Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000601639
Ethics application status
Approved
Date submitted
5/10/2005
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
Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis. A phase II dose finding and proof of principle trial.
ODIXa-DVT
Scientific title
Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis. A phase II dose finding and proof of principle trial.
ODIXa-DVT
Secondary ID [1] 300463 0
Bay 59-7939 / 11223
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep vein thrombosis 730 0
Condition category
Condition code
Cardiovascular 808 808 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the saftey and efficacy of enoxaparin and vitamin K-antagonist and to find the optimal dose of BAY 59-7939.
Patients with acute symptomatic proximal deep vein thrombosis objectively confirmed by ultrasound examination will be randomized into the study. Patients with symptomatic pulmonary embolism at study entry will be excluded.
The patients will be randomized centrally into one of the following five treatment arms:
I: 10 mg bid BAY 59 7939 tablets.
II: 20 mg bid BAY 59 7939 tablets.
III: 30 mg bid BAY 59 7939 tablets.
IV: 40 mg od BAY 59 7939 tablets.
V: Enoxaparin sodium injections/vitamin K-antagonist tablets (warfarin, phenprocoumon or acenocoumarol).
The dose arms of BAY 59 7939 will be blinded. The active comparator enoxaparin/vitamin K-antagonist will be open labelled.

The main treatment period of 21 days is followed by an extended period of trial therapy until week 12 (Day 84).
Patients should continue with the extended trial therapy to Day 84 (week 12) after the primary outcome assessment at Day 21 if the locally reported assessment of CCUS and/or perfusion lung scanning indicates no deterioration of either. If there is a locally reported but asymptomatic deterioration of either result, then investigators will apply their clinical judgment to decide if such patients should proceed with the extended period of trial therapy to Day 84 (week 12).

A follow-up visit is required 30 days after the last intake of study medication.
Intervention code [1] 699 0
Treatment: Drugs
Comparator / control treatment
Combination of enoxaparin sodium and vitamin K antagonist given subcutaneously daily in doses to provide an International Normaised Ratio (INR) of 2.0 - 3.0. Treatment period is 3 weeks.
Control group
Active

Outcomes
Primary outcome [1] 1036 0
The response to treatment as determined by Complete Compression Ultrasound (CCUS)
Timepoint [1] 1036 0
After 3 weeks of treatment.
Secondary outcome [1] 1925 0
Response to treatment as assessed by CCUS.
Timepoint [1] 1925 0
At Day 84
Secondary outcome [2] 1926 0
Residual vein diameter as assessed by CCUS.
Timepoint [2] 1926 0
On Day 84.
Secondary outcome [3] 1927 0
Incidence of symptomatic and confirmed recurrence or extension of DVT.
Timepoint [3] 1927 0
During the 3 months treatment period.
Secondary outcome [4] 1928 0
Incidence of symptomatic and confirmed PE
Timepoint [4] 1928 0
During the 3 months treatment period.
Secondary outcome [5] 1929 0
Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths
Timepoint [5] 1929 0
During the 3 months treatment period.
Secondary outcome [6] 1930 0
Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths related to VTE
Timepoint [6] 1930 0
During the 3 months treatment period.
Secondary outcome [7] 1931 0
Incidence of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE.
Timepoint [7] 1931 0
Within 30 days after stop of treatment with study drug.

Eligibility
Key inclusion criteria
Patients with acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Related to medical historyTIA or ischemic stroke within the last 6 months prior to study entry.History of heparin-induced thrombocytopenia, allergy to heparins.Intracerebral or intraocular bleeding within the last 6 months prior to study entry.History of gastrointestinal bleeding within the last 6 months prior to the study.History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug.Related to current symptoms or findingsFemale with childbearing potential using no adequate contraception method.Pregnant and breastfeeding women.Symptomatic pulmonary embolism.Surgery either major or minor within the last 10 days.Neurosurgery within the last 4 weeks.Heart insufficiency NYHA III-IV.Bacterial endocarditis.Known congenital or acquired hemorrhagic diathesis including patients with acquired or congenital thrombopathy.Thrombocytopenia.Macroscopic hematuria.Uncontrolled severe hypertension.Impaired liver function (transaminases > 2 x ULN).Impaired renal function.Patients with known brain metastases.Patients receiving cytotoxic chemotherapy.Life-expectancy < 6 months.Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding or any other increased risk for bleeding (eg diabetic retinopathy).Body weight < 45 kg.Drug-or alcohol abuse.Related to current treatment Therapy with oral anticoagulants, heparins or factor Xa inhibitors other than study medication are not allowed.Therapy with platelet aggregation inhibitors must be stopped prior to randomization. Patients where continued treatment with platelet aggregation inhibitors is clinically indicated will be excluded. The therapy with acetylicsalicylic acid at daily doses up to 500 mg/d is allowed during the study and prior to randomization. Any treatment prior to randomization with heparins (exception: unfractionated heparin treatment within 36 hours, 2 therapeutic doses of a LMWH 24 hours apart or 3 therapeutic doses of a LMWH 12 hours apart. Prophylactic doses of UFH or LMWH are allowed).Fibrinolytic agents are not allowed during the study.All other drugs influencing coagulation (exception: NSAIDs with half-life < 17 hours) are not allowed during the study.Systemic and local topical treatment with azole compounds and other strong CYP3A4 inhibitors are not allowed 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)
The packaging is such, that the different BAY 59 7939 dose arms appear identical. An interactive voice response system (IVRS) is used to accomplish a blind allocation.
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
1/03/2004
Actual
24/03/2004
Date of last participant enrolment
Anticipated
Actual
10/06/2005
Date of last data collection
Anticipated
Actual
5/10/2005
Sample size
Target
600
Accrual to date
Final
613
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 894 0
Commercial sector/Industry
Name [1] 894 0
Bayer Australia Ltd
Country [1] 894 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] 756 0
None
Name [1] 756 0
NA
Address [1] 756 0
Country [1] 756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305289 0
Comitato Etico Aziende Sanitarie Umbria
Ethics committee address [1] 305289 0
Ethics committee country [1] 305289 0
Italy
Date submitted for ethics approval [1] 305289 0
17/11/2003
Approval date [1] 305289 0
11/12/2003
Ethics approval number [1] 305289 0

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

Contacts
Principal investigator
Name 35307 0
Address 35307 0
Country 35307 0
Phone 35307 0
Fax 35307 0
Email 35307 0
Contact person for public queries
Name 9888 0
Clinical Research Manager
Address 9888 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 9888 0
Australia
Phone 9888 0
+61 2 93916140
Fax 9888 0
Email 9888 0
@bayerhealthcare.com
Contact person for scientific queries
Name 816 0
Medical Services Manager
Address 816 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 816 0
Australia
Phone 816 0
+61 2 93916147
Fax 816 0
Email 816 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.