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AzTrials

Pulmonary EmbolismPhase 3EinsteinChoiceNCT02064439

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

A Phase 3 study testing BAY 59-7939 and ASA in people with Pulmonary Embolism and Thromboembolism, run by Bayer at 266 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism, Thromboembolism, Thrombosis
What is being tested?
BAY 59-7939 and ASA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,365 participants
Where
266 sitesin 31 countries
Study dates
5 Mar 2014to 4 Nov 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

266 sites in 31 countries.

266 sites in 31 countries

China38 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100037

  • Study site

    Beijing, 100053

  • Study site

    Beijing, 100730

  • Study site

    Changchun, Jilin, 130000

  • Study site

    Changsha, Hunan, 410011

  • Study site

    Changsha, Hunan, 410013

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Fuzhou, Fujian, 350025

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou, Guangdong, 510120

  • Study site

    Hangzhou, Zhejiang, 310003

  • Study site

    Hangzhou, Zhejiang, 310016

  • Study site

    Harbin, Heilongjiang

  • Study site

    Jinan, Shandong, 250012

  • Study site

    Kunming, Yunnan, 650032

  • Study site

    Nanning, Guangxi, 530021

  • Study site

    Nantong, Jiangsu, 226001

  • Study site

    Qingdao, Shandong, 266000

  • Study site

    Shanghai, 200001

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200233

  • Study site

    Shanghai, 200433

  • Study site

    Shengyang, Liaoning, 110004

  • Study site

    Shenyang, Liaoning, 110001

  • Study site

    Shijiazhuang, Hebei, 050000

  • Study site

    Suzhou, Jiangsu, 215004

  • Study site

    Taiyuan, Shanxi, 030001

  • Study site

    Tianjin, 300052

  • Study site

    Tianjin, 300121

  • Study site

    Tianjin, 300211

  • Study site

    Wenzhou, Zhejiang, 325000

  • Study site

    Wuhan, Hubei, 430032

  • Study site

    Xi'an, Shaanxi, 710032

  • Study site

    Xi'an, Shaanxi, 710061

  • Study site

    Yinchuan, Ningxia, 750004

Other trials in China

United States24 sites

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02114-2696

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Butte, Montana, 59701

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Ohio, 43210-1240

  • Study site

    Denver, Colorado, 80262

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fredericksburg, Virginia, 22401

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Joliet, Illinois, 60435

  • Study site

    La Jolla, California, 92037

  • Study site

    Las Vegas, Nevada, 89169

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Rockport, Maine, 04856

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Seattle, Washington, 98104

  • Study site

    Spokane, Washington, 99216

  • Study site

    Tacoma, Washington, 98405-2433

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Ventura, California, 93003

Other trials in United States

France24 sites

  • Study site

    Angers, 49933

  • Study site

    Arras, 62000

  • Study site

    Besançon, 25030

  • Study site

    Bois-Guillaume, 76320

  • Study site

    Brest, 29240

  • Study site

    Brest, 29609

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Colombes, 92701

  • Study site

    Dijon, 21000

  • Study site

    Grenoble, 38043

  • Study site

    Le Kremlin-Bicêtre, 94275

  • Study site

    Le Mans, 72037

  • Study site

    Limoges, 87042

  • Study site

    Nice, 06002

  • Study site

    Paris, 75475

  • Study site

    Paris, 75674

  • Study site

    Paris, 75908

  • Study site

    Quimper, 29000

  • Study site

    Saint-Etienne, 42055

  • Study site

    Strasbourg, 67091

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31403

  • Study site

    Vernon, 27200

Other trials in France

Canada13 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Hamilton, Ontario, L8V 1C3

  • Study site

    London, Ontario, N6A 4G5

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Montreal, Quebec, H3T 1M5

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Australia12 sites

  • Study site

    Box Hill, 3128

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Concord, New South Wales, 2139

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Lismore, New South Wales, 2480

