Back to resultsOral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban (Xarelto, BAY59-7939)
Enoxaparin overlapping with and followed by VKA
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria:
- Confirmed acute symptomatic proximal PE with or without symptomatic DVT
Exclusion Criteria:
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
- Other indication for VKA than DVT and/or PE
- The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rivaroxaban (Xarelto, BAY59-7939)
Enoxaparin/VKA
Arm Description
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
Outcomes
Primary Outcome Measures
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Secondary Outcome Measures
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
Percentage of Participants With All Deaths
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
Full Information
NCT ID
NCT00439777
First Posted
February 23, 2007
Last Updated
January 25, 2014
Sponsor
Bayer
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00439777
Brief Title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Official Title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).
Detailed Description
Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4833 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivaroxaban (Xarelto, BAY59-7939)
Arm Type
Experimental
Arm Description
Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
Arm Title
Enoxaparin/VKA
Arm Type
Active Comparator
Arm Description
Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin overlapping with and followed by VKA
Intervention Description
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
Primary Outcome Measure Information:
Title
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Time Frame
3-, 6-, or 12-month study treatment period
Secondary Outcome Measure Information:
Title
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Time Frame
3-, 6-, or 12-month study treatment period
Title
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
Description
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Time Frame
3-, 6-, or 12-month study treatment period
Title
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Time Frame
3-, 6- or 12-month study treatment period
Title
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Time Frame
3-, 6- or 12-month study treatment period
Title
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
Time Frame
3-, 6- or 12-month study treatment period
Title
Percentage of Participants With All Deaths
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
Time Frame
3-, 6- or 12-month study treatment period
Title
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
Description
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
Time Frame
3-, 6- or 12-month study treatment period
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
Time Frame
3-, 6- or 12-month study treatment period
Title
Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
Time Frame
Up to 30 days after the last intake of study medication
Title
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
Time Frame
Up to 30 days after the last intake of study medication
Title
Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
Description
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
Time Frame
Up to 30 days after the last intake of study medication
Title
Percentage of Participants With Recurrent DVT During Observational Period
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
Time Frame
Up to 30 days after the last intake of study medication
Title
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Description
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.
Time Frame
Up to 30 days after the last intake of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed acute symptomatic proximal PE with or without symptomatic DVT
Exclusion Criteria:
Legal lower age limitations (country specific)
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
Other indication for VKA than DVT and/or PE
The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1096
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7035
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Escaldes - Engordany
Country
Andorra
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
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
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2229
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Redcliffe
State/Province
Queensland
ZIP/Postal Code
4020
Country
Australia
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4010
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1140
Country
Austria
City
Wien
ZIP/Postal Code
1171
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
Duffel
ZIP/Postal Code
2570
Country
Belgium
City
Genk
ZIP/Postal Code
3600
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Lier
ZIP/Postal Code
2500
Country
Belgium
City
Namur
ZIP/Postal Code
5000
Country
Belgium
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
City
Zottegem
ZIP/Postal Code
9620
Country
Belgium
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80050-350
Country
Brazil
City
Londrina
State/Province
Parana
ZIP/Postal Code
86038440
Country
Brazil
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618 000
Country
Brazil
City
Sorocaba
State/Province
Sao Paulo
ZIP/Postal Code
18031-000
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
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Guangzhou
State/Province
Guangdong
Country
China
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
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
100038
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Kladno
ZIP/Postal Code
27259
Country
Czech Republic
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
728 80
Country
Czech Republic
City
Prague 5
ZIP/Postal Code
150 00
Country
Czech Republic
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
City
Praha 2
ZIP/Postal Code
12800
Country
Czech Republic
City
Rakovnik
ZIP/Postal Code
269 01
Country
Czech Republic
City
Usti nad Lebem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
City
Braedstrup
ZIP/Postal Code
8740
Country
Denmark
City
Frederiksberg
ZIP/Postal Code
2000F
Country
Denmark
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Agen Cedex 9
ZIP/Postal Code
47923
Country
France
City
Amiens
ZIP/Postal Code
80000
Country
France
City
Angers Cedex 01
ZIP/Postal Code
49033
Country
France
City
Arras
ZIP/Postal Code
62000
Country
France
City
Besancon
ZIP/Postal Code
25000
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
City
Castelnau Le Lez
ZIP/Postal Code
34170
Country
France
City
Clamart
ZIP/Postal Code
92141
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
Limoges
ZIP/Postal Code
87042
Country
France
City
Metz-tessy
ZIP/Postal Code
74370
Country
France
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
City
Nantes
ZIP/Postal Code
44000
Country
France
City
Nice
ZIP/Postal Code
06002
Country
France
City
Orthez
ZIP/Postal Code
64300
Country
France
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
City
Paris
ZIP/Postal Code
75004
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75877
