Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000597695
Ethics application status
Approved
Date submitted
22/09/2005
Date registered
5/10/2005
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis. The Einstein-DVT dose-finding study.
Scientific title
Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis to assess the dose-effect relationship and determine the optimum dose.
Secondary ID [1] 188 0
Einstein
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute symptomatic deep-vein thrombosis 726 0
Condition category
Condition code
Cardiovascular 803 803 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the dose-effect relationship of once-daily BAY 59-7939 in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) using the combination of (LMW) heparin and vitamin K antagonist (VKA) as comparator.
To determine the optimum once daily dose of BAY 59-7939 for use in phase III studies.

Patients will receive either BAY 59-7939 (20, 30 or 40 mg, once-daily) or the combination of (LMW) heparin/VKA (INR 2.0-3.0). The study duration is 12 weeks followed by an additional observational period of 30 days.
Intervention code [1] 663 0
Treatment: Drugs
Comparator / control treatment
Combination of (low molecular weight) heparin and vitamin K antagonist (VKA) given subcutaneously in doses to provide an International Normaised Ratio (INR) of 2.0 - 3.0.
Control group
Active

Outcomes
Primary outcome [1] 1029 0
1. Symptomatic recurrent DVT or symptomatic fatal or non-fatal pulmonary embolism (PE)
Timepoint [1] 1029 0
At week 12.
Primary outcome [2] 1030 0
2. Deterioration of the thrombotic burden as assessed by repeat compression ultrasound (CUS) and perfusion lung scan (PLS).
Timepoint [2] 1030 0
At week 12.
Primary outcome [3] 1031 0
The principal safety outcome is the combination of major and clinically relevant non-major bleeding.
Timepoint [3] 1031 0
12 weeks
Secondary outcome [1] 1920 0
The separate components of the primary efficacy outcome.
Timepoint [1] 1920 0
At 12 weeks

Eligibility
Key inclusion criteria
1. 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 2. Written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under 18 years of age.2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT3. Other indication for VKA than DVT4. More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization5. Participation in another pharmacotherapeutic study within 30 days6. Creatinine clearance < 30 ml/min, impaired liver function (transaminases > 2 x ULN), or bacterial endocarditis7. Life expectancy <3 months8. Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin 9. Uncontrolled hypertension: systolic blood pressure >200 mmHg and diastolic blood pressure >110 mmHg10. Pregnancy or childbearing potential without proper contraceptive measures11. Any other contraindication listed in the local labeling of warfarin, acenocoumarol, phenprocoumon, fluidione, UFH, enoxaparin, or tinzaparin 12. Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazol, 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)
Done centrally by interactive voice response system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
24/12/2004
Date of last participant enrolment
Anticipated
Actual
11/08/2005
Date of last data collection
Anticipated
Actual
7/12/2005
Sample size
Target
520
Accrual to date
Final
543
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 890 0
Commercial sector/Industry
Name [1] 890 0
Bayer Australia Ltd
Country [1] 890 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Ltd
Address
875 Pacific Highway, Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 752 0
None
Name [1] 752 0
N/A
Address [1] 752 0
Country [1] 752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305293 0
Hopital Nord-Saint Etienne CCPPRB
Ethics committee address [1] 305293 0
Ethics committee country [1] 305293 0
France
Date submitted for ethics approval [1] 305293 0
11/10/2004
Approval date [1] 305293 0
18/10/2004
Ethics approval number [1] 305293 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35786 0
Address 35786 0
Country 35786 0
Phone 35786 0
Fax 35786 0
Email 35786 0
Contact person for public queries
Name 9852 0
Clinical Research Manager
Address 9852 0
Bayer Australia
PO Box 903
Pymble NSW 2073
Country 9852 0
Australia
Phone 9852 0
+61 2 93916140
Fax 9852 0
Email 9852 0
@bayerhealthcare.com
Contact person for scientific queries
Name 780 0
Medical Services Manager
Address 780 0
Bayer Australia
PO Box 903
Pymble NSW 2073
Country 780 0
Australia
Phone 780 0
+61 2 93916140
Fax 780 0
Email 780 0
@bayerhealthcare.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.