check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

11899

ClinicalTrials.gov Identifier:

NCT00439725

EudraCT Number:

2006-004494-96

EU CT Number:

Not Available
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 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).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
  • - 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
1197
Trial Dates
February 2007 - September 2009
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Tübingen, 72076, Germany
Completed
Karlsbad, 76307, Germany
Completed
Mannheim, 68167, Germany
Withdrawn
Berlin, 12099, Germany
Completed
Augsburg, 86156, Germany
Withdrawn
Hamburg, 20251, Germany
Withdrawn
Frankfurt, 60596, Germany
Withdrawn
Frankfurt, 60596, Germany
Withdrawn
Halle, 06120, Germany
Withdrawn
Wiesbaden, 65183, Germany
Withdrawn
Leipzig, 04289, Germany
Withdrawn
Würzburg, 97080, Germany
Withdrawn
Rotenburg, 27342, Germany
Withdrawn
Neckargemünd, 69151, Germany
Withdrawn
Bruchsal, 76646, Germany
Withdrawn
Berlin, 10713, Germany
Withdrawn
Dresden, 01307, Germany
Completed
London, SE5 9RS, United Kingdom
Withdrawn
London, SE1 7EH, United Kingdom
Withdrawn
Edinburgh, EH16 4SA, United Kingdom
Withdrawn
Romford, RM7 0AG, United Kingdom
Completed
London, United Kingdom
Withdrawn
Melbourne, 32901, United States
Completed
Spokane, 99204, United States
Completed
Oklahoma City, 73104, United States
Withdrawn
Fredericksburg, 22401, United States
Withdrawn
Salt Lake City, 84132, United States
Completed
Albuquerque, 87108, United States
Withdrawn
Boston, 02215, United States
Withdrawn
Darmstadt, 64297, Germany
Completed
Heidelberg, 69115, Germany
Withdrawn
München, 81377, Germany
Withdrawn
Witten, 58455, Germany
Completed
Paderborn, 33098, Germany
Completed
Magdeburg, 39112, Germany
Withdrawn
Gießen, 35392, Germany
Withdrawn
Homburg, 66421, Germany
Withdrawn
Dresden, 01307, Germany
Withdrawn
Hannover, 30625, Germany
Withdrawn
Düsseldorf, 40225, Germany
Completed
München, 80331, Germany
Withdrawn
Essen, 45122, Germany
Withdrawn
Los Angeles, 90095, United States
Withdrawn
Corsicana, 75110, United States
Withdrawn
Covington, 70433, United States
Completed
Greensboro, 27401, United States
Withdrawn
Miami, 33136, United States
Withdrawn
VALENCIENNES CEDEX, 59322, France
Withdrawn
NIMES CEDEX 9, 30029, France
Completed
LIMOGES, 87042, France
Completed
DIJON, 21000, France
Completed
COLOMBES, 92700, France
Completed
MONTPELLIER CEDEX, 34295, France
Completed
STRASBOURG CEDEX, 67091, France
Completed
AGEN CEDEX 9, 47923, France
Withdrawn
LILLE, 59000, France
Completed
AMIENS, 80000, France
Withdrawn
Greifswald, 17475, Germany
Withdrawn
Homburg, 66424, Germany
Withdrawn
Tübingen, 72076, Germany
Withdrawn
Mainz, 55131, Germany
Withdrawn
Soest, 59494, Germany
Withdrawn
Chelmsford, CM1 5ET, United Kingdom
Withdrawn
London, W1T 4EU, United Kingdom
Withdrawn
Liverpool, L7 8XP, United Kingdom
Withdrawn
Plymouth, PL6 8DH, United Kingdom
Completed
Isleworth, TW7 6AF, United Kingdom
Withdrawn
Bay Pines, 33744, United States
Withdrawn
Decatur, 30033, United States
Completed
San Antonio, 78229, United States
Completed
Chapel Hill, 27599-7035, United States
Completed
Idaho Falls, 83404, United States
Withdrawn
Grenoble, 38028, France
Withdrawn
Orthez, 64300, France
Withdrawn
Roanne, 42328, France
Completed
Wroclaw, 50-326, Poland
Completed
Bialystok, 15-276, Poland
Completed
Krakow, 31-066, Poland
Withdrawn
Warszawa, 02-097, Poland
