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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00395772




Registration number
NCT00395772
Ethics application status
Date submitted
2/11/2006
Date registered
3/11/2006
Date last updated
28/10/2014

Titles & IDs
Public title
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
Scientific title
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.
Secondary ID [1] 0 0
EudraCT: 2004-002171-16
Secondary ID [2] 0 0
11528
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
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - Xarelto (Rivaroxaban, BAY59-7939)
Treatment: Drugs - (LMW) Heparin + Vitamin K Antagonist

Active Comparator: Arm 4 -

Experimental: Arm 1 -

Experimental: Arm 2 -

Experimental: Arm 3 -


Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 20 mg once daily (od) for 12 weeks

Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 30 mg od for 12 weeks

Treatment: Drugs: Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 40 mg od for 12 weeks

Treatment: Drugs: (LMW) Heparin + Vitamin K Antagonist
Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks.
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
The separate components of the primary efficacy outcome at 12 weeks.
Timepoint [2] 0 0
12 weeks

Eligibility
Key inclusion criteria
- Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis
involving at least the upper third part of the calf veins, without concomitant
symptomatic PE

- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
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

- Other indication for VKA than PE/DVT

- More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)
heparin or more than a single dose of VKA prior to randomization

- Participation in another pharmacotherapeutic study within the prior 30 days

- Creatinine clearance < 30 mL/min, impaired liver function (transaminases > 2 x ULN),
or bacterial endocarditis

- Life expectancy < 3 months

- Active bleeding or high risk for bleeding contraindicating treatment with (LMW)
heparin

- Uncontrolled hypertension: systolic blood pressure > 200 mmHg and diastolic blood
pressure > 110 mmHg

- Pregnancy or childbearing potential without proper contraceptive measures

- Any other contraindication listed in the labeling of warfarin, acenocoumarol,
phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin

- Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g.
ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior
to randomization and during the study

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2217 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment postcode(s) [6] 0 0
3168 - Melbourne
Recruitment postcode(s) [7] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Mexico
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Brazil
State/province [5] 0 0
Paraná
Country [6] 0 0
Brazil
State/province [6] 0 0
RS
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Hradec Kralove
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Karlovy Vary
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Plzen
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Praha 10
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha 5
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Usti nad Labem
Country [19] 0 0
Denmark
State/province [19] 0 0
Aarhus
Country [20] 0 0
Denmark
State/province [20] 0 0
Brædstrup
Country [21] 0 0
Denmark
State/province [21] 0 0
Frederiksberg
Country [22] 0 0
France
State/province [22] 0 0
Brest Cedex
Country [23] 0 0
France
State/province [23] 0 0
Grenoble
Country [24] 0 0
France
State/province [24] 0 0
Montpellier Cedex
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 15
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Saint-etienne
Country [28] 0 0
France
State/province [28] 0 0
Valenciennes Cedex
Country [29] 0 0
Israel
State/province [29] 0 0
Afula
Country [30] 0 0
Israel
State/province [30] 0 0
Ashkelon
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Holon
Country [33] 0 0
Israel
State/province [33] 0 0
Kfar Saba
Country [34] 0 0
Israel
State/province [34] 0 0
Petach Tikva
Country [35] 0 0
Israel
State/province [35] 0 0
Safed
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Aviv
Country [37] 0 0
Israel
State/province [37] 0 0
Tel Hashomer
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Padova
Country [40] 0 0
Italy
State/province [40] 0 0
Pavia
Country [41] 0 0
Italy
State/province [41] 0 0
Reggio Emilia
Country [42] 0 0
Italy
State/province [42] 0 0
Venezia
Country [43] 0 0
Netherlands
State/province [43] 0 0
Amersfoort
Country [44] 0 0
Netherlands
State/province [44] 0 0
Amsterdam
Country [45] 0 0
Netherlands
State/province [45] 0 0
Arnhem
Country [46] 0 0
Netherlands
State/province [46] 0 0
Groningen
Country [47] 0 0
Netherlands
State/province [47] 0 0
Hoofddorp
Country [48] 0 0
Netherlands
State/province [48] 0 0
Maastricht
Country [49] 0 0
Netherlands
State/province [49] 0 0
Sittard-geleen
Country [50] 0 0
Netherlands
State/province [50] 0 0
Zwolle
Country [51] 0 0
Poland
State/province [51] 0 0
Bydgoszcz
Country [52] 0 0
Poland
State/province [52] 0 0
Warszawa
Country [53] 0 0
Poland
State/province [53] 0 0
Wroclaw
Country [54] 0 0
South Africa
State/province [54] 0 0
Gauteng
Country [55] 0 0
Sweden
State/province [55] 0 0
Göteborg
Country [56] 0 0
Sweden
State/province [56] 0 0
Jönköping
Country [57] 0 0
Sweden
State/province [57] 0 0
Stockholm
Country [58] 0 0
Sweden
State/province [58] 0 0
Västervik

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
The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the
safety and effectiveness of this new drug with the standard way of treatment of deep vein
thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new
events of thrombosis and pulmonary embolism and bleeding risk.
Trial website
https://clinicaltrials.gov/show/NCT00395772
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

Summary results
Other publications