Clinical trial NCT02064439: Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Official title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Keywords: deep vein thrombosis
pulmonary embolism
long-term prevention of recurrent symptomatic VTE
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2014-02-17
Enrollment: 3365
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: This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week

Exclusion Criteria:

* Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min

Primary outcomes:
measure: Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
timeFrame: Up to 12 months, at least 6 months
measure: Number of Participants With First Treatment-emergent Major Bleeding
timeFrame: Up to 12 months, at least 6 months
Secondary outcomes:
measure: Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
timeFrame: Up to 12 months, at least 6 months
measure: Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
timeFrame: Up to 12 months, at least 6 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Ventura
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Joliet
country: United States
state: Illinois
city: Rockport
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Raleigh
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Fredericksburg
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Garran
country: Australia
state: Australian Capital Territory
city: Concord
country: Australia
state: New South Wales
city: Kogarah
country: Australia
state: New South Wales
city: Lismore
country: Australia
state: New South Wales
city: Randwick
country: Australia
state: New South Wales
city: St Leonards
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Box Hill
country: Australia
city: Melbourne
country: Australia
city: Redcliffe
country: Australia
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Porto Alegre
country: Brazil
state: Rio Grande Do Sul
city: Campinas
country: Brazil
state: Sao Paulo
city: Santo André
country: Brazil
state: Sao Paulo
city: Santo André
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Saint John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: St. Jerome
country: Canada
state: Quebec
city: Fuzhou
country: China
state: Fujian
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Nanning
country: China
state: Guangxi
city: Shijiazhuang
country: China
state: Hebei
city: Harbin
country: China
state: Heilongjiang
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Changsha
country: China
state: Hunan
city: Nantong
country: China
state: Jiangsu
city: Suzhou
country: China
state: Jiangsu
city: Changchun
country: China
state: Jilin
city: Shengyang
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Yinchuan
country: China
state: Ningxia
city: Xi'an
country: China
state: Shaanxi
city: Xi'an
country: China
state: Shaanxi
city: Jinan
country: China
state: Shandong
city: Qingdao
country: China
state: Shandong
city: Taiyuan
country: China
state: Shanxi
city: Chengdu
country: China
state: Sichuan
city: Kunming
country: China
state: Yunnan
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Wenzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
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: Shanghai
country: China
city: Tianjin
country: China
city: Tianjin
country: China
city: Tianjin
country: China
city: Kladno
country: Czechia
city: Liberec
country: Czechia
city: Litomysl
country: Czechia
city: Ostrava
country: Czechia
city: Ostrava
country: Czechia
city: Prague
country: Czechia
city: Praha 1
country: Czechia
city: Praha 5
country: Czechia
city: Usti nad Labem
country: Czechia
city: Aarhus N
country: Denmark
city: Copenhagen
country: Denmark
city: Glostrup
country: Denmark
city: Hellerup
country: Denmark
city: Herning
country: Denmark
city: København NV
country: Denmark
city: Svendborg
country: Denmark
city: Angers
country: France
city: Arras
country: France
city: Besancon
country: France
city: Bois-guillaume
country: France
city: BREST Cedex 9
country: France
city: Brest Cedex
country: France
city: Castelnau Le Lez
country: France
city: Clermont Ferrand
country: France
city: Colombes Cedex
country: France
city: Dijon
country: France
city: Grenoble
country: France
city: Le Kremlin Bicetre Cedex
country: France
city: Le Mans
country: France
city: Limoges Cedex
country: France
city: Nice
country: France
city: Paris Cedex 15
country: France
city: Paris
country: France
city: Paris
country: France
city: Quimper
country: France
city: Saint Etienne
country: France
city: Strasbourg Cedex
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Vernon
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Witten
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Erfurt
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Karlsbad
country: Germany
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Szentes
country: Hungary
city: Szombathely
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Afula
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Kfar Saba
country: Israel
city: Nahariya
country: Israel
city: Petah Tikva
country: Israel
city: Tel-Aviv
country: Israel
city: Zefat
country: Israel
city: Chieti
country: Italy
state: Abruzzo
city: Cosenza
country: Italy
state: Calabria
city: Piacenza
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Varese
country: Italy
state: Lombardia
city: Perugia
country: Italy
state: Umbria
city: Padova
country: Italy
state: Veneto
city: Treviso
country: Italy
state: Veneto
city: Treviso
country: Italy
state: Veneto
city: Donggu,
country: Korea, Republic of
state: Gwangju Gwang''yeogsi
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Leon
country: Mexico
state: Guanajuato
city: León
country: Mexico
state: Guanajuato
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Xalapa
country: Mexico
state: Veracruz
city: Merida
country: Mexico
state: Yucatán
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Alkmaar
country: Netherlands
city: Almere
country: Netherlands
city: Amsterdam
country: Netherlands
city: Assen
country: Netherlands
city: Dordrecht
country: Netherlands
city: Groningen
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Maastricht
country: Netherlands
city: Sittard
country: Netherlands
city: Zwolle
country: Netherlands
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Palmerston North
country: New Zealand
city: Wellington
country: New Zealand
city: Fredrikstad
country: Norway
city: Oslo
country: Norway
city: Quezon City
country: Philippines
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Barnaul
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Sochi
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tver
country: Russian Federation
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria West
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Roodepoort
country: South Africa
state: Gauteng
city: Worcester
country: South Africa
state: Western Cape
city: Bloemfontein
country: South Africa
city: Torrevieja
country: Spain
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: San Sebastián de los Reyes
country: Spain
state: Madrid
city: Girona
country: Spain
city: Madrid
country: Spain
city: Göteborg
country: Sweden
city: Kristianstad
country: Sweden
city: Basel
country: Switzerland
state: Basel-Stadt
city: Lausanne
country: Switzerland
state: Vaud
city: Bern
country: Switzerland
city: Fribourg
country: Switzerland
city: Genève
country: Switzerland
city: Luzern
country: Switzerland
city: New Taipei City
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Plymouth
country: United Kingdom
state: Devon
city: Hull
country: United Kingdom
state: Humberside
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Cardiff
country: United Kingdom
city: London
country: United Kingdom
city: Ha Noi
country: Vietnam
city: Ho Chi Minh
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.
citation: Flumignan CD, Nakano LC, Baptista-Silva JC, Flumignan RL. Antiplatelet agents for the treatment of deep venous thrombosis. Cochrane Database Syst Rev. 2022 Jul 25;7(7):CD012369. doi: 10.1002/14651858.CD012369.pub2.
citation: Weitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Freitas MCS, Holberg G, Kakkar AK, Haskell L, van Bellen B, Pap AF, Berkowitz SD, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017 Mar 30;376(13):1211-1222. doi: 10.1056/NEJMoa1700518. Epub 2017 Mar 18.