Pulmonary EmbolismPhase 3NCT00439777
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin overlapping with and followed by VKA in people with Pulmonary Embolism, run by Bayer at 305 sites in 39 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin overlapping with and followed by VKA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,833 participants
- Where
- 305 sitesin 39 countries
- Study dates
- Mar 2007to Dec 2011
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed acute symptomatic proximal PE with or without symptomatic DVT
Who cannot join
- 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.
Trial locations and contacts
305 sites in 39 countries.
305 sites in 39 countries
France34 sites
Study site
Agen, 47923
Study site
Amiens, 80000
Study site
Angers, 49033
Study site
Arras, 62000
Study site
Besançon, 25000
Study site
Bordeaux, 33000
Study site
Brest, 29609
Study site
Castelnau-le-Lez, 34170
Study site
Clamart, 92141
Study site
Clermont-Ferrand, 63000
Study site
Colombes, 92701
Study site
Dijon, 21000
Study site
Grenoble, 38043
Study site
Limoges, 87042
Study site
Metz-Tessy, 74370
Study site
Montpellier, 34295
Study site
Nantes, 44000
Study site
Nice, 06002
Study site
Orthez, 64300
Study site
Paris, 75004
Study site
Paris, 75015
Study site
Paris, 75475
Study site
Paris, 75877
Study site
Paris, 75908
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Pierre-Bénite, 69495
Study site
Roanne, 42328
Study site
Rouen, 76031
Study site
Saint-Etienne, 42055
Study site
Strasbourg, 67091
Study site
Toulon, 83000
Study site
Toulouse, 31403
Study site
Valenciennes, 59322
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vernon, 27200
Germany26 sites
Study site
Augsburg, Bavaria, 86156
Study site
Berlin, State of Berlin, 12099
Study site
Bottrop, 46242
Study site
Bruchsal, Baden-Wurttemberg, 76646
Study site
Darmstadt, Hesse, 64297
Study site
Dresden, Saxony, 01307
Study site
Essen, North Rhine-Westphalia, 45122
Study site
Frankfurt am Main, Hesse, 60590
Study site
Frankfurt am Main, Hesse, 60596
Study site
Greifswald, Mecklenburg-Vorpommern, 17475
Study site
Halle, Saxony-Anhalt, 06120
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20251
Study site
Heidelberg, Baden-Wurttemberg, 69115
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Karlsbad, Baden-Wurttemberg, 76307
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
München, Bavaria, 80331
Study site
München, Bavaria, 81377
Study site
Neckargemünd, Baden-Wurttemberg, 69151
Study site
Nordhausen, Thuringia, 99734
Study site
Paderborn, North Rhine-Westphalia, 33098
Study site
Rotenburg (Wümme), Lower Saxony, 27342
Study site
Tübingen, Baden-Wurttemberg, 72076
Study site
Witten, North Rhine-Westphalia, 58455
Study site
Würzburg, Bavaria, 97080
United States23 sites
Study site
Albuquerque, New Mexico, 87108
Study site
Baltimore, Maryland, 21215
Study site
Bay Pines, Florida, 33744
Study site
Boston, Massachusetts, 02215
Study site
Camp Hill, Pennsylvania, 17011
Study site
Chapel Hill, North Carolina, 27599-7035
Study site
Chesterfield, Missouri, 63017
Study site
Covington, Louisiana, 70433
Study site
Fredericksburg, Virginia, 22401
Study site
Greensboro, North Carolina, 27401
Study site
Greensboro, North Carolina, 27403
Study site
Idaho Falls, Idaho, 83404
Study site
Little Rock, Arkansas, 72205
Study site
Miami, Florida, 33136-1096
Study site
Miami, Florida, 33136
Study site
Murray, Utah, 84107
Study site
Oklahoma City, Oklahoma, 73104
Study site
Pittsburgh, Pennsylvania, 15224
Study site
Redlands, California, 92373
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
Spokane, Washington, 99204
Study site
Tacoma, Washington, 98405
Australia22 sites
Study site
Adelaide, South Australia, 5042
Study site
Box Hill, Victoria, 3128
Study site
Brisbane, Queensland, 4029
Study site
Clayton, Victoria, 3168
Study site
Fremantle, Western Australia, 6160
Study site
Garran, Australian Capital Territory, 2605
Study site
Geelong, Victoria, 3220
Study site
Gosford, New South Wales, 2250
Study site
Kogarah, New South Wales, 2217
Study site
Launceston, Tasmania, 7250
Study site
Lismore, New South Wales, 2480
Study site
Melbourne, Victoria, 3135
Study site
Melbourne, Victoria, 3181
Study site
Perth, Western Australia, 6000
Study site
Redcliffe, Queensland, 4020
Study site
Southport, Queensland, 4215
Study site
St Leonards, New South Wales, 2065
Study site
Sydney, New South Wales, 2031
Study site
Sydney, New South Wales, 2139
Study site
Sydney, New South Wales, 2229
Study site
Woodville South, South Australia, 5011
Study site
Woolloongabba, Queensland, 4102
China19 sites
Study site
Beijing, 100020
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Beijing, 100029
Study site
Beijing, 100037
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Beijing, 100038
Study site
Beijing, 100044
Study site
Beijing, 100730
Study site
Beijing, 100853
Study site
Guangzhou, Guangdong, 510080
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Guangzhou, Guangdong, 510120
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Guangzhou, Guangdong
Study site
Hangzhou, Zhejiang, 310016
Study site
Harbin, Heilongjiang, 150086
Study site
Nanning, Guangxi, 530021
