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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2006-004494-96
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Secondary ID [2]
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11899
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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Clotting disorders
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Respiratory
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0
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Other respiratory disorders / diseases
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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. For definition of DVT/PE, kindly refer to the link in the Protocol section.
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Timepoint [1]
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6- or 12-month study treatment period
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Secondary outcome [1]
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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
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Assessment method [1]
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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), or lung scintigraphy (for PE), and/or case summaries.
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Timepoint [1]
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6- or 12-month study treatment period
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Secondary outcome [2]
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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
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Assessment method [2]
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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), results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [2]
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6- or 12-month study treatment period
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Secondary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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6- or 12-month study treatment period
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Secondary outcome [4]
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Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment
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Assessment method [4]
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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), results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [4]
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0
6- or 12-month study treatment period
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Secondary outcome [5]
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Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
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Assessment method [5]
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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.
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Timepoint [5]
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0
6- or 12-month study treatment period
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Secondary outcome [6]
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Percentage of Participants With Major Bleeding
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Assessment method [6]
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All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 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. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.
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Timepoint [6]
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6- or 12-month study treatment period
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Secondary outcome [7]
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Percentage of Participants With Clinically Relevant Bleeding
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Assessment method [7]
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All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) 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 daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported
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Timepoint [7]
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6- or 12-month study treatment period
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Secondary outcome [8]
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Percentage of Participants With All Death
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Assessment method [8]
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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. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)
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Timepoint [8]
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6- or 12-month study treatment period
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Secondary outcome [9]
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Percentage of Participants With Other Vascular Events
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Assessment method [9]
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All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)
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Timepoint [9]
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6- or 12-month study treatment period
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Eligibility
Key inclusion criteria
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months
with VKA or rivaroxaban
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2009
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Sample size
Target
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Accrual to date
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Final
1197
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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- 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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Recruitment hospital [8]
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- Redcliffe
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Recruitment hospital [9]
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- Southport
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- Woolloongabba
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Recruitment hospital [11]
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- Adelaide
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Recruitment hospital [12]
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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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- Prahran
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Recruitment hospital [17]
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- Fremantle
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Recruitment hospital [18]
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- Perth
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2480 - Lismore
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Recruitment postcode(s) [5]
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2065 - St Leonards
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Recruitment postcode(s) [6]
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2010 - Sydney
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Recruitment postcode(s) [7]
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2031 - Sydney
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Recruitment postcode(s) [8]
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2139 - Sydney
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Recruitment postcode(s) [9]
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2229 - Sydney
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Recruitment postcode(s) [10]
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4029 - Brisbane
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Recruitment postcode(s) [11]
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4020 - Redcliffe
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Recruitment postcode(s) [12]
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4215 - Southport
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Recruitment postcode(s) [13]
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4102 - Woolloongabba
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Recruitment postcode(s) [14]
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5011 - Adelaide
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Recruitment postcode(s) [15]
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5042 - Adelaide
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Recruitment postcode(s) [16]
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3128 - Box Hill
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Recruitment postcode(s) [17]
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3168 - Clayton
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Recruitment postcode(s) [18]
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3220 - Geelong
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Recruitment postcode(s) [19]
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3135 - Melbourne
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Recruitment postcode(s) [20]
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3181 - Melbourne
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Recruitment postcode(s) [21]
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3181 - Prahran
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Recruitment postcode(s) [22]
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6160 - Fremantle
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Recruitment postcode(s) [23]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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Arkansas
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California
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Florida
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Georgia
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Idaho
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Louisiana
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Maryland
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Massachusetts
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North Carolina
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Oklahoma
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Austria
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Steiermark
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Wien
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Bruxelles - Brussel
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Duffel
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Prague 5
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Usti nad Lebem
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Aarhus C
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Hellerup
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Finland
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Seinäjoki
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Agen Cedex 9
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France
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France
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Clamart
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Colombes
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Dijon
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Grenoble
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Nantes
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Nimes Cedex 9
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France
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Orthez
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France
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Paris
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France
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Israel
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Israel
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Israel
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Rehovot
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Israel
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Israel
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Italy
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Italy
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Italy
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Korea, Republic of
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Daegu
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Bangkok
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Thailand
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Pathumwan, Bangkok
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United Kingdom
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Lothian
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United Kingdom
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Merseyside
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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0
0
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Ethics approval
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00439725
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Public notes
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Contacts
Principal investigator
Name
0
0
Bayer Study Director
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0
0
Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00439725
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