The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02064439




Registration number
NCT02064439
Ethics application status
Date submitted
14/02/2014
Date registered
17/02/2014
Date last updated
19/12/2017

Titles & IDs
Public title
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Scientific 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
Secondary ID [1] 0 0
2013-000619-26
Secondary ID [2] 0 0
16416
Universal Trial Number (UTN)
Trial acronym
EinsteinChoice
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Thromboembolism 0 0
Thrombosis 0 0
Venous Thrombosis 0 0
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY 59-7939
Treatment: Drugs - BAY 59-7939
Treatment: Drugs - ASA

Experimental: Arm 1 - Rivaroxaban 10 mg once daily for 12 months

Experimental: Arm 2 - Rivaroxaban 20 mg once daily for 12 months

Active Comparator: Arm 3 - ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months


Treatment: Drugs: BAY 59-7939
10 mg tablet once daily for 12 months

Treatment: Drugs: BAY 59-7939
20 mg tablet once daily for 12 months

Treatment: Drugs: ASA
100 mg tablet once daily for 12 months

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
Timepoint [1] 0 0
Up to 12 months, at least 6 months
Primary outcome [2] 0 0
Number of Participants With First Treatment-emergent Major Bleeding
Timepoint [2] 0 0
Up to 12 months, at least 6 months
Secondary outcome [1] 0 0
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
Timepoint [1] 0 0
Up to 12 months, at least 6 months
Secondary outcome [2] 0 0
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
Timepoint [2] 0 0
Up to 12 months, at least 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Lismore
Recruitment hospital [5] 0 0
- Randwick
Recruitment hospital [6] 0 0
- St Leonards
Recruitment hospital [7] 0 0
- Westmead
Recruitment hospital [8] 0 0
- Brisbane
Recruitment hospital [9] 0 0
- Clayton
Recruitment hospital [10] 0 0
- Box Hill
Recruitment hospital [11] 0 0
- Melbourne
Recruitment hospital [12] 0 0
- Redcliffe
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4029 - Brisbane
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
4020 - Redcliffe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Austria
State/province [17] 0 0
Steiermark
Country [18] 0 0
Austria
State/province [18] 0 0
Tirol
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Belgium
State/province [20] 0 0
Aalst
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles - Brussel
Country [22] 0 0
Belgium
State/province [22] 0 0
Hasselt
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Brazil
State/province [24] 0 0
Minas Gerais
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
Country [30] 0 0
Canada
State/province [30] 0 0
New Brunswick
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
China
State/province [34] 0 0
Fujian
Country [35] 0 0
China
State/province [35] 0 0
Guangdong
Country [36] 0 0
China
State/province [36] 0 0
Guangxi
Country [37] 0 0
China
State/province [37] 0 0
Hebei
Country [38] 0 0
China
State/province [38] 0 0
Heilongjiang
Country [39] 0 0
China
State/province [39] 0 0
Hubei
Country [40] 0 0
China
State/province [40] 0 0
Hunan
Country [41] 0 0
China
State/province [41] 0 0
Jiangsu
Country [42] 0 0
China
State/province [42] 0 0
Jilin
Country [43] 0 0
China
State/province [43] 0 0
Liaoning
Country [44] 0 0
China
State/province [44] 0 0
Ningxia
Country [45] 0 0
China
State/province [45] 0 0
Shaanxi
Country [46] 0 0
China
State/province [46] 0 0
Shandong
Country [47] 0 0
China
State/province [47] 0 0
Shanxi
Country [48] 0 0
China
State/province [48] 0 0
Sichuan
Country [49] 0 0
China
State/province [49] 0 0
Yunnan
Country [50] 0 0
China
State/province [50] 0 0
Zhejiang
Country [51] 0 0
China
State/province [51] 0 0
Beijing
Country [52] 0 0
China
State/province [52] 0 0
Shanghai
Country [53] 0 0
China
State/province [53] 0 0
Tianjin
Country [54] 0 0
Czechia
State/province [54] 0 0
Kladno
Country [55] 0 0
Czechia
State/province [55] 0 0
Liberec
Country [56] 0 0
Czechia
State/province [56] 0 0
Litomysl
Country [57] 0 0
Czechia
State/province [57] 0 0
Ostrava
Country [58] 0 0
Czechia
State/province [58] 0 0
Prague
Country [59] 0 0
Czechia