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Roanne
ZIP/Postal Code
42328
Country
France
City
Rouen Cedex
ZIP/Postal Code
76031
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
83000
Country
France
City
Toulouse
ZIP/Postal Code
31403
Country
France
City
Valenciennes Cedex
ZIP/Postal Code
59322
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Vernon
ZIP/Postal Code
27200
Country
France
City
Bruchsal
State/Province
Baden-Württemberg
ZIP/Postal Code
76646
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Karlsbad
State/Province
Baden-Württemberg
ZIP/Postal Code
76307
Country
Germany
City
Neckargemünd
State/Province
Baden-Württemberg
ZIP/Postal Code
69151
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80331
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Rotenburg
State/Province
Niedersachsen
ZIP/Postal Code
27342
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Paderborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33098
Country
Germany
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58455
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Nordhausen
State/Province
Thüringen
ZIP/Postal Code
99734
Country
Germany
City
Berlin
ZIP/Postal Code
12099
Country
Germany
City
Bottrop
ZIP/Postal Code
46242
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Wanchai
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
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
Kochi
State/Province
Kerala
ZIP/Postal Code
682026
Country
India
City
Hyderabad
ZIP/Postal Code
500082
Country
India
City
New Delhi
ZIP/Postal Code
110060
Country
India
City
Pune
ZIP/Postal Code
411001
Country
India
City
Bandung
ZIP/Postal Code
40161
Country
Indonesia
City
Jakarta
ZIP/Postal Code
10330
Country
Indonesia
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
City
Medan
ZIP/Postal Code
20152
Country
Indonesia
City
Semarang
ZIP/Postal Code
50241
Country
Indonesia
City
Ballinasloe
State/Province
Co. Galway
Country
Ireland
City
Afula
ZIP/Postal Code
18101
Country
Israel
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
City
Haifa
ZIP/Postal Code
31048
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Safed
ZIP/Postal Code
13100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Chieti
ZIP/Postal Code
66013
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20142
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Venezia
ZIP/Postal Code
30122
Country
Italy
City
Seoul
State/Province
Korea
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Taegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
City
Liepaja
ZIP/Postal Code
LV 3414
Country
Latvia
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Selangor
ZIP/Postal Code
68000
Country
Malaysia
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
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
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
City
Auckland
ZIP/Postal Code
1023
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 South
ZIP/Postal Code
6021
Country
New Zealand
City
Fredrikstad
ZIP/Postal Code
1603
Country
Norway
City
Oslo
ZIP/Postal Code
0407
Country
Norway
City
Rud
ZIP/Postal Code
1309
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Quezon City
ZIP/Postal Code
0850
Country
Philippines
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Krakow
ZIP/Postal Code
31-066
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
City
Poznan
ZIP/Postal Code
60-631
Country
Poland
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-326
Country
Poland
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2132
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2157
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2191
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0157
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
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7460
Country
South Africa
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
City
Valladolid
State/Province
Castilla - León
ZIP/Postal Code
47010
Country
Spain
City
Palma de Mallorca
State/Province
Illes Baleares
ZIP/Postal Code
07010
Country
Spain
City
Requena
State/Province
Valencia
ZIP/Postal Code
46340
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Borås
ZIP/Postal Code
501 82
Country
Sweden
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
City
Genéve 14
State/Province
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
City
Chur
State/Province
Graubünden
ZIP/Postal Code
7000
Country
Switzerland
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
City
Lausanne
State/Province
Waadt
ZIP/Postal Code
1005
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Pathumwan, Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Isleworth
State/Province
London
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22449293
Citation
EINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.
Results Reference
result
PubMed Identifier
23829521
Citation
Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013 Jul 6;11(1):13. doi: 10.1186/1477-9560-11-13.
Results Reference
result
PubMed Identifier
24053656
Citation
Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.
Results Reference
result
PubMed Identifier
24341332
Citation
Wang Y, Wang C, Chen Z, Zhang J, Liu Z, Jin B, Ying K, Liu C, Shao Y, Jing Z, Meng IL, Prins MH, Pap AF, Muller K, Lensing AW; Chinese EINSTEIN Investigators. Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies. Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.
Results Reference
result
PubMed Identifier
24432872
Citation
van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AW. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.
Results Reference
result
PubMed Identifier
30121419
Citation
Ten Cate H, Lensing AWA, Weitz JI, Middeldorp S, Beyer-Westendorf J, Kubitza D, Brighton T, Raskob GE, Mismetti P, Prandoni P, Gebel M, Prins MH. The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients. Thromb Res. 2018 Oct;170:75-83. doi: 10.1016/j.thromres.2018.08.008. Epub 2018 Aug 15.
Results Reference
derived
PubMed Identifier
27535349
Citation
Di Nisio M, Vedovati MC, Riera-Mestre A, Prins MH, Mueller K, Cohen AT, Wells PS, Beyer-Westendorf J, Prandoni P, Bounameaux H, Kubitza D, Schneider J, Pisters R, Fedacko J, Fontes-Carvalho R, Lensing AW. Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies. Thromb Haemost. 2016 Sep 27;116(4):739-46. doi: 10.1160/TH16-02-0087. Epub 2016 Aug 18.
Results Reference
derived
PubMed Identifier
25698905
Citation
Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.
Results Reference
derived
PubMed Identifier
27030066
Citation
Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.
Results Reference
derived
PubMed Identifier
25750589
Citation
Bauersachs RM, Lensing AW, Prins MH, Kubitza D, Pap AF, Decousus H, Beyer-Westendorf J, Prandoni P. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014 Nov 24;12:25. doi: 10.1186/1477-9560-12-25. eCollection 2014.
Results Reference
derived
PubMed Identifier
22371186
Citation
Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28.
Results Reference
derived
Learn more about this trial
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
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