Trial Condition(s):
Prevention, Venous Thromboembolism
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. (RECORD 3)
Bayer Identifier:
11356
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Frankurt am Main, Germany, 60528 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rheinfelden, Germany, 79618 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Witten, Germany, 58455 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Mergentheim, Germany, 97980 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 19, France, 75019 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEVIN, France, 62806 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BOIS-GUILLAUME, France, 76230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONACO, France, 98000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SOYAUX, France, 16800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bydgoszcz, Poland, 85-094 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdansk, Poland, 80-803 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-826 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fürth, Germany, 90766 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 65929 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Garmisch-Partenkirchen, Germany, 82467 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sommerfeld, Germany, 16766 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bremen, Germany, 28177 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 14, France, 75877 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STRASBOURG, France, 67098 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES CEDEX, France, 44277 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT FERRAND, France, 63050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 20, France, 75960 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 71-252 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-718 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alghero, Italy, 07041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Udine, Italy, 33100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lecco, Italy, 23900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jaén, Spain, 23007 | 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 C/ Plató, 21, Spain, 08006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Castelló de la Plana, Spain, 12004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, Canada, L7R 4C4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ajax, Canada, L1S 2J4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oshawa, Canada, L1G 2B9 | 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 Warszawa, Poland, 04-141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 91-002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-637 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40136 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Abano Terme, Italy, 35031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06024 | 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 Firenze, Italy, 50139 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varese, Italy, 21100 | 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 Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alcorcón, Spain, 28922 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitchener, Canada, N2G 1G3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Peterborough, Canada, K9J 7C6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Penticton, Canada, V2A 5C8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1Y 4E9 | 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 ANTWERPEN, Belgium, 2020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MERKSEM, Belgium, 2170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HASSELT, Belgium, 3500 | 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 HILVERSUM, Netherlands, 1213 XZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEIDEN, Netherlands, 2334 CK | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hermosillo, Mexico, 83000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kungälv, Sweden, 442 83 | 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 Halmstad, Sweden, 301 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 Hässleholm, Sweden, 281 25 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hellerup, Denmark, DK-2900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Windsor, Canada, N9A 1E1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oakville, Canada, L6J 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saint John, Canada, E2L 4L2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROESELARE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PELLENBERG, Belgium, 3212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site REET, Belgium, 2840 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6522 JV | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zwolle, Netherlands, 8011 JW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oss, Netherlands, 5342 BT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Mexico, 44280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chihuahua, Chih., Mexico, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varberg, Sweden, 432 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lidköping, Sweden, 531 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Falköping, Sweden, 521 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gjövik, Norway, 2819 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kongsvinger, Norway, 2212 | 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 Newcastle, South Africa, 2940 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bloemfontein, South Africa, 9301 | 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 Plzen, Czech Republic, 304 60 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zerifin, Israel, 6093000 | Status Completed | 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 Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4010 | 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 Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Silkeborg, Denmark, 8600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hørsholm, Denmark, DK-2970 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frederiksberg, Denmark, 2000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herlev, Denmark, 2730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elverum, Norway, 2409 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lillehammer, Norway, 2609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Namsos, Norway, 7800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Randburg, South Africa, 2125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa | Status Completed | Contact Us: E-mail: [email protected] 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 PRETORIA, South Africa | 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 Brno, Czech Republic, 625 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 8, Czech Republic, 180 81 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kolin, Czech Republic, 280 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Callao, Peru, CALLAO 2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pardubice, Czech Republic, 530 03 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jihlava, Czech Republic, 586 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Havlickuv Brod, Czech Republic, 580 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chomutov, Czech Republic, 430 01 | 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 Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holon, Israel, 58220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Status Completed | Contact Us: E-mail: [email protected]thcare.com Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | 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 |
Locations Investigative Site Cali, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100853 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200025 | 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 Lima, Peru, LIMA 1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lima, Peru, LIMA 11 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causesTimeframe: Treatment period: up to Day 13+/-4
Secondary Outcome
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)Timeframe: Treatment period: up to Day 13+/-4
- Incidence of symptomatic VTE (DVT, PE)Timeframe: Treatment period: up to Day 13+/-4
- Incidence of DVT (total, proximal, distal)Timeframe: Treatment period: up to Day 13+/-4
- Incidence of symptomatic VTE during follow-upTimeframe: Follow-up period: following 13+/-4 days
- The composite endpoint comprising major VTE and treatment-emergent major bleedingTimeframe: 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
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all deathTimeframe: Treatment period: up to Day 13+/-4
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related deathTimeframe: Treatment period: up to Day 13+/-4
- Treatment-emergent major bleedingsTimeframe: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Additional Information
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