State/province [59] 0 0
Praha 1
Country [60] 0 0
Czechia
State/province [60] 0 0
Praha 5
Country [61] 0 0
Czechia
State/province [61] 0 0
Usti nad Labem
Country [62] 0 0
Denmark
State/province [62] 0 0
Aarhus N
Country [63] 0 0
Denmark
State/province [63] 0 0
Copenhagen
Country [64] 0 0
Denmark
State/province [64] 0 0
Glostrup
Country [65] 0 0
Denmark
State/province [65] 0 0
Hellerup
Country [66] 0 0
Denmark
State/province [66] 0 0
Herning
Country [67] 0 0
Denmark
State/province [67] 0 0
København NV
Country [68] 0 0
Denmark
State/province [68] 0 0
Svendborg
Country [69] 0 0
France
State/province [69] 0 0
Angers
Country [70] 0 0
France
State/province [70] 0 0
Arras
Country [71] 0 0
France
State/province [71] 0 0
Besancon
Country [72] 0 0
France
State/province [72] 0 0
Bois-guillaume
Country [73] 0 0
France
State/province [73] 0 0
BREST Cedex 9
Country [74] 0 0
France
State/province [74] 0 0
Brest Cedex
Country [75] 0 0
France
State/province [75] 0 0
Castelnau Le Lez
Country [76] 0 0
France
State/province [76] 0 0
Clermont Ferrand
Country [77] 0 0
France
State/province [77] 0 0
Colombes Cedex
Country [78] 0 0
France
State/province [78] 0 0
Dijon
Country [79] 0 0
France
State/province [79] 0 0
Grenoble
Country [80] 0 0
France
State/province [80] 0 0
Le Kremlin Bicetre Cedex
Country [81] 0 0
France
State/province [81] 0 0
Le Mans
Country [82] 0 0
France
State/province [82] 0 0
Limoges Cedex
Country [83] 0 0
France
State/province [83] 0 0
Nice
Country [84] 0 0
France
State/province [84] 0 0
Paris Cedex 15
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Quimper
Country [87] 0 0
France
State/province [87] 0 0
Saint Etienne
Country [88] 0 0
France
State/province [88] 0 0
Strasbourg Cedex
Country [89] 0 0
France
State/province [89] 0 0
Toulon
Country [90] 0 0
France
State/province [90] 0 0
Toulouse
Country [91] 0 0
France
State/province [91] 0 0
Vernon
Country [92] 0 0
Germany
State/province [92] 0 0
Baden-Württemberg
Country [93] 0 0
Germany
State/province [93] 0 0
Bayern
Country [94] 0 0
Germany
State/province [94] 0 0
Hessen
Country [95] 0 0
Germany
State/province [95] 0 0
Nordrhein-Westfalen
Country [96] 0 0
Germany
State/province [96] 0 0
Rheinland-Pfalz
Country [97] 0 0
Germany
State/province [97] 0 0
Sachsen-Anhalt
Country [98] 0 0
Germany
State/province [98] 0 0
Sachsen
Country [99] 0 0
Germany
State/province [99] 0 0
Thüringen
Country [100] 0 0
Germany
State/province [100] 0 0
Berlin
Country [101] 0 0
Germany
State/province [101] 0 0
Karlsbad
Country [102] 0 0
Hungary
State/province [102] 0 0
Baja
Country [103] 0 0
Hungary
State/province [103] 0 0
Budapest
Country [104] 0 0
Hungary
State/province [104] 0 0
Debrecen
Country [105] 0 0
Hungary
State/province [105] 0 0
Gyula
Country [106] 0 0
Hungary
State/province [106] 0 0
Kecskemet
Country [107] 0 0
Hungary
State/province [107] 0 0
Miskolc
Country [108] 0 0
Hungary
State/province [108] 0 0
Pecs
Country [109] 0 0
Hungary
State/province [109] 0 0
Szentes
Country [110] 0 0
Hungary
State/province [110] 0 0
Szombathely
Country [111] 0 0
Hungary
State/province [111] 0 0
Zalaegerszeg
Country [112] 0 0
Israel
State/province [112] 0 0
Afula
Country [113] 0 0
Israel
State/province [113] 0 0
Haifa
Country [114] 0 0
Israel
State/province [114] 0 0
Holon
Country [115] 0 0
Israel
State/province [115] 0 0
Kfar Saba
Country [116] 0 0
Israel
State/province [116] 0 0
Nahariya
Country [117] 0 0
Israel
State/province [117] 0 0
Petah Tikva
Country [118] 0 0
Israel
State/province [118] 0 0
Tel-Aviv
Country [119] 0 0
Israel
State/province [119] 0 0
Zefat
Country [120] 0 0
Italy
State/province [120] 0 0
Abruzzo
Country [121] 0 0
Italy
State/province [121] 0 0
Calabria
Country [122] 0 0
Italy
State/province [122] 0 0
Emilia-Romagna
Country [123] 0 0
Italy
State/province [123] 0 0
Lombardia
Country [124] 0 0
Italy
State/province [124] 0 0
Umbria
Country [125] 0 0
Italy
State/province [125] 0 0
Veneto
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Gwangju Gwang''yeogsi
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Busan
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Daegu
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Seoul
Country [130] 0 0
Mexico