Completed
Warszawa, 01-138, Poland
Withdrawn
Wroclaw, 51-124, Poland
Completed
Lodz, 90-153, Poland
Withdrawn
Poznan, 61-848, Poland
Withdrawn
Warszawa, 04-479, Poland
Withdrawn
Torun, 87-100, Poland
Completed
Pavia, 27100, Italy
Completed
Venezia, 30122, Italy
Completed
Milano, 20132, Italy
Completed
Bologna, 40138, Italy
Completed
Greensboro, 27403, United States
Withdrawn
Redlands, 92373, United States
Completed
Baltimore, 21215-5271, United States
Withdrawn
Burlington, 05401, United States
Completed
Pittsburgh, 15224, United States
Withdrawn
Miami, 33136-1096, United States
Completed
SAINT ETIENNE, 42055, France
Completed
VERNON, 27200, France
Withdrawn
TOURS, 37044, France
Withdrawn
BORDEAUX, 33075, France
Withdrawn
PARIS, 75877, France
Withdrawn
PARIS CEDEX 15, 75908, France
Withdrawn
PARIS, 75004, France
Completed
Chieti, 66013, Italy
Completed
Parma, 43126, Italy
Withdrawn
Alcorcón, 28922, Spain
Completed
Xàtiva, 46800, Spain
Withdrawn
Madrid, 28034, Spain
Completed
Pamplona, 31008, Spain
Withdrawn
Toronto, M6R 1B5, Canada
Withdrawn
Winnipeg, R2H 2A6, Canada
Completed
LEUVEN, 3000, Belgium
Withdrawn
DUFFEL, 2570, Belgium
Withdrawn
NAMUR, 5000, Belgium
Completed
LIEGE, 4000, Belgium
Withdrawn
GENK, 3600, Belgium
Withdrawn
DEN BOSCH, 5223 GZ, Netherlands
Withdrawn
ENSCHEDE, 7511 JX, Netherlands
Completed
ZWOLLE, 8025 AB, Netherlands
Withdrawn
CRETEIL, 94000, France
Completed
BREST CEDEX, 29609, France
Completed
CLAMART, 92141, France
Completed
GRENOBLE, 38043, France
Completed
NANTES, 44000, France
Completed
ANGERS CEDEX 01, 49033, France
Completed
CLERMONT FERRAND, 63000, France
Withdrawn
PARIS, 75475, France
Withdrawn
PIERRE BENITE, 69495, France
Completed
VANDOEUVRE LES NANCY, 54511, France
Completed
ARRAS, 62000, France
Withdrawn
TOULOUSE, 31403, France
Withdrawn
TOULON, 83000, France
Completed
CASTELNAU LE LEZ, 34170, France
Withdrawn
ROUEN CEDEX, 76031, France
Withdrawn
Warszawa, 02-097, Poland
Completed
AMSTERDAM, 1105 AZ, Netherlands
Completed
ARNHEM, 6815 AD, Netherlands
Completed
HOOFDDORP, 2134 TM, Netherlands
Withdrawn
DORDRECHT, 3318 AT, Netherlands
Withdrawn
MAASTRICHT, 6229 HX, Netherlands
Completed
Borås, 501 82, Sweden
Completed
Göteborg, 413 45, Sweden
Completed
Sundsvall, 851 86, Sweden
Completed
Västervik, 593 81, Sweden
Completed
Aarhus C, 8000, Denmark
Completed
Fredrikstad, 1603, Norway
Completed
Rud, 1309, Norway
Withdrawn
Oslo, 0514, Norway
Completed
Oslo, 0407, Norway
Completed
Pretoria, 0084, South Africa
Withdrawn
CAPE TOWN, 7500, South Africa
Withdrawn
Bydgoszcz, 85-168, Poland
Completed
Wroclaw, 51-124, Poland
Withdrawn
Krakow, 31-066, Poland
Completed
Wroclaw, 50-326, Poland
Withdrawn
Lublin, 20-081, Poland
Withdrawn
Katowice, 40-365, Poland
Withdrawn
Gdansk, 80-952, Poland
Withdrawn
Poznan, 60-631, Poland
Completed
Milano, 20142, Italy
Completed
Napoli, 80131, Italy
Completed
Piacenza, 29121, Italy
Completed
Padova, 35128, Italy
Completed
Palermo, 90127, Italy
Completed
Barcelona, 08036, Spain
Completed
Barcelona, 08025, Spain
Completed
Girona, 17007, Spain
Completed
Terrassa, 08221, Spain
Completed
Somerset West, 7130, South Africa
Completed
Roodepoort, 1724, South Africa
Withdrawn
Pretoria, 0157, South Africa
Completed
Pretoria, 0181, South Africa
Withdrawn
Johannesburg, 2193, South Africa
Completed
Johannesburg, 2193, South Africa
Completed
Ostrava-Poruba, 708 52, Czech Republic
Completed
Usti nad Lebem, 401 13, Czech Republic
Completed