  • Study site

    Melbourne, 3004

  • Study site

    Randwick, New South Wales, 2031

  • Study site

    Redcliffe, 4020

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Germany11 sites

  • Study site

    Berlin, 10787

  • Study site

    Darmstadt, Hesse, 64297

  • Study site

    Dresden, Saxony, 01067

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Karlsbad, 76307

  • Study site

    Magdeburg, Saxony-Anhalt, 39112

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 80336

  • Study site

    Witten, North Rhine-Westphalia, 58448

Other trials in Germany

Russia11 sites

  • Study site

    Barnaul, 656045

  • Study site

    Moscow, 111539

  • Study site

    Moscow, 121552

  • Study site

    Novosibirsk, 630055

  • Study site

    Novosibirsk, 630087

  • Study site

    Rostov-on-Don, 344022

  • Study site

    Ryazan, 390026

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg

  • Study site

    Sochi, 354057

  • Study site

    Tver', 170036

Other trials in Russia

Hungary10 sites

  • Study site

    Baja, 6500

  • Study site

    Budapest, 1115

  • Study site

    Debrecen, 4032

  • Study site

    Gyula, 5700

  • Study site

    Kecskemét, 6000

  • Study site

    Miskolc, 3526

  • Study site

    Pécs, 7624

  • Study site

    Szentes, 6600

  • Study site

    Szombathely, 9700

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Netherlands10 sites

  • Study site

    Alkmaar, 1815 JD

  • Study site

    Almere Stad, 1315 RA

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Assen, 9401 RK

  • Study site

    Dordrecht, 3318 AT

  • Study site

    Groningen, 9713 GZ

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Maastricht, 6229 HX

  • Study site

    Sittard, 6131 BK

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Brazil9 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-221

  • Study site

    Campinas, São Paulo, 13083-970

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Rio de Janeiro

  • Study site

    Santo André, São Paulo, 09060-650

  • Study site

    Santo André, São Paulo, 09190-615

  • Study site

    São Paulo, São Paulo, 01323-001

  • Study site

    São Paulo, São Paulo, 04039-004

  • Study site

    São Paulo, 05403-900

Other trials in Brazil

Czechia9 sites

  • Study site

    Kladno, 27259

  • Study site

    Liberec, 46063

  • Study site

    Litomyšl, 570 14

  • Study site

    Ostrava, 708 52

  • Study site

    Ostrava, 728 80

  • Study site

    Prague, 110 00

  • Study site

    Prague, 118 33

  • Study site

    Prague, 150 06

  • Study site

    Ústí nad Labem, 401 13

Other trials in Czechia

Israel9 sites

  • Study site

    Afula, 1834111

  • Study site

    Haifa, 3109601

  • Study site

    Haifa, 3339419

  • Study site

    Holon, 5810001

  • Study site

    Kfar Saba, 4428164

  • Study site

    Nahariya, 2210001

  • Study site

    Petah Tikva, 4941492

  • Study site

    Safed, 1311001

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Italy9 sites

  • Study site

    Chieti, Abruzzo, 66013

  • Study site

    Cosenza, Calabria, 87100

  • Study site

    Padova, Veneto, 35128

  • Study site

    Perugia, Umbria, 06156

  • Study site

    Piacenza, Emilia-Romagna, 29121

  • Study site

    Reggio Emilia, Emilia-Romagna, 42100

  • Study site

    Treviso, Veneto, 31029

  • Study site

    Treviso, Veneto, 31033

  • Study site

    Varese, Lombardy, 21100

Other trials in Italy

Mexico8 sites

  • Study site

    Aguascalientes, 20230

  • Study site

    Chihuahua City, 31203

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    Guadalajara, Jalisco, 44340

  • Study site

    León, Guanajuato, 37000

  • Study site

    Mérida, Yucatán, 97129

  • Study site

    Monterrey, Nuevo León, 64718

  • Study site

    Xalapa, Veracruz, 91020

Other trials in Mexico

Denmark7 sites

  • Study site

    Aarhus N, 8200

  • Study site

    Copenhagen, 2300

  • Study site

    Glostrup Municipality, 2600

  • Study site

    Hellerup, 2900

  • Study site

    Herning, 7400

  • Study site

    København NV, 2400

  • Study site

    Svendborg, 5700

Other trials in Denmark

South Africa7 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Johannesburg, Gauteng, 2132

