Clinical trial NCT00332020: Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
Official title: RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention
Venous Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 2457
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 can help prevent blood clots forming after a hip replacement operation.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 years or above
* Patients scheduled for elective total hip replacement

Exclusion Criteria:

* Planned, staged total bilateral hip replacement
* Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
* Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
* Conditions prohibiting bilateral venography (e.g. amputation of one 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 35+/-6
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 35+/-6
measure: Incidence of symptomatic VTE (DVT, PE)
timeFrame: Treatment period: up to day 35+/-6
measure: Incidence of DVT (total, proximal, distal)
timeFrame: Treatment period: up to day 35+/-6
measure: Incidence of symptomatic VTE during follow-up
timeFrame: Follow-up period: following 35+/-6 days
measure: The composite endpoint comprising major VTE and treatment-emergent major bleeding
timeFrame: For major VTE, treatment period: up to Day 35+/-6 ; 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 35+/-6
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 35+/-6
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: Birmingham
country: United States
state: Alabama
city: Denver
country: United States
state: Colorado
city: Bay Pines
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Oklahoma City
country: United States
state: Oklahoma
city: Canberra
country: Australia
state: Australian Capital Territory
city: Lismore
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Southport
country: Australia
state: Queensland
city: Geelong
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Curitiba
country: Brazil
state: Paraná
city: Passo Fundo
country: Brazil
state: Rio Grande do Sul
city: Batatais
country: Brazil
state: Sao Paulo
city: Marília
country: Brazil
state: Sao Paulo
city: Sao Paulo
country: Brazil
state: SP
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Red Deer
country: Canada
state: Alberta
city: Penticton
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. John
country: Canada
state: New Brunswick
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Guangzhou,
country: China
state: Guangdong
city: Jinan
country: China
state: Shandong
city: Qingdao
country: China
state: Shandong
city: Xi'an
country: China
state: Shanxi
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: Shanghai
country: China
city: Barranquilla
country: Colombia
city: Bogotá
country: Colombia
city: Cali
country: Colombia
city: Medellín
country: Colombia
city: Copenhagen
country: Denmark
city: Copenhagen
country: Denmark
city: Frederiksberg
country: Denmark
city: Glostrup
country: Denmark
city: Herlev
country: Denmark
city: Holbaek
country: Denmark
city: Hvidovre
country: Denmark
city: Silkeborg
country: Denmark
city: Viborg
country: Denmark
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Hyderabad
country: India
state: Andhra Pradesh
city: Secundrabad
country: India
state: Andra Pradesh
city: Ludhiana
country: India
state: Punjab
city: Bangalore
country: India
city: Bangalore
country: India
city: Mumbai
country: India
city: Bandung
country: Indonesia
state: West Java
city: Surabaya
country: Indonesia
city: Genova
country: Italy
city: Lecco
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Parma
country: Italy
city: Siena
country: Italy
city: Udine
country: Italy
city: Daegu
country: Korea, Republic of
city: Kyunggido
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Panevezys
country: Lithuania
city: Siauliai
country: Lithuania
city: Chihuahua, Chih.
country: Mexico
state: Chihuahua
city: Guadalajara
country: Mexico
state: Jalisco
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Kongsvinger
country: Norway
city: Namsos
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Tynset
country: Norway
city: Callao
country: Peru
city: Lima Cercado
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Setúbal
country: Portugal
city: Torres Vedras
country: Portugal
city: Bloemfontein
country: South Africa
state: Freestate
city: Johannesburg
country: South Africa
state: Gauteng
city: Randburg
country: South Africa
state: Gauteng
city: Newcastle
country: South Africa
state: Kwa Zulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Falköping
country: Sweden
city: Hässleholm
country: Sweden
city: Kungälv
country: Sweden
city: Lidköping
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Varberg
country: Sweden
city: Växjö
country: Sweden
city: Örebro
country: Sweden
city: Kaohsiung
country: Taiwan
city: Taoyuan
country: Taiwan
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Dumfries
country: United Kingdom
state: Dumfries and Galloway
city: Kirkcaldy
country: United Kingdom
state: Fife
city: London
country: United Kingdom
state: Greater London
city: Liverpool
country: United Kingdom
state: Merseyside
city: Great Yarmouth
country: United Kingdom
state: Norfolk
city: Northampton
country: United Kingdom
state: Northamptonshire
city: Epsom
country: United Kingdom
state: Surrey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008 Jul 5;372(9632):31-9. doi: 10.1016/S0140-6736(08)60880-6. Epub 2008 Jun 24.