Clinical trial NCT00361894: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention
Venous Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 2531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
timeFrame: Treatment period: up to Day 13+/-4
Secondary outcomes:
measure: 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
measure: Incidence of symptomatic VTE (DVT, PE)
timeFrame: Treatment period: up to Day 13+/-4
measure: Incidence of DVT (total, proximal, distal)
timeFrame: Treatment period: up to Day 13+/-4
measure: Incidence of symptomatic VTE during follow-up
timeFrame: Follow-up period: following 13+/-4 days
measure: The composite endpoint comprising major VTE and treatment-emergent major bleeding
timeFrame: 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
measure: Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
timeFrame: Treatment period: up to Day 13+/-4
measure: Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
timeFrame: Treatment period: up to Day 13+/-4
measure: Treatment-emergent major bleedings
timeFrame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Other outcomes:
Locations:
city: Linz
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Hasselt
country: Belgium
city: Liege
country: Belgium
city: Merksem
country: Belgium
city: Pellenberg
country: Belgium
city: Reet
country: Belgium
city: Roeselare
country: Belgium
city: Penticton
country: Canada
state: British Columbia
city: St. John
country: Canada
state: New Brunswick
city: Burlington
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Bogotá
country: Colombia
city: Cali
country: Colombia
city: Medellín
country: Colombia
city: Praha 8
country: Czech Republic
state: Tschechien
city: Brno
country: Czech Republic
city: Chomutov
country: Czech Republic
city: Havlickuv Brod
country: Czech Republic
city: Jihlava
country: Czech Republic
city: Kolin
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Plzen
country: Czech Republic
city: Frederiksberg
country: Denmark
city: Hellerup
country: Denmark
city: Herlev
country: Denmark
city: Hørsholm
country: Denmark
city: Silkeborg
country: Denmark
city: Bois-guillaume
country: France
city: Clermont Ferrand
country: France
city: Lievin
country: France
city: Marseille
country: France
city: Monaco
country: France
city: Nantes Cedex 2
country: France
city: Nice
country: France
city: Nice
country: France
city: Paris Cedex 14
country: France
city: Paris Cedex 19
country: France
city: Paris Cedex 20
country: France
city: Paris
country: France
city: Soyaux
country: France
city: Vandoeuvre Les Nancy
country: France
city: Bad Mergentheim
country: Germany
state: Baden-Württemberg
city: Rheinfelden
country: Germany
state: Baden-Württemberg
city: Fürth
country: Germany
state: Bayern
city: Garmisch-Partenkirchen
country: Germany
state: Bayern
city: Würzburg
country: Germany
state: Bayern
city: Sommerfeld
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Witten
country: Germany
state: Nordrhein-Westfalen
city: Bremen
country: Germany
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Kfar Saba
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Zerifin
country: Israel
city: San Donato Milanese
country: Italy
state: Milano
city: Abano Terme
country: Italy
state: Padova
city: Gubbio
country: Italy
state: Perugia
city: Alghero
country: Italy
state: Sassari
city: Bologna
country: Italy
city: Firenze
country: Italy
city: Lecco
country: Italy
city: Padova
country: Italy
city: Parma
country: Italy
city: Roma
country: Italy
city: Udine
country: Italy
city: Varese
country: Italy
city: Chihuahua, Chih.
country: Mexico
state: Chihuahua
city: Guadalajara
country: Mexico
state: Jalisco
city: Hermosillo
country: Mexico
state: Sonora
city: Amsterdam
country: Netherlands
city: Hilversum
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Leiden
country: Netherlands
city: Nijmegen
country: Netherlands
city: OSS
country: Netherlands
city: Zwolle
country: Netherlands
city: Elverum
country: Norway
city: Gjövik
country: Norway
city: Kongsvinger
country: Norway
city: Lillehammer
country: Norway
city: Namsos
country: Norway
city: Callao
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Bloemfontein
country: South Africa
state: Freestate
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Randburg
country: South Africa
state: Gauteng
city: Newcastle
country: South Africa
state: Kwa Zulu-Natal
city: Durban
country: South Africa
state: KwaZulu Natal
city: Somerset West
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Badalona
country: Spain
state: Barcelona
city: Alcorcón
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Castellón de la Plana
country: Spain
city: Jaén
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
city: Falköping
country: Sweden
city: Göteborg
country: Sweden
city: Halmstad
country: Sweden
city: Hässleholm
country: Sweden
city: Jönköping
country: Sweden
city: Kungälv
country: Sweden
city: Lidköping
country: Sweden
city: Varberg
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.