Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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.
Query!
Secondary ID [1]
0
0
2007-002586-12
Query!
Secondary ID [2]
0
0
1160.63
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RE-SONATE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
6 months
Query!
Secondary outcome [1]
0
0
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
6 months
Query!
Secondary outcome [2]
0
0
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Query!
Assessment method [2]
0
0
Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Query!
Timepoint [2]
0
0
6 months
Query!
Secondary outcome [3]
0
0
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Query!
Assessment method [3]
0
0
Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Query!
Timepoint [3]
0
0
6 months
Query!
Secondary outcome [4]
0
0
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Query!
Assessment method [4]
0
0
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Query!
Timepoint [4]
0
0
6 months
Query!
Secondary outcome [5]
0
0
Centrally Confirmed Bleeding Event During the Treatment Period
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
6 months
Query!
Secondary outcome [6]
0
0
Centrally Confirmed Cardiovascular Events During the Treatment Period
Query!
Assessment method [6]
0
0
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Query!
Timepoint [6]
0
0
6 months
Query!
Secondary outcome [7]
0
0
Laboratory Measures, Especially Liver Function Tests (LFTs)
Query!
Assessment method [7]
0
0
Number of participants with possible clinically significant abnormalities during the treatment period.
Query!
Timepoint [7]
0
0
6 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1353
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
1160.63.61002 Boehringer Ingelheim Investigational Site - Greenslopes
Query!
Recruitment hospital [2]
0
0
1160.63.61003 Boehringer Ingelheim Investigational Site - Elizabeth Vale
Query!
Recruitment hospital [3]
0
0
1160.63.61001 Boehringer Ingelheim Investigational Site - Clayton
Query!
Recruitment hospital [4]
0
0
1160.63.61004 Boehringer Ingelheim Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
- Greenslopes
Query!
Recruitment postcode(s) [2]
0
0
- Elizabeth Vale
Query!
Recruitment postcode(s) [3]
0
0
- Clayton
Query!
Recruitment postcode(s) [4]
0
0
- Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maine
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Montana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Virginia
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Washington
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Graz
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Innsbruck
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Wien
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Aalst
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Duffel
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Kortrijk
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Leuven
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Lier
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Alberta
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
New Brunswick
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
Czech Republic
Query!
State/province [29]
0
0
Ceske Budejovice
Query!
Country [30]
0
0
Czech Republic
Query!
State/province [30]
0
0
Jablonec nad Nisou
Query!
Country [31]
0
0
Czech Republic
Query!
State/province [31]
0
0
Kladno
Query!
Country [32]
0
0
Czech Republic
Query!
State/province [32]
0
0
Liberec
Query!
Country [33]
0
0
Czech Republic
Query!
State/province [33]
0
0
Nymburk
Query!
Country [34]
0
0
Czech Republic
Query!
State/province [34]
0
0
Ostrava-Vitkovice
Query!
Country [35]
0
0
Czech Republic
Query!
State/province [35]
0
0
Ostrava
Query!
Country [36]
0
0
Czech Republic
Query!
State/province [36]
0
0
Prague 4-Krc
Query!
Country [37]
0
0
Czech Republic
Query!
State/province [37]
0
0
Prague 4
Query!
Country [38]
0
0
Czech Republic
Query!
State/province [38]
0
0
Praha 4
Query!
Country [39]
0
0
Czech Republic
Query!
State/province [39]
0
0
Prostejov
Query!
Country [40]
0
0
Czech Republic
Query!
State/province [40]
0
0
Rakovnik
Query!
Country [41]
0
0
Czech Republic
Query!
State/province [41]
0
0
Slany
Query!
Country [42]
0
0
Czech Republic
Query!
State/province [42]
0
0
Tabor
Query!
Country [43]
0
0
Estonia
Query!
State/province [43]
0
0
Kohtla-Järve
Query!
Country [44]
0
0
Estonia
Query!
State/province [44]
0
0
Tallin
Query!
Country [45]
0
0
Estonia
Query!
State/province [45]
0
0
Tartu
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Darmstadt
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Dresden
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Gießen
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Ludwigshafen
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Mannheim
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
München
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Püttlingen
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Bergamo
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Castelfranco Veneto (TV)
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Chieti Scalo (CH)
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Cosenza
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Fidenza (PR)
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Firenze
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Genova
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Milano
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Napoli
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Palermo
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Pisa
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Rimini
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Roma
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Treviso
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Udine
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Vittorio veneto (TV)
Query!