Holon, 58100, Israel
Withdrawn
Zefat, 1311001, Israel
Completed
Kfar Saba, 4428164, Israel
Withdrawn
Haifa, 3339419, Israel
Withdrawn
Jerusalem, 9112001, Israel
Withdrawn
Beer Sheva, 8410101, Israel
Withdrawn
Sydney, 2031, Australia
Withdrawn
Fuenlabrada, 28942, Spain
Withdrawn
YVOIR, 5530, Belgium
Withdrawn
LIER, 2500, Belgium
Withdrawn
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Withdrawn
Sint-Truiden, 3800, Belgium
Withdrawn
HASSELT, 3500, Belgium
Completed
GENT, 9000, Belgium
Completed
ZOTTEGEM, 9620, Belgium
Withdrawn
ROTTERDAM, 3083 AN, Netherlands
Withdrawn
ZWIJNDRECHT, 3331 LZ, Netherlands
Completed
GRONINGEN, 9713 GZ, Netherlands
Completed
Göteborg, 416 85, Sweden
Completed
Jönköping, 551 85, Sweden
Withdrawn
Hellerup, 2900, Denmark
Completed
Frederiksberg, 2000F, Denmark
Completed
Braedstrup, 8740, Denmark
Completed
Adelaide, 5042, Australia
Completed
Woolloongabba, 4102, Australia
Completed
Kogarah, 2217, Australia
Withdrawn
Prahran, 3181, Australia
Completed
Melbourne, 3135, Australia
Withdrawn
Southport, 4215, Australia
Completed
Concord, 2139, Australia
Completed
Garran, 2605, Australia
Completed
Geelong, 3220, Australia
Completed
Gosford, 2250, Australia
Completed
Sydney, 2229, Australia
Completed
Box Hill, 3128, Australia
Completed
LISMORE, 2480, Australia
Completed
Brisbane, 4029, Australia
Completed
Salzburg, 5020, Austria
Completed
Graz, 8036, Austria
Completed
Johannesburg, 2191, South Africa
Completed
Johannesburg, 2193, South Africa
Completed
Worcester, 6850, South Africa
Completed
Pretoria, 0157, South Africa
Withdrawn
Cape Town, 7460, South Africa
Completed
Johannesburg, 2157, South Africa
Withdrawn
Praha 4, 140 21, Czech Republic
Completed
Prague 5, 150 00, Czech Republic
Withdrawn
Brno, 65691, Czech Republic
Completed
Ostrava, 728 80, Czech Republic
Completed
Praha 1, 110 00, Czech Republic
Completed
Praha 2, 12808, Czech Republic
Completed
Kladno, 27259, Czech Republic
Withdrawn
Karlovy Vary, 360 00, Czech Republic
Completed
Afula, 1834111, Israel
Withdrawn
Nyiregyhaza, 4400, Hungary
Completed
Kecskemet, 6000, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Kistarcsa, 2143, Hungary
Completed
Szentes, 6600, Hungary
Completed
Curitiba, 80050-350, Brazil
Withdrawn
Sorocaba, 18031-000, Brazil
Completed
São Paulo, 01323-001, Brazil
Withdrawn
Porto Alegre, Brazil
Completed
São Paulo, 04039-004, Brazil
Completed
Uberaba, 38010 380, Brazil
Withdrawn
Botucatu, 18618 970, Brazil
Completed
Shanghai, 200032, China
Completed
shanghai, 200001, China
Withdrawn
guangzhou, 510080, China
Completed
Haifa, 3109601, Israel
Completed
Ashkelon, 7827804, Israel
Terminated
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
Tel Aviv, 64239, Israel
Completed
Haifa, 3436212, Israel
Withdrawn
Rehovot, 7610001, Israel
Completed
St Leonards, 2065, Australia
Completed
Redcliffe, 4020, Australia
Withdrawn
Fremantle, 6160, Australia
Completed
Clayton, 3168, Australia
Completed
Adelaide, 5011, Australia
Completed
Melbourne, 3181, Australia
Completed
Perth, 6000, Australia
Completed
Wien, 1140, Austria
Completed
Feldkirch, 6807, Austria
Completed
Wien, 1090, Austria
Withdrawn
Budapest, 1096, Hungary
Withdrawn
Beijing, 100853, China
Completed
Beijing, 100029, China
Completed
Beijing, 100730, China
Withdrawn
Beijing, 100044, China
Withdrawn
Beijing, 100038, China
Withdrawn
Semarang, 50241, Indonesia
Withdrawn
Daegu, 700721, Korea, Republic Of
Withdrawn
Seoul, 03722, Korea, Republic Of