Study site
Shanghai, 200001
Study site
Shanghai, 200032
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Shanghai, 200433
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Shenyang, Liaoning, 110016
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Suzhou, Jiangsu, 215004
Study site
Wuhan, Hubei, 430022
Italy14 sites
Study site
Bologna, 40138
Study site
Chieti, 66013
Study site
Milan, 20122
Study site
Milan, 20132
Study site
Milan, 20142
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Padova, 35128
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Palermo, 90127
Study site
Parma, 43100
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Pavia, 27100
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Piacenza, 29100
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Reggio Emilia, 42100
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Rozzano, Milano, 20089
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Varese, 21100
Study site
Venezia, 30122
Belgium13 sites
Study site
Aalst, 9300
Study site
Bruxelles - Brussel, 1070
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Bruxelles - Brussel, 1200
Study site
Duffel, 2570
Study site
Genk, 3600
Study site
Ghent, 9000
Study site
Hasselt, 3500
Study site
Leuven, 3000
Study site
Liège, 4000
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Lier, 2500
Study site
Namur, 5000
Study site
Yvoir, 5530
Study site
Zottegem, 9620
Israel12 sites
Study site
Afula, 18101
Study site
Ashkelon, 78278
Study site
Haifa, Israel, 34362
Study site
Haifa, 31048
Study site
Haifa, 31096
Study site
Holon, Israel, 58100
Study site
Jerusalem, Israel, 91120
Study site
Kfar Saba, 44281
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Petah Tikva, Israel, 49100
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Rehovot, 76100
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Safed, 13100
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Tel Aviv, 64239
Hungary10 sites
Study site
Budapest, 1096
Study site
Budapest, 1115
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Debrecen, 4032
Study site
Kecskemét, 6000
Study site
Kistarcsa, 2143
Study site
Miskolc, 3526
Study site
Szekszárd, 7100
Study site
Szentes, 6600
Study site
Szombathely, 9700
Study site
Zalaegerszeg, 8900
Poland10 sites
Study site
Bialystok, 15-276
Study site
Krakow, 31-066
Study site
Lodz, 90-153
Study site
Lublin, 20-081
Study site
Poznan, 60-631
Study site
Poznan, 61-848
Study site
Torun, 87-100
Study site
Warsaw, 01-138
Study site
Wroclaw, 50-326
Study site
Wroclaw, 51-124
South Africa10 sites
Study site
Cape Town, Western Cape, 7460
Study site
Johannesburg, Gauteng, 2132
Study site
Johannesburg, Gauteng, 2157
Study site
Johannesburg, Gauteng, 2191
Study site
Pretoria, Gauteng, 0084
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Pretoria, Gauteng, 0157
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Pretoria, Gauteng, 0181
Study site
Roodepoort, Gauteng, 1724
Study site
Somerset West, Western Cape, 7130
Study site
Worcester, Western Cape, 6850
Brazil9 sites
Study site
Botucatu, São Paulo, 18618 000
Study site
Curitiba, Paraná, 80050-350
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Londrina, Paraná, 86038440
Study site
Rio de Janeiro
Study site
São Paulo, São Paulo, 01323-001
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São Paulo, São Paulo, 01509-900
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São Paulo, São Paulo, 04039-004
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São Paulo, São Paulo, 08270-070
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Sorocaba, São Paulo, 18031-000
Spain9 sites
Study site
Barcelona, Barcelona, 08025
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Barcelona, Barcelona, 08036
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Girona, Girona, 17007
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Madrid, Madrid, 28034
Study site
Palma de Mallorca, Illes Baleares, 07010
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Pamplona, Pamplona, 31008
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Requena, Valencia, 46340
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Terrassa, Barcelona, 08221
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Valladolid, Castille and León, 47010
Czechia8 sites
Study site
Kladno, 27259
Study site
Ostrava, 728 80
Study site
Ostrava-Poruba, 708 52
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Prague, 110 00
Study site
Prague, 12800
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Prague, 150 00
Study site
Rakovník, 269 01
Study site
Usti Nad Lebem, 401 13
Austria7 sites
Study site
Feldkirch, Vorarlberg, 6807
Study site
Graz, Styria, 8036
Study site
Innsbruck, 6020
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Linz, 4010
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Vienna, State of Vienna, 1090
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Vienna, State of Vienna, 1140
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Vienna, State of Vienna, 1171
Netherlands7 sites
Study site
Amsterdam, 1105 AZ
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Arnhem, 6815 AD
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Enschede, 7511 JX
