check_circleStudy Completed

Prevention, Venous thromboembolism

Bayer Identifier:

11356

ClinicalTrials.gov Identifier:

NCT00361894

EudraCT Number:

2005-004620-40

EU CT Number:

Not Available
Regulation of coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement.

Trial purpose

The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement
  • - Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Trial summary

Enrollment Goal
2531
Trial Dates
February 2006 - January 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Frankurt am Main, 60528, Germany
Completed
Rheinfelden, 79618, Germany
Completed
Witten, 58455, Germany
Completed
Bad Mergentheim, 97980, Germany
Completed
PARIS CEDEX 19, 75019, France
Completed
LIEVIN, 62806, France
Completed
BOIS-GUILLAUME, 76230, France
Completed
NICE, 06000, France
Completed
MONACO, 98000, France
Completed
SOYAUX, 16800, France
Completed
NICE, 06000, France
Completed
Bydgoszcz, 85-094, Poland
Completed
Gdansk, 80-803, Poland
Completed
Krakow, 31-826, Poland
Completed
Lublin, 20-090, Poland
Completed
Fürth, 90766, Germany
Completed
Frankfurt, 65929, Germany
Completed
Garmisch-Partenkirchen, 82467, Germany
Completed
Sommerfeld, 16766, Germany
Completed
Düsseldorf, 40225, Germany
Completed
Bremen, 28177, Germany
Completed
Würzburg, 97080, Germany
Completed
PARIS CEDEX 14, 75877, France
Completed
STRASBOURG, 67098, France
Completed
NANTES CEDEX, 44277, France
Completed
MARSEILLE, 13008, France
Completed
CLERMONT FERRAND, 63050, France
Completed
PARIS, 75014, France
Completed
PARIS CEDEX 20, 75960, France
Completed
Szczecin, 71-252, Poland
Completed
Lublin, 20-718, Poland
Completed
Roma, 00168, Italy
Completed
Alghero, 07041, Italy
Completed
Milano, 20097, Italy
Completed
Padova, 35127, Italy
Completed
Udine, 33100, Italy
Completed
Lecco, 23900, Italy
Completed
Badalona, 08916, Spain
Completed
Jaén, 23007, Spain
Completed
Pamplona, 31008, Spain
Completed
C/ Plató, 21, 08006, Spain
Completed
Castelló de la Plana, 12004, Spain
Completed
Burlington, L7R 4C4, Canada
Completed
Ajax, L1S 2J4, Canada
Completed
Oshawa, L1G 2B9, Canada
Completed
Bialystok, 15-276, Poland
Completed
Warszawa, 04-141, Poland
Completed
Lodz, 91-002, Poland
Completed
Warszawa, 02-637, Poland
Completed
Bologna, 40136, Italy
Completed
Abano Terme, 35031, Italy
Completed
Perugia, 06024, Italy
Completed
Parma, 43126, Italy
Completed
Firenze, 50139, Italy
Completed
Varese, 21100, Italy
Completed
Barcelona, 08036, Spain
Completed
Valencia, 46010, Spain
Completed
Barcelona, 08035, Spain
Completed
Madrid, 28040, Spain
Completed
Alcorcón, 28922, Spain
Completed
Kitchener, N2G 1G3, Canada
Completed
Peterborough, K9J 7C6, Canada
Completed
Penticton, V2A 5C8, Canada
Completed
Ottawa, K1Y 4E9, Canada
Completed
LIEGE, 4000, Belgium
Completed
ANTWERPEN, 2020, Belgium
Completed
MERKSEM, 2170, Belgium
Completed
HASSELT, 3500, Belgium
Completed
HOOFDDORP, 2134 TM, Netherlands
Completed
HILVERSUM, 1213 XZ, Netherlands
Completed
LEIDEN, 2334 CK, Netherlands
Completed
Hermosillo, 83000, Mexico
Completed
Kungälv, 442 83, Sweden
Completed
Göteborg, 416 85, Sweden
Completed
Halmstad, 301 85, Sweden
Completed
Jönköping, 551 85, Sweden
Completed
Hässleholm, 281 25, Sweden
Completed
Hellerup, DK-2900, Denmark
Completed
Windsor, N9A 1E1, Canada
Completed
Oakville, L6J 3M5, Canada
Completed
Saint John, E2L 4L2, Canada
Completed
ROESELARE, 8800, Belgium
Completed
PELLENBERG, 3212, Belgium
Completed
HASSELT, 3500, Belgium
Completed
REET, 2840, Belgium
Completed
NIJMEGEN, 6522 JV, Netherlands
Completed
Zwolle, 8011 JW, Netherlands
Completed
AMSTERDAM, Netherlands
Completed
Oss, 5342 BT, Netherlands
Completed
Guadalajara, 44280, Mexico
Completed
Chihuahua, Chih., 31000, Mexico
Completed
Varberg, 432 81, Sweden
Completed
Lidköping, 531 85, Sweden
Completed
Falköping, 521 85, Sweden
Completed
Gjövik, 2819, Norway
Completed
Kongsvinger, 2212, Norway
Completed
Worcester, 6850, South Africa
Completed
Newcastle, 2940, South Africa
Completed
Bloemfontein, 9301, South Africa
Completed
Pretoria, 0084, South Africa
Completed
Plzen, 304 60, Czech Republic
Completed
