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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00439725




Registration number
NCT00439725
Ethics application status
Date submitted
23/02/2007
Date registered
26/02/2007
Date last updated
4/11/2014

Titles & IDs
Public title
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
Scientific title
Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study
Secondary ID [1] 0 0
2006-004494-96
Secondary ID [2] 0 0
11899
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Placebo

Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants were to receive rivaroxaban 20 mg oral tablet once daily

Placebo comparator: Placebo - Participants were to receive matching placebo oral tablet once daily


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.

Treatment: Drugs: Placebo
Patients allocated to placebo will receive a matching placebo tablet once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6- or 12-month study treatment period
Secondary outcome [1] 0 0
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
Timepoint [1] 0 0
6- or 12-month study treatment period
Secondary outcome [2] 0 0
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment
Timepoint [2] 0 0
6- or 12-month study treatment period
Secondary outcome [3] 0 0
Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment
Timepoint [3] 0 0
6- or 12-month study treatment period
Secondary outcome [4] 0 0
Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment
Timepoint [4] 0 0
6- or 12-month study treatment period
Secondary outcome [5] 0 0
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
Timepoint [5] 0 0
6- or 12-month study treatment period
Secondary outcome [6] 0 0
Percentage of Participants With Major Bleeding
Timepoint [6] 0 0
6- or 12-month study treatment period
Secondary outcome [7] 0 0
Percentage of Participants With Clinically Relevant Bleeding
Timepoint [7] 0 0
6- or 12-month study treatment period
Secondary outcome [8] 0 0
Percentage of Participants With All Death
Timepoint [8] 0 0
6- or 12-month study treatment period
Secondary outcome [9] 0 0
Percentage of Participants With Other Vascular Events
Timepoint [9] 0 0
6- or 12-month study treatment period

Eligibility
Key inclusion criteria
* Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Legal lower age limitations (country specific)
* Indication for VKA other than DVT and/or PE
* Patients in whom anticoagulant treatment for their index PE or DVT should be continued
* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
1197
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Garran
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- Gosford
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- Kogarah
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- Lismore
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- St Leonards
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- Sydney
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- Brisbane
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- Redcliffe
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- Southport
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- Woolloongabba
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- Adelaide
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- Box Hill
Recruitment hospital [13] 0 0
- Clayton
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- Geelong
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- Melbourne
Recruitment hospital [16] 0 0
- Prahran
Recruitment hospital [17] 0 0
- Fremantle
Recruitment hospital [18] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2250 - Gosford
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2217 - Kogarah
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2480 - Lismore
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2065 - St Leonards
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2010 - Sydney
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2031 - Sydney
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2139 - Sydney
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2229 - Sydney
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4029 - Brisbane
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4020 - Redcliffe
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4215 - Southport
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4102 - Woolloongabba
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5011 - Adelaide
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5042 - Adelaide
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3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3168 - Clayton
Recruitment postcode(s) [18] 0 0
3220 - Geelong
Recruitment postcode(s) [19] 0 0
3135 - Melbourne
Recruitment postcode(s) [20] 0 0
3181 - Melbourne
Recruitment postcode(s) [21] 0 0
3181 - Prahran
Recruitment postcode(s) [22] 0 0
6160 - Fremantle
Recruitment postcode(s) [23] 0 0
6000 - Perth
Recruitment outside Australia
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Tirol
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Salzburg
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Leuven
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Liege
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Lier
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Namur
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Hellerup
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Baden-Württemberg
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Bayern
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Hessen
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Szentes
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Kerala
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India
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India
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Kolkata
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India
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India
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Pune
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Bandung
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Indonesia
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Jakarta
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Indonesia
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Indonesia
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Israel
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Israel
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Israel
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Kfar Saba
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Israel
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Basel-Landschaft
Country [199] 0 0
Switzerland
State/province [199] 0 0
Genève 14
Country [200] 0 0
Switzerland
State/province [200] 0 0
Graubünden
Country [201] 0 0
Switzerland
State/province [201] 0 0
Valais
Country [202] 0 0
Switzerland
State/province [202] 0 0
Lugano
Country [203] 0 0
Switzerland
State/province [203] 0 0
Luzern
Country [204] 0 0
Switzerland
State/province [204] 0 0
Zürich
Country [205] 0 0
Taiwan
State/province [205] 0 0
Kaohsiung
Country [206] 0 0
Taiwan
State/province [206] 0 0
Tainan
Country [207] 0 0
Taiwan
State/province [207] 0 0
Taipei
Country [208] 0 0
Taiwan
State/province [208] 0 0
Taoyuan
Country [209] 0 0
Thailand
State/province [209] 0 0
Bangkok
Country [210] 0 0
Thailand
State/province [210] 0 0
Pathumwan, Bangkok
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Devon
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Essex
Country [213] 0 0
United Kingdom
State/province [213] 0 0
London
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Lothian
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Merseyside

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, 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 with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).
Trial website
https://clinicaltrials.gov/study/NCT00439725
Trial related presentations / publications
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.
EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.
Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1.
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.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00439725