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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00558259




Registration number
NCT00558259
Ethics application status
Date submitted
13/11/2007
Date registered
14/11/2007
Date last updated
27/06/2014

Titles & IDs
Public title
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
Scientific title
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
Secondary ID [1] 0 0
2007-002586-12
Secondary ID [2] 0 0
1160.63
Universal Trial Number (UTN)
Trial acronym
RE-SONATE
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
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dabigatran etexilate 150 mg twice daily (BID)
Treatment: Drugs - matching placebo twice daily (BID)

Experimental: dabigatran etexilate 150 mg BID - Patient to receive dabigatran etexilatate capsules 150 mg twice daily

Placebo Comparator: matching placebo twice daily (BID) - Patient to receive dabigatran extexilate matching placebo capsules twice daily


Treatment: Drugs: dabigatran etexilate 150 mg twice daily (BID)
dabigatran etexilate capsules 150 mg BID

Treatment: Drugs: matching placebo twice daily (BID)
Matching placebo BID

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

Outcomes
Primary outcome [1] 0 0
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period - Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period - Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period - Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period - Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period - Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Centrally Confirmed Bleeding Event During the Treatment Period - Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:
Fatal bleeding
Associated with a fall in haemoglobin of =2 g/dL
Led to the transfusion of =2 units packed cells or whole blood
Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal
Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.
Examples of these bleedings were:
Bleeding that compromised haemodynamics
Bleeding that led to hospitalisation
Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.
All bleeding events include MBEs, CRBEs, and trivial bleeding events.
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Centrally Confirmed Cardiovascular Events During the Treatment Period - Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Laboratory Measures, Especially Liver Function Tests (LFTs) - Number of participants with possible clinically significant abnormalities during the treatment period.
Timepoint [7] 0 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been
treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an
oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER
study medication up to the moment of screening for the current study.

2. Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Younger then 18 years of age

2. Indication for VKA other than DVT and/or PE

3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued

4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis,
chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN

5. Creatinine clearance < 30 ml/min

6. Acute bacterial endocarditis

7. Active bleeding or high risk for bleeding.

8. Uncontrolled hypertension (investigators judgement)

9. Intake of another experimental drug within the 30 days prior to randomization into the
study

10. Life expectancy <6 months

11. Childbearing potential without proper contraceptive measures*, pregnancy or breast
feeding

Study design
Purpose of the study
Prevention
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
1160.63.61002 Boehringer Ingelheim Investigational Site - Greenslopes
Recruitment hospital [2] 0 0
1160.63.61003 Boehringer Ingelheim Investigational Site - Elizabeth Vale
Recruitment hospital [3] 0 0
1160.63.61001 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [4] 0 0
1160.63.61004 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Greenslopes
Recruitment postcode(s) [2] 0 0
- Elizabeth Vale
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Thailand
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Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to
placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in
patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed
6 to 18 months of treatment with vitamin K antagonist (VKA).
Trial website
https://clinicaltrials.gov/show/NCT00558259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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