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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
* 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
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
543
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/study/NCT00395772
Trial related presentations / publications
Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, Misselwitz F, Raskob G, Schellong S, Segers A; Einstein-DVT Dose-Ranging Study investigators. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008 Sep 15;112(6):2242-7. doi: 10.1182/blood-2008-05-160143. Epub 2008 Jul 11.
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/NCT00395772