Trial Condition(s):
Venous Thromboembolism
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
Bayer Identifier:
11899
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).
Inclusion Criteria
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Exclusion Criteria
- Legal lower age limitations (country specific) - Indication for VKA other than DVT and/or PE - Patients in whom anticoagulant treatment for their index PE or DVT should be continued - Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
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 Karlsbad, Germany, 76307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Augsburg, Germany, 86156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paderborn, Germany, 33098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80331 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greensboro, United States, 27401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIMOGES, France, 87042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DIJON, France, 21000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COLOMBES, France, 92700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER CEDEX, France, 34295 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STRASBOURG CEDEX, France, 67091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AGEN CEDEX 9, France, 47923 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMIENS, France, 80000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Isleworth, United Kingdom, TW7 6AF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chapel Hill, United States, 27599-7035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-326 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 01-138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 90-153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Venezia, Italy, 30122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greensboro, United States, 27403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21215-5271 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SAINT ETIENNE, France, 42055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VERNON, France, 27200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chieti, Italy, 66013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parma, Italy, 43126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xàtiva, Spain, 46800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BREST CEDEX, France, 29609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLAMART, France, 92141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRENOBLE, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES, France, 44000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANGERS CEDEX 01, France, 49033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT FERRAND, France, 63000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VANDOEUVRE LES NANCY, France, 54511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ARRAS, France, 62000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CASTELNAU LE LEZ, France, 34170 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ARNHEM, Netherlands, 6815 AD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HOOFDDORP, Netherlands, 2134 TM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Borås, Sweden, 501 82 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sundsvall, Sweden, 851 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Västervik, Sweden, 593 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus C, Denmark, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fredrikstad, Norway, 1603 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rud, Norway, 1309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oslo, Norway, 0407 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 51-124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Piacenza, Italy, 29121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Girona, Spain, 17007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Terrassa, Spain, 08221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roodepoort, South Africa, 1724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava-Poruba, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Usti nad Lebem, Czech Republic, 401 13 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZOTTEGEM, Belgium, 9620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frederiksberg, Denmark, 2000F | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Braedstrup, Denmark, 8740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woolloongabba, Australia, 4102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kogarah, Australia, 2217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3135 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Concord, Australia, 2139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Garran, Australia, 2605 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Geelong, Australia, 3220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gosford, Australia, 2250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sydney, Australia, 2229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LISMORE, Australia, 2480 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2191 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prague 5, Czech Republic, 150 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava, Czech Republic, 728 80 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 1, Czech Republic, 110 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kladno, Czech Republic, 27259 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kecskemet, Hungary, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kistarcsa, Hungary, 2143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szentes, Hungary, 6600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Curitiba, Brazil, 80050-350 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 01323-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Uberaba, Brazil, 38010 380 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site shanghai, China, 200001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7827804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Redcliffe, Australia, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perth, Australia, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Feldkirch, Austria, 6807 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Beijing, China, 100029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pune, India, 411001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miskolc, Hungary, 3526 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Pathumwan, Bangkok, Thailand, 10330 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Percentage of participants with symptomatic recurrent venous thromboembolism [VTE] (i.e. the composite of recurrent deep vein thrombosis [DVT] or fatal or non-fatal pulmonary embolism [PE]) until the intended end of study treatmentTimeframe: 6- or 12-month study treatment period
Secondary Outcome
- Percentage of participants with the composite variable comprising recurrent DVT, non-fatal PE and all cause mortality until the intended end of study treatmentTimeframe: 6- or 12-month study treatment period
- Percentage of participants with the composite variable comprising recurrent DVT, non-fatal PE, all cause mortality, strokes and myocardial infarctions until the intended end of study treatmentTimeframe: 6- or 12-month study treatment period
- Percentage of participants with net clinical benefit as composite of recurrent DVT or non-fatal or fatal PE and major bleeding events until the intended end of study treatmentTimeframe: 6- or 12-month study treatment period
- Percentage of participants with recurrent VTE (PE or DVT) until the intended end of study treatmentTimeframe: 6- or 12-month study treatment period
- Percentage of participants with recurrent DVT until the intended end of study treatmentTimeframe: 6- or 12-month study treatment period
- Percentage of participants with major bleedingTimeframe: 6- or 12-month study treatment period
- Percentage of participants with clinically relevant bleedingTimeframe: 6- or 12-month study treatment period
- Percentage of participants with all deathTimeframe: 6- or 12-month study treatment period
- Percentage of participants with other vascular eventsTimeframe: 6- or 12-month study treatment period
Additional Information
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