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
| Locations | Status | |
|---|---|---|
Locations Investigative Site Karlsbad, Germany, 76307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mannheim, Germany, 68167 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Augsburg, Germany, 86156 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE5 9RS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99204 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oklahoma City, United States, 73104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paderborn, Germany, 33098 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80331 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greensboro, United States, 27401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIMOGES, France, 87042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DIJON, France, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COLOMBES, France, 92700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER CEDEX, France, 34295 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STRASBOURG CEDEX, France, 67091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AGEN CEDEX 9, France, 47923 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMIENS, France, 80000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Isleworth, United Kingdom, TW7 6AF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chapel Hill, United States, 27599-7035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-326 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-066 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 01-138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 90-153 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Venezia, Italy, 30122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greensboro, United States, 27403 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21215-5271 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SAINT ETIENNE, France, 42055 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VERNON, France, 27200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chieti, Italy, 66013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parma, Italy, 43126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xàtiva, Spain, 46800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pamplona, Spain, 31008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BREST CEDEX, France, 29609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLAMART, France, 92141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRENOBLE, France, 38043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES, France, 44000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANGERS CEDEX 01, France, 49033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT FERRAND, France, 63000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VANDOEUVRE LES NANCY, France, 54511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ARRAS, France, 62000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CASTELNAU LE LEZ, France, 34170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ARNHEM, Netherlands, 6815 AD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HOOFDDORP, Netherlands, 2134 TM | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Borås, Sweden, 501 82 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sundsvall, Sweden, 851 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Västervik, Sweden, 593 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus C, Denmark, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fredrikstad, Norway, 1603 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rud, Norway, 1309 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oslo, Norway, 0407 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 51-124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Piacenza, Italy, 29121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Girona, Spain, 17007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Terrassa, Spain, 08221 | Status Completed | Contact Us: E-mail: [email protected]com Phone: Not Available |
Locations Investigative Site Somerset West, South Africa, 7130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roodepoort, South Africa, 1724 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava-Poruba, Czech Republic, 708 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Usti nad Lebem, Czech Republic, 401 13 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holon, Israel, 58100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZOTTEGEM, Belgium, 9620 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9713 GZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 416 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jönköping, Sweden, 551 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frederiksberg, Denmark, 2000F | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Braedstrup, Denmark, 8740 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woolloongabba, Australia, 4102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kogarah, Australia, 2217 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Concord, Australia, 2139 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Garran, Australia, 2605 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Geelong, Australia, 3220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gosford, Australia, 2250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sydney, Australia, 2229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Box Hill, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LISMORE, Australia, 2480 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2191 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Worcester, South Africa, 6850 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0157 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2157 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prague 5, Czech Republic, 150 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava, Czech Republic, 728 80 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 1, Czech Republic, 110 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kladno, Czech Republic, 27259 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kecskemet, Hungary, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kistarcsa, Hungary, 2143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szentes, Hungary, 6600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Curitiba, Brazil, 80050-350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 01323-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 04039-004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uberaba, Brazil, 38010 380 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site shanghai, China, 200001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7827804 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 64239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Leonards, Australia, 2065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Redcliffe, Australia, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perth, Australia, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1140 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Feldkirch, Austria, 6807 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pune, India, 411001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miskolc, Hungary, 3526 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szombathely, Hungary, 9700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rio de Janeiro, Brazil, 20551-030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Londrina, Brazil, 86038440 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site shenyang, China, 110016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suzhou, China, 215004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Delhi, India, 110060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quezon City, Philippines, 0850 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 169608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Christchurch, New Zealand, 8011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wellington South, New Zealand, 6021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medan, Indonesia, 20152 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Luzern, Switzerland, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genéve 14, Switzerland, 1211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hyderabad, India, 500082 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kochi, India, 682026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Selangor, Malaysia, 68000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quezon City, Philippines, 1102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 308433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 0622 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palmerston North, New Zealand, 4414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pathumwan, Bangkok, Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | 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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