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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00439777




Registration number
NCT00439777
Ethics application status
Date submitted
23/02/2007
Date registered
26/02/2007
Date last updated
27/02/2014

Titles & IDs
Public title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Scientific title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Secondary ID [1] 0 0
2006-004495-13
Secondary ID [2] 0 0
11702b
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Enoxaparin overlapping with and followed by VKA

Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)

Active comparator: Enoxaparin/VKA - 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)


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
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.

Treatment: Drugs: Enoxaparin overlapping with and followed by VKA
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.
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
3-, 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
3-, 6-, or 12-month study treatment period
Secondary outcome [2] 0 0
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
Timepoint [2] 0 0
3-, 6-, or 12-month study treatment period
Secondary outcome [3] 0 0
Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
Timepoint [3] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [4] 0 0
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
Timepoint [4] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [5] 0 0
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
Timepoint [5] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [6] 0 0
Percentage of Participants With All Deaths
Timepoint [6] 0 0
3-, 6- or 12-month study treatment period
Secondary outcome [7] 0 0
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
Timepoint [7] 0 0
3-, 6- or 12-month study treatment period

Eligibility
Key inclusion criteria
* Confirmed acute symptomatic proximal PE with or without symptomatic DVT
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)
* 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.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
4833
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,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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- Woodville South
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- Launceston
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- Box Hill
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- Clayton
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- Geelong
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- Melbourne
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- Fremantle
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- 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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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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5042 - Adelaide
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5011 - Woodville South
Recruitment postcode(s) [15] 0 0
7250 - Launceston
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3128 - Box Hill
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3168 - Clayton
Recruitment postcode(s) [18] 0 0
3220 - Geelong
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3135 - Melbourne
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3181 - Melbourne
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6160 - Fremantle
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6000 - Perth
Recruitment outside Australia
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Washington
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Escaldes - Engordany
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Israel
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Taichung
Country [204] 0 0
Taiwan
State/province [204] 0 0
Taipei
Country [205] 0 0
Thailand
State/province [205] 0 0
Bangkok
Country [206] 0 0
Thailand
State/province [206] 0 0
Chiang Mai
Country [207] 0 0
Thailand
State/province [207] 0 0
Pathumwan, Bangkok
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Devon
Country [209] 0 0
United Kingdom
State/province [209] 0 0
London

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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00439777