State/province [130] 0 0
Guanajuato
Country [131] 0 0
Mexico
State/province [131] 0 0
Jalisco
Country [132] 0 0
Mexico
State/province [132] 0 0
Nuevo Leon
Country [133] 0 0
Mexico
State/province [133] 0 0
Veracruz
Country [134] 0 0
Mexico
State/province [134] 0 0
Yucatán
Country [135] 0 0
Mexico
State/province [135] 0 0
Aguascalientes
Country [136] 0 0
Mexico
State/province [136] 0 0
Chihuahua
Country [137] 0 0
Netherlands
State/province [137] 0 0
Alkmaar
Country [138] 0 0
Netherlands
State/province [138] 0 0
Almere
Country [139] 0 0
Netherlands
State/province [139] 0 0
Amsterdam
Country [140] 0 0
Netherlands
State/province [140] 0 0
Assen
Country [141] 0 0
Netherlands
State/province [141] 0 0
Dordrecht
Country [142] 0 0
Netherlands
State/province [142] 0 0
Groningen
Country [143] 0 0
Netherlands
State/province [143] 0 0
Hoofddorp
Country [144] 0 0
Netherlands
State/province [144] 0 0
Maastricht
Country [145] 0 0
Netherlands
State/province [145] 0 0
Sittard
Country [146] 0 0
Netherlands
State/province [146] 0 0
Zwolle
Country [147] 0 0
New Zealand
State/province [147] 0 0
Auckland
Country [148] 0 0
New Zealand
State/province [148] 0 0
Christchurch
Country [149] 0 0
New Zealand
State/province [149] 0 0
Palmerston North
Country [150] 0 0
New Zealand
State/province [150] 0 0
Wellington
Country [151] 0 0
Norway
State/province [151] 0 0
Fredrikstad
Country [152] 0 0
Norway
State/province [152] 0 0
Oslo
Country [153] 0 0
Philippines
State/province [153] 0 0
Quezon City
Country [154] 0 0
Poland
State/province [154] 0 0
Bialystok
Country [155] 0 0
Poland
State/province [155] 0 0
Bydgoszcz
Country [156] 0 0
Poland
State/province [156] 0 0
Poznan
Country [157] 0 0
Poland
State/province [157] 0 0
Warszawa
Country [158] 0 0
Poland
State/province [158] 0 0
Wroclaw
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Barnaul
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Moscow
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Novosibirsk
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Rostov-on-Don
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Ryazan
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Sochi
Country [165] 0 0
Russian Federation
State/province [165] 0 0
St. Petersburg
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Tver
Country [167] 0 0
South Africa
State/province [167] 0 0
Gauteng
Country [168] 0 0
South Africa
State/province [168] 0 0
Western Cape
Country [169] 0 0
South Africa
State/province [169] 0 0
Bloemfontein
Country [170] 0 0
Spain
State/province [170] 0 0
Alicante
Country [171] 0 0
Spain
State/province [171] 0 0
Barcelona
Country [172] 0 0
Spain
State/province [172] 0 0
Madrid
Country [173] 0 0
Spain
State/province [173] 0 0
Girona
Country [174] 0 0
Sweden
State/province [174] 0 0
Göteborg
Country [175] 0 0
Sweden
State/province [175] 0 0
Kristianstad
Country [176] 0 0
Switzerland
State/province [176] 0 0
Basel-Stadt
Country [177] 0 0
Switzerland
State/province [177] 0 0
Vaud
Country [178] 0 0
Switzerland
State/province [178] 0 0
Bern
Country [179] 0 0
Switzerland
State/province [179] 0 0
Fribourg
Country [180] 0 0
Switzerland
State/province [180] 0 0
Genève
Country [181] 0 0
Switzerland
State/province [181] 0 0
Luzern
Country [182] 0 0
Taiwan
State/province [182] 0 0
New Taipei City
Country [183] 0 0
Taiwan
State/province [183] 0 0
Taichung
Country [184] 0 0
Taiwan
State/province [184] 0 0
Taipei
Country [185] 0 0
Thailand
State/province [185] 0 0
Bangkok
Country [186] 0 0
Thailand
State/province [186] 0 0
Khon Kaen
Country [187] 0 0
Turkey
State/province [187] 0 0
Istanbul
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Devon
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Humberside
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Tyne And Wear
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Cardiff
Country [192] 0 0
United Kingdom
State/province [192] 0 0
London
Country [193] 0 0
Vietnam
State/province [193] 0 0
Ha Noi
Country [194] 0 0
Vietnam
State/province [194] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Scientific Affairs, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT02064439
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02064439