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Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism) (EinsteinChoice)

Primary Purpose

Pulmonary Embolism, Thromboembolism, Thrombosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BAY 59-7939
BAY 59-7939
ASA
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Embolism focused on measuring deep vein thrombosis, pulmonary embolism, long-term prevention of recurrent symptomatic VTE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Rivaroxaban 10 mg once daily for 12 months

Rivaroxaban 20 mg once daily for 12 months

ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months

Outcomes

Primary Outcome Measures

Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Number of Participants With First Treatment-emergent Major Bleeding
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Secondary Outcome Measures

Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.

Full Information

First Posted
February 14, 2014
Last Updated
December 17, 2017
Sponsor
Bayer
Collaborators
Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02064439
Brief Title
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Acronym
EinsteinChoice
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 5, 2014 (Actual)
Primary Completion Date
September 22, 2016 (Actual)
Study Completion Date
November 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Thromboembolism, Thrombosis, Venous Thrombosis, Venous Thromboembolism
Keywords
deep vein thrombosis, pulmonary embolism, long-term prevention of recurrent symptomatic VTE

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Rivaroxaban 10 mg once daily for 12 months
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Rivaroxaban 20 mg once daily for 12 months
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
BAY 59-7939
Intervention Description
10 mg tablet once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
BAY 59-7939
Intervention Description
20 mg tablet once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
ASA
Intervention Description
100 mg tablet once daily for 12 months
Primary Outcome Measure Information:
Title
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
Description
The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time Frame
Up to 12 months, at least 6 months
Title
Number of Participants With First Treatment-emergent Major Bleeding
Description
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time Frame
Up to 12 months, at least 6 months
Secondary Outcome Measure Information:
Title
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
Description
The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time Frame
Up to 12 months, at least 6 months
Title
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
Description
The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
Time Frame
Up to 12 months, at least 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
City
Rockport
State/Province
Maine
ZIP/Postal Code
04856
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-2433
Country
United States
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
City
Redcliffe
ZIP/Postal Code
4020
Country
Australia
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-970
Country
Brazil
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09190-615
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
City
St. Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
City
Harbin
State/Province
Heilongjiang
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430032
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
City
Beijing
ZIP/Postal Code
100020
Country
China
City
Beijing
ZIP/Postal Code
100029
Country
China
City
Beijing
ZIP/Postal Code
100037
Country
China
City
Beijing
ZIP/Postal Code
100053
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200233
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Tianjin
ZIP/Postal Code
300052
Country
China
City
Tianjin
ZIP/Postal Code
300121
Country
China
City
Tianjin
ZIP/Postal Code
300211
Country
China
City
Kladno
ZIP/Postal Code
27259
Country
Czechia
City
Liberec
ZIP/Postal Code
46063
Country
Czechia
City
Litomysl
ZIP/Postal Code
570 14
Country
Czechia
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
City
Prague
ZIP/Postal Code
118 33
Country
Czechia
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
City
Herning
ZIP/Postal Code
7400
Country
Denmark
City
København NV
ZIP/Postal Code
2400
Country
Denmark
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
City
Angers
ZIP/Postal Code
49933
Country
France
City
Arras
ZIP/Postal Code
62000
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bois-guillaume
ZIP/Postal Code
76320
Country
France
City
BREST Cedex 9
ZIP/Postal Code
29240
Country
France
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
City
Castelnau Le Lez
ZIP/Postal Code
34170
Country
France
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
City
Colombes Cedex
ZIP/Postal Code
92701
Country
France
City
Dijon
ZIP/Postal Code
21000
Country
France
City
Grenoble
ZIP/Postal Code
38043
Country
France
City
Le Kremlin Bicetre Cedex
ZIP/Postal Code
94275
Country
France
City
Le Mans
ZIP/Postal Code
72037
Country
France
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
City
Nice
ZIP/Postal Code
06002
Country
France
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Quimper
ZIP/Postal Code
29000
Country
France
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
City
Toulon
ZIP/Postal Code
83056
Country
France
City
Toulouse
ZIP/Postal Code
31403
Country
France
City
Vernon
ZIP/Postal Code
27200
Country
France
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58448
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
City
Berlin
ZIP/Postal Code
10787
Country
Germany
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
City
Baja
ZIP/Postal Code
6500
Country
Hungary
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Afula
ZIP/Postal Code
1834111
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
City
Holon
ZIP/Postal Code
5810001
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
City
Cosenza
State/Province
Calabria
ZIP/Postal Code
87100
Country
Italy
City
Piacenza
State/Province
Emilia-Romagna
ZIP/Postal Code
29121
Country
Italy
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
City
Varese
State/Province
Lombardia
ZIP/Postal Code
21100
Country
Italy
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31029
Country
Italy
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31033
Country
Italy
City
Donggu,
State/Province
Gwangju Gwang''yeogsi
ZIP/Postal Code
501-757
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91020
Country
Mexico
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97129
Country
Mexico
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Assen
ZIP/Postal Code
9401 RK
Country
Netherlands
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Sittard
ZIP/Postal Code
6131 BK
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Auckland
ZIP/Postal Code
1309
Country
New Zealand
City
Auckland
ZIP/Postal Code
2024
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
City
Fredrikstad
ZIP/Postal Code
1603
Country
Norway
City
Oslo
ZIP/Postal Code
0450
Country
Norway
City
Quezon City
ZIP/Postal Code
NCR 1100
Country
Philippines
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
City
Poznan
ZIP/Postal Code
60-631
Country
Poland
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2132
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2191
Country
South Africa
City
Pretoria West
State/Province
Gauteng
ZIP/Postal Code
0082
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
City
Roodepoort
State/Province
Gauteng
ZIP/Postal Code
1724
Country
South Africa
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
City
Kristianstad
ZIP/Postal Code
29185
Country
Sweden
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Fribourg
ZIP/Postal Code
1700
Country
Switzerland
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
Istanbul
ZIP/Postal Code
34-300
Country
Turkey
City
Istanbul
ZIP/Postal Code
34760
Country
Turkey
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Hull
State/Province
Humberside
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
City
Ha Noi
Country
Vietnam
City
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
25994838
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.
Results Reference
background
PubMed Identifier
35876829
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.
Results Reference
derived
PubMed Identifier
28316279
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.
Results Reference
derived

Learn more about this trial

Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

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