Withdrawn
Seoul, 06591, Korea, Republic Of
Withdrawn
Chur, 7000, Switzerland
Withdrawn
Seinäjoki, 60220, Finland
Completed
Pune, 411001, India
Withdrawn
New Delhi, 110060, India
Withdrawn
Kolkata, 700029, India
Completed
Miskolc, 3526, Hungary
Completed
Budapest, 1115, Hungary
Completed
Szombathely, 9700, Hungary
Withdrawn
Sao Paulo, 04023-061, Brazil
Completed
Rio de Janeiro, 20551-030, Brazil
Completed
Londrina, 86038440, Brazil
Withdrawn
São Paulo, 01509-900, Brazil
Completed
Beijing, 100020, China
Completed
shenyang, 110016, China
Withdrawn
Beijing, 100037, China
Withdrawn
Shanghai, 200433, China
Withdrawn
Wuhan, 430022, China
Completed
Suzhou, 215004, China
Completed
Shanghai, 200433, China
Completed
New Delhi, 110060, India
Withdrawn
Taipei, 10002, Taiwan
Withdrawn
Taoyuan, 333, Taiwan
Withdrawn
Taipei, 11217, Taiwan
Completed
Quezon City, 0850, Philippines
Completed
Singapore, 169608, Singapore
Completed
Christchurch, 8011, New Zealand
Completed
Auckland, 1023, New Zealand
Completed
Wellington South, 6021, New Zealand
Withdrawn
Harbin, 150001, China
Withdrawn
Jakarta, 10430, Indonesia
Withdrawn
Bandung, 40161, Indonesia
Completed
Medan, 20152, Indonesia
Withdrawn
Daegu, 705-718, Korea, Republic Of
Withdrawn
Daegu, 41931, Korea, Republic Of
Withdrawn
Seoul, 03080, Korea, Republic Of
Completed
Luzern, 6000, Switzerland
Completed
Genéve 14, 1211, Switzerland
Withdrawn
Lugano, 6903, Switzerland
Withdrawn
Zürich, 8091, Switzerland
Withdrawn
Bruderholz, 4101, Switzerland
Withdrawn
Mumbai, 400008, India
Withdrawn
Mumbai, 400016, India
Completed
Hyderabad, 500082, India
Completed
Kochi, 682026, India
Withdrawn
Tainan, 704, Taiwan
Withdrawn
Kaohsiung, 807, Taiwan
Withdrawn
Hong Kong, Hong Kong
Completed
Selangor, 68000, Malaysia
Completed
Quezon City, 1102, Philippines
Completed
Singapore, 308433, Singapore
Completed
Auckland, 0622, New Zealand
Completed
Palmerston North, 4414, New Zealand
Completed
Pathumwan, Bangkok, 10330, Thailand
Completed
Bangkok, 10400, Thailand
Withdrawn
Bangkok, 10700, Thailand
Completed
Innsbruck, 6020, Austria

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 treatment
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    No

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 treatment
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    No
  • 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 treatment
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    No
  • 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 treatment
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with recurrent VTE (PE or DVT) until the intended end of study treatment
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with recurrent DVT until the intended end of study treatment
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with major bleeding
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants with clinically relevant bleeding
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants with all death
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants with other vascular events
    date_rangeTime Frame:
    6- or 12-month study treatment period
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find the definition for Deep Vein Thrombosis [DVT].Click here to find the definition for Pulmonary Embolism [PE].Click here to find results for studies related to Bayer Healthcare products.Click here and search for information of Bayer products for Europe