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Groningen, 9713 GZ
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Hoofddorp, 2134 TM
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Maastricht, 6229 HX
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Zwolle, 8025 AB
Switzerland7 sites
Study site
Bern, Canton of Bern, 3010
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Chur, Kanton Graubünden, 7000
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Genéve 14, Genève 14, 1211
Study site
Lausanne, Canton of Vaud, 1005
Study site
Lausanne, Canton of Vaud, 1011
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Lucerne, 6000
Study site
Zurich, Canton of Zurich, 8091
New Zealand6 sites
Study site
Auckland, 0622
Study site
Auckland, 1023
Study site
Auckland, 2024
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Christchurch, 8011
Study site
Palmerston North, 4414
Study site
Wellington South, 6021
Sweden6 sites
Study site
Borås, 501 82
Study site
Gothenburg, 413 45
Study site
Gothenburg, 416 85
Study site
Jönköping, 551 85
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Stockholm, 118 83
Study site
Sundsvall, 851 86
Canada5 sites
Study site
London, Ontario, N6A 4G5
Study site
Ottawa, Ontario, K1Y 4E9
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Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M6R 1B5
Study site
Winnipeg, Manitoba, R2H 2A6
Indonesia5 sites
Study site
Bandung, 40161
Study site
Jakarta, Indonesia, 10330
Study site
Jakarta, 10430
Study site
Medan, 20152
Study site
Semarang, 50241
United Kingdom5 sites
Study site
Isleworth, London, TW7 6AF
Study site
London, London, SE1 7EH
Study site
London, London, SE5 9RS
Study site
London
Study site
Plymouth, Devon, PL6 8DH
India4 sites
Study site
Hyderabad, 500082
Study site
Kochi, Kerala, 682026
Study site
New Delhi, 110060
Study site
Pune, 411001
Norway4 sites
Study site
Fredrikstad, 1603
Study site
Oslo, 0407
Study site
Rud, 1309
Study site
Trondheim, 7006
South Korea4 sites
Study site
Daegu, 705-718
Study site
Seoul, Korea, 110-744
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Seoul, 120-752
Study site
Taegu, 700-712
Taiwan4 sites
Study site
Taichung, 40705
Study site
Taipei, 10016
Study site
Taipei, 112
Study site
Taipei, 220
Denmark3 sites
Study site
Aarhus C, 8000
Study site
Brædstrup, 8740
Study site
Frederiksberg, 2000F
Thailand3 sites
Study site
Bangkok, 10400
Study site
Chiang Mai, 50200
Study site
Pathumwan, Bangkok, Thailand, 10330
Philippines2 sites
Study site
Quezon City, 0850
Study site
Quezon City, 1102
Andorra1 site
Study site
Les Escaldes
About this study
Official title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
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).
Read the detailed description
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.
- Conditions
- Pulmonary Embolism
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin overlapping with and followed by VKA
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
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.
Enoxaparin overlapping with and followed by VKADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Experimental | Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.) Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Enoxaparin/VKA | Active comparator | 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) Receives: Drug: Enoxaparin overlapping with and followed by VKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-, 6-, or 12-month study treatment period
Secondary outcomes (7)
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.
Measured: 3-, 6-, or 12-month study treatment period
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.
Measured: 3-, 6-, or 12-month study treatment period
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.
Measured: 3-, 6- or 12-month study treatment period
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.
Measured: 3-, 6- or 12-month study treatment period
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.
Measured: 3-, 6- or 12-month study treatment period
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.
Measured: 3-, 6- or 12-month study treatment period
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.
Measured: 3-, 6- or 12-month study treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439777
- Sponsor's protocol ID
- 11702b
- Other IDs
- 2006-004495-13
- Status last verified
- Jan 2014
- First submitted
- 23 Feb 2007
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22449293Prins 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.
PubMed 23829521Prins 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.
PubMed 24053656Wang 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.
PubMed 24341332van 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.
PubMed 24432872Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.
PubMed 40163217Ten 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.
PubMed 30121419Di 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.
PubMed 27535349Prins 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.
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