Ramat Gan, 5262000, Israel
Completed
Zerifin, 6093000, Israel
Completed
Tel Aviv, 64239, Israel
Completed
Tel Aviv, 6423906, Israel
Completed
Linz, 4010, Austria
Completed
Wien, 1140, Austria
Completed
Bogotá, Colombia
Completed
Medellín, Colombia
Completed
Shanghai, 200233, China
Completed
Silkeborg, 8600, Denmark
Completed
Hørsholm, DK-2970, Denmark
Completed
Frederiksberg, 2000, Denmark
Completed
Herlev, 2730, Denmark
Completed
Elverum, 2409, Norway
Completed
Lillehammer, 2609, Norway
Completed
Namsos, 7800, Norway
Completed
Durban, 4092, South Africa
Completed
Randburg, 2125, South Africa
Completed
Pretoria, South Africa
Completed
Somerset West, 7130, South Africa
Completed
PRETORIA, South Africa
Completed
Johannesburg, 2193, South Africa
Completed
Brno, 625 00, Czech Republic
Completed
Praha 8, 180 81, Czech Republic
Completed
Kolin, 280 00, Czech Republic
Completed
Beijing, 100044, China
Completed
Beijing, 100035, China
Completed
Callao, CALLAO 2, Peru
Completed
Callao, CALLAO 2, Peru
Completed
Pardubice, 530 03, Czech Republic
Completed
Jihlava, 586 01, Czech Republic
Completed
Havlickuv Brod, 580 01, Czech Republic
Completed
Chomutov, 430 01, Czech Republic
Completed
Kfar-Saba, 4428164, Israel
Completed
Haifa, 3109601, Israel
Completed
Holon, 58220, Israel
Completed
Beer Sheva, 8410101, Israel
Completed
Graz, 8036, Austria
Completed
Innsbruck, 6020, Austria
Completed
Cali, Colombia
Completed
Beijing, 100853, China
Completed
Shanghai, 200025, China
Completed
Shanghai, 200032, China
Completed
Lima, LIMA 1, Peru
Completed
Lima, LIMA 11, Peru
Withdrawn
Marburg, 35043, Germany
Withdrawn
Damme, 49401, Germany
Withdrawn
SAINT HERBLAIN, 44819, France
Withdrawn
BREST, 29200, France
Withdrawn
Modena, 41124, Italy
Withdrawn
Welland, L3B 4W6, Canada
Withdrawn
Guelph, N1E 4J4, Canada
Withdrawn
Red Deer, T4N 4E7, Canada
Withdrawn
Winnipeg, R3J 3M7, Canada
Withdrawn
Montreal, H3G 1A4, Canada
Withdrawn
Edmonton, T6G 2B7, Canada
Withdrawn
Stratford, N5A 2Y6, Canada
Withdrawn
Thunder Bay, P7B 6V4, Canada
Withdrawn
St. Catharines, L2R 7C6, Canada
Withdrawn
Montreal, H4J 1C5, Canada
Withdrawn
Hamilton, L9C 7N4, Canada
Withdrawn
Surrey, V3V 1Z2, Canada
Withdrawn
CHARLEROI, 6000, Belgium
Withdrawn
Mölndal, 431 80, Sweden
Withdrawn
Uddevalla, 451 80, Sweden
Withdrawn
Notodden, NO-3675, Norway
Withdrawn
Bloemfontein, 9301, South Africa
Completed
Israel
Withdrawn
Bogotá, Colombia
Withdrawn
China

Primary Outcome

  • Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
    date_rangeTime Frame:
    Treatment period: up to Day 13+/-4
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
    date_rangeTime Frame:
    Treatment period: up to Day 13+/-4
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of symptomatic VTE (DVT, PE)
    date_rangeTime Frame:
    Treatment period: up to Day 13+/-4
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of DVT (total, proximal, distal)
    date_rangeTime Frame:
    Treatment period: up to Day 13+/-4
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of symptomatic VTE during follow-up
    date_rangeTime Frame:
    Follow-up period: following 13+/-4 days
    enhanced_encryption
    Safety Issue:
    no
  • The composite endpoint comprising major VTE and treatment-emergent major bleeding
    date_rangeTime Frame:
    For major VTE, treatment period: up to Day 13+/-4 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
    date_rangeTime Frame:
    Treatment period: up to Day 13+/-4
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
    date_rangeTime Frame:
    Treatment period: up to Day 13+/-4
    enhanced_encryption
    Safety Issue:
    no
  • Treatment-emergent major bleedings
    date_rangeTime Frame:
    From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
    enhanced_encryption
    Safety Issue:
    yes

Trial design

RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a controlled., double-blind, randomized study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement.
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 results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe