kingdom, WR5 1DD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Doncaster, United Kingdom, DN2 5LT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Leeds, United Kingdom, LS1 3EX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Birmingham, United Kingdom, B9 5SS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Rosario, Argentina, S2000PBJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sofia, Bulgaria, 1407 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ruse, Bulgaria, 7002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sofia, Bulgaria, 1606 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Samokov, Bulgaria, 2000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Varna, Bulgaria, 9010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Linden, United States, 07036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Szombathely, Hungary, 9700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site London, Canada, ON N6A 5W9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site St. Jerome, Canada, J7Z 5T3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Chicoutimi, Canada, G7H 5H6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Montreal, Canada, H1T 1C8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site HEERLEN, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Oradea, Romania | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Timisoara, Romania, 300736 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ravenna, Italy, 48033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site POITIERS cedex, France, 86021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site STRASBOURG, France, 67091 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site TOULOUSE, France, 31300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site GRENOBLE, France, 38043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site RENNES CEDEX, France, 35033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site LIMOGES, France, 87042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site TOULOUSE, France, 31403 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site NICE, France, 06280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site MONTPELLIER CEDEX, France, 34295 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BORDEAUX, France, 33075 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site PARIS, France, 75634 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site PARIS CEDEX 15, France, 75908 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site CASTELNAU LE LEZ, France, 34170 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site CAEN CEDEX, France, 14033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lecce, Italy, 73100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cádiz, Spain, 11009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Busan, South Korea, 49201 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 06351 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Daejeon, South Korea, 301-723 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Amarillo, United States, 79106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fort Payne, United States, 35967 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Manchester, United Kingdom, M13 9WL | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Manchester, United Kingdom, M23 9LT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Harrow, United Kingdom, HA1 3UJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sheffield, United Kingdom, S5 7AU | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cambridge, United Kingdom, CB3 OLB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Krakow, Poland | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Gatineau, Canada, J8Y 6S8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ottawa, Canada, K1Y 4E9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Yambol, Bulgaria, 8600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tyler, United States, 75701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fort Wayne, United States, 46845 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hudson, United States, 34667 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Shreveport, United States, 71105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Dayton, United States, 45414 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Phoenix, United States, 85006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site York, United States, 17405 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Edinburg, United States, 78539 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Safety Harbor, United States, 34695 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lexington, United States, 40536 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Dallas, United States, 75226 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Midland, United States, 48670 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cincinnati, United States, 45267 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Charlotte, United States, 28204 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Wyoming, United States, 49519 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Freudenstadt, Germany, 72250 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ragusa, Italy, 97100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tainan, Taiwan, China, 704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bangkok, Thailand, 10330 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Khon Kaen, Thailand, 40002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Songkla, Thailand, 90110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bangkok, Thailand, 10400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nagakute, Japan, 480-1195 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Klagenfurt, Austria, 9020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Miyazaki, Japan, 880-2102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bangkok, Thailand | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site LE COUDRAY, France, 28630 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Avellino, Italy, 83100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 5, Czech Republic, 15006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kaunas, Lithuania, 45130 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Panevezys, Lithuania, 35144 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Liepaja, Latvia, LV-3414 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Riga, Latvia, LV-1002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Daugavpils, Latvia, LV-5417 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Riga, Latvia, 1038 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bratislava, Slovakia, 851 07 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nitra, Slovakia, 949 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bratislava, Slovakia, 83348 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Trnava, Slovakia, 91701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Dunajska Streda, Slovakia, 92901 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Zilina, Slovakia, 01001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kosice, Slovakia, 04001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site La Plata, Argentina, B1900ASM | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Varese, Italy, 21100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Vilnius, Lithuania, LT-10207 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bardejov, Slovakia, 085 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Nove Zamky, Slovakia, 940 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Córdoba, Argentina, X5006IKK | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Corrientes, Argentina, 3400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osaka, Japan, 530-8480 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sagamihara, Japan, 252-5188 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kagoshima, Japan, 890-8760 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osaka, Japan, 530-0012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Amagasaki, Japan, 660-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Takarazuka, Japan, 665-0873 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Minato, Japan, 108-0073 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kawagoe, Japan, 350-8550 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Covington, United States, 70433 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Córdoba, Argentina, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Belo Horizonte, Brazil, 30140-073 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Campinas, Brazil, 13060-080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Belo Horizonte, Brazil, 30110-090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fortaleza, Brazil, 60430 370 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Porto Alegre, Brazil, 90619900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Belo Horizonte, Brazil, 30140-062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Rio de Janeiro, Brazil, 20551-030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Belo Horizonte, Brazil, 30130-100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Porto Alegre, Brazil | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Denver, United States, 80220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Avondale, United States, 85388 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site VELDHOVEN, Netherlands, 5504 DB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site London, United Kingdom, W6 8RF | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taoyuan, Taiwan, China, 333423 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Junín, Argentina, B6000BHA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ciudad Auton. de Buenos Aires, Argentina, C1181ACL | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Clinton, United States, 20735 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jackson, United States, 39216 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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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
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 etiologyThe analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.Timeframe: Approximately 2 years
- Number of participants with TIMI (Thrombolysis in Myocardial Infarction) Major bleedingTo evaluate the overall safety and tolerability.Timeframe: Approximately 2 years
Secondary Outcome
- Number of participants with composite of MI, ischemic stroke, Coronary heart disease (CHD) death, ALI, and major amputation of a vascular etiologyThe analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.Timeframe: Approximately 2 years
- 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.Timeframe: Approximately 2 years
- Number of participants with hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic natureThe analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.Timeframe: Approximately 2 years
- Number of participants with composite of MI, ischemic stroke, All-cause mortality (ACM), ALI, and major amputation of a vascular etiologyThe analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.Timeframe: Approximately 2 years
- Number of participants with composite of MI, all-cause stroke, Cardiovascular (CV) death, Acute limb ischemia (ALI), and major amputation of a vascular etiologyThe analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.Timeframe: Approximately 2 years
- 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.Timeframe: Approximately 2 years
- Number of participants with venous thromboembolic (VTE) eventsThe analysis of study efficacy outcome events will be based on events as adjudicated by the Independent Central Adjudication Committee.Timeframe: Approximately 2 years
- Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleedingTimeframe: Approximately 2 years
- Number of participants with BARC (Bleeding Academic Research Consortium) Type 3b and above bleeding eventsTimeframe: Approximately 2 years
Additional Information
Not Available
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