  • Study site

    Johannesburg, Gauteng, 2191

  • Study site

    Pretoria, Gauteng, 0181

  • Study site

    Pretoria West, Gauteng, 0082

  • Study site

    Roodepoort, Gauteng, 1724

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

New Zealand6 sites

  • Study site

    Auckland, 1023

  • Study site

    Auckland, 1309

  • Study site

    Auckland, 2024

  • Study site

    Christchurch, 8011

  • Study site

    Palmerston North, 4414

  • Study site

    Wellington, 6021

Other trials in New Zealand

South Korea6 sites

  • Study site

    Busan, 602-739

  • Study site

    Daegu, 705-718

  • Study site

    Donggu, Gwangju Gwang''yeogsi, 501-757

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-710

Other trials in South Korea

Switzerland6 sites

  • Study site

    Basel, Canton of Basel-City, 4031

  • Study site

    Bern, 3010

  • Study site

    Fribourg, 1700

  • Study site

    Geneva, 1205

  • Study site

    Lausanne, Canton of Vaud, 1011

  • Study site

    Lucerne, 6000

Other trials in Switzerland

Belgium5 sites

  • Study site

    Aalst, 9300

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Hasselt, 3500

  • Study site

    Leuven, 3000

Other trials in Belgium

Poland5 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-681

  • Study site

    Poznan, 60-631

  • Study site

    Warsaw, 01-138

  • Study site

    Wroclaw, 51-124

Other trials in Poland

Spain5 sites

  • Study site

    Girona, 17007

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28007

  • Study site

    San Sebastián de los Reyes, Madrid, 28702

  • Study site

    Torrevieja, Alicante, 03186

Other trials in Spain

United Kingdom5 sites

  • Study site

    Cardiff, CF14 4XW

  • Study site

    Hull, Humberside, HU3 2JZ

  • Study site

    London, SE1 7EH

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

  • Study site

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Austria3 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, Tyrol, 6020

  • Study site

    Vienna, 1090

Other trials in Austria

Taiwan3 sites

  • Study site

    New Taipei City, 220

  • Study site

    Taichung, 40447

  • Study site

    Taipei, 11217

Other trials in Taiwan

Norway2 sites

  • Study site

    Fredrikstad, 1603

  • Study site

    Oslo, 0450

Other trials in Norway

Sweden2 sites

  • Study site

    Gothenburg, 416 85

  • Study site

    Kristianstad, 29185

Other trials in Sweden

Thailand2 sites

  • Study site

    Bangkok, 10400

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Turkey (Türkiye)2 sites

  • Study site

    Istanbul, 34-300

  • Study site

    Istanbul, 34760

Other trials in Turkey (Türkiye)

Vietnam2 sites

  • Study site

    Hà Nội

  • Study site

    Ho Chi Minh City, 70000

Other trials in Vietnam

Philippines1 site

  • Study site

    Quezon City, NCR 1100

Other trials in Philippines

About this study

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

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

Being tested
BAY 59-7939, ASA
Keywords
deep vein thrombosis, pulmonary embolism, long-term prevention of recurrent symptomatic VTE
Medical subject headings
Pulmonary Embolism, Thromboembolism, Thrombosis, Venous Thrombosis, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY 59-7939Drug

    10 mg tablet once daily for 12 months

  • BAY 59-7939Drug

    20 mg tablet once daily for 12 months

  • ASADrug

    100 mg tablet once daily for 12 months

Study groups in NCT02064439
Study groupRoleWhat they receive
Arm 1ExperimentalRivaroxaban 10 mg once daily for 12 months
Receives: Drug: BAY 59-7939
Arm 2ExperimentalRivaroxaban 20 mg once daily for 12 months
Receives: Drug: BAY 59-7939
Arm 3Active comparatorASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Receives: Drug: ASA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12 months, at least 6 months

  2. 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.

    Measured: Up to 12 months, at least 6 months

Secondary outcomes (2)

  1. 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.

    Measured: Up to 12 months, at least 6 months

  2. 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.

    Measured: Up to 12 months, at least 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study start5 Mar 2014
  3. Primary completion22 Sep 2016
  4. Study completion4 Nov 2016

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02064439
Sponsor's protocol ID
16416
Other IDs
2013-000619-26
Acronym
EinsteinChoice
Status last verified
Nov 2017
First submitted
14 Feb 2014
Last updated
19 Dec 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.

    PubMed 25994838

  • Dobesh 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 40163217

  • Yamada N, Fu W, Shi Z, Park KH, Kim HS, Dai X, Lensing AW, Pap AF, Kohno T, Tajima T, Watakabe T, Mitsumori T. Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE. Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4.

    PubMed 38844941

  • 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.

    PubMed 35876829

  • 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.

    PubMed 28316279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAY 59-7939 and ASA in people with Pulmonary Embolism and Thromboembolism, run by Bayer at 266 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in China, United States, France, Canada, Australia and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism (time frame: Up to 12 months, at least 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02064439, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.

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