Clinical trial NCT00362232: Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
Official title: RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Prevention of venous thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 3148
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 BAY59-7939, 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 Low Molecular Weight Heparin (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 Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population
timeFrame: Up to 16 days after surgery
measure: Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.
timeFrame: Up to 16 days after surgery
Secondary outcomes:
measure: Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE
timeFrame: Up to 16 days after surgery
measure: Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.
timeFrame: Up to 16 days after surgery
measure: Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of DVT (Proximal, Distal) Per Protocol Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of Symptomatic VTE During Follow-up Per Protocol Population.
timeFrame: Up to 47 days after surgery
measure: Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.
timeFrame: Up to 47 days after surgery
measure: The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit
timeFrame: Up to 47 days after surgery
measure: Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.
timeFrame: Up to 16 days after surgery
measure: Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.
timeFrame: Up to 16 days after surgery
measure: Treatment-emergent Major Bleedings Per Safety Population.
timeFrame: from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Torrance
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Towson
country: United States
state: Maryland
city: Missoula
country: United States
state: Montana
city: Teaneck
country: United States
state: New Jersey
city: Greensboro
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Johnstown
country: United States
state: Pennsylvania
city: State College
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Red Deer
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: Fredericton
country: Canada
state: New Brunswick
city: Ajax
country: Canada
state: Ontario
city: Brantford
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: Scarborough
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Woodstock
country: Canada
state: Ontario
city: Charlottetown
country: Canada
state: Prince Edward Island
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Hellerup
country: Denmark
city: Herlev
country: Denmark
city: Hvidovre
country: Denmark
city: Hørsholm
country: Denmark
city: Silkeborg
country: Denmark
city: Viborg
country: Denmark
city: Hyderabad
country: India
state: Andhra Pradesh
city: Secunderabad
country: India
state: Andhra Pradesh
city: Secundrabad
country: India
state: Andhra Pradesh
city: Ahmedabad
country: India
state: Gujarat
city: Ahmedabad
country: India
state: Gujarat
city: Pune
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Ludhiana
country: India
state: Punjab
city: Chennai
country: India
state: Tamil Nadu
city: Bangalore
country: India
city: Bangalore
country: India
city: Baroda
country: India
city: Hyderabad
country: India
city: New Delhi
country: India
city: Beer Sheva
country: Israel
city: Holon
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Panevezys
country: Lithuania
city: Vilnius
country: Lithuania
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Zapopan
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Mérida
country: Mexico
state: Yucatán
city: Edo. de Mexico
country: Mexico
city: Baerum postterminal
country: Norway
city: Gjövik
country: Norway
city: Kongsvinger
country: Norway
city: Lillehammer
country: Norway
city: Karachi
country: Pakistan
state: Sindh
city: Karachi
country: Pakistan
state: Sindh
city: Bydgoszcz
country: Poland
city: Elblag
country: Poland
city: Gdansk
country: Poland
city: Kielce
country: Poland
city: Konskie
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Sosnowiec
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Colombo-80
country: Sri Lanka
city: Kotte
country: Sri Lanka
city: Ragama
country: Sri Lanka
city: Göteborg
country: Sweden
city: Hässleholm
country: Sweden
city: Stockholm
country: Sweden
city: Västervik
country: Sweden
city: Växjö
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.