Country [69]
0
0
Korea, Republic of
Query!
State/province [69]
0
0
Gwangju-si
Query!
Country [70]
0
0
Korea, Republic of
Query!
State/province [70]
0
0
Incheon
Query!
Country [71]
0
0
Korea, Republic of
Query!
State/province [71]
0
0
Kyeonggi-do
Query!
Country [72]
0
0
Korea, Republic of
Query!
State/province [72]
0
0
Kyunggi-do
Query!
Country [73]
0
0
Korea, Republic of
Query!
State/province [73]
0
0
Seoul
Query!
Country [74]
0
0
Korea, Republic of
Query!
State/province [74]
0
0
Suwon
Query!
Country [75]
0
0
Latvia
Query!
State/province [75]
0
0
Daugavpils
Query!
Country [76]
0
0
Latvia
Query!
State/province [76]
0
0
Riga
Query!
Country [77]
0
0
Lithuania
Query!
State/province [77]
0
0
Kaunas
Query!
Country [78]
0
0
Lithuania
Query!
State/province [78]
0
0
Vilnius
Query!
Country [79]
0
0
Netherlands
Query!
State/province [79]
0
0
Assen
Query!
Country [80]
0
0
Netherlands
Query!
State/province [80]
0
0
Breda
Query!
Country [81]
0
0
Netherlands
Query!
State/province [81]
0
0
Den Haag
Query!
Country [82]
0
0
Netherlands
Query!
State/province [82]
0
0
Den Helder
Query!
Country [83]
0
0
Netherlands
Query!
State/province [83]
0
0
Dirksland
Query!
Country [84]
0
0
Netherlands
Query!
State/province [84]
0
0
Eindhoven
Query!
Country [85]
0
0
Netherlands
Query!
State/province [85]
0
0
Groningen
Query!
Country [86]
0
0
Netherlands
Query!
State/province [86]
0
0
Heerlen
Query!
Country [87]
0
0
Netherlands
Query!
State/province [87]
0
0
Oss
Query!
Country [88]
0
0
New Zealand
Query!
State/province [88]
0
0
Christchurch
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Kielce
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Poznan
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Warsaw
Query!
Country [92]
0
0
Russian Federation
Query!
State/province [92]
0
0
Ekaterinburg
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Kursk
Query!
Country [94]
0
0
Russian Federation
Query!
State/province [94]
0
0
Ufa
Query!
Country [95]
0
0
Russian Federation
Query!
State/province [95]
0
0
Yaroslavl
Query!
Country [96]
0
0
Singapore
Query!
State/province [96]
0
0
Singapore
Query!
Country [97]
0
0
South Africa
Query!
State/province [97]
0
0
Cape Town
Query!
Country [98]
0
0
South Africa
Query!
State/province [98]
0
0
Centurion
Query!
Country [99]
0
0
South Africa
Query!
State/province [99]
0
0
Krugersdorp
Query!
Country [100]
0
0
South Africa
Query!
State/province [100]
0
0
Somerset West
Query!
Country [101]
0
0
Sweden
Query!
State/province [101]
0
0
Göteborg
Query!
Country [102]
0
0
Sweden
Query!
State/province [102]
0
0
Lund
Query!
Country [103]
0
0
Sweden
Query!
State/province [103]
0
0
Mölndal
Query!
Country [104]
0
0
Sweden
Query!
State/province [104]
0
0
Skövde
Query!
Country [105]
0
0
Sweden
Query!
State/province [105]
0
0
Stockholm
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Värnamo
Query!
Country [107]
0
0
Switzerland
Query!
State/province [107]
0
0
Basel
Query!
Country [108]
0
0
Switzerland
Query!
State/province [108]
0
0
Bruderholz
Query!
Country [109]
0
0
Switzerland
Query!
State/province [109]
0
0
Cham
Query!
Country [110]
0
0
Switzerland
Query!
State/province [110]
0
0
Glarus
Query!
Country [111]
0
0
Switzerland
Query!
State/province [111]
0
0
Luzern 16
Query!
Country [112]
0
0
Switzerland
Query!
State/province [112]
0
0
Luzern
Query!
Country [113]
0
0
Switzerland
Query!
State/province [113]
0
0
Schiers
Query!
Country [114]
0
0
Switzerland
Query!
State/province [114]
0
0
Thun
Query!
Country [115]
0
0
Switzerland
Query!
State/province [115]
0
0
Wetzikon
Query!
Country [116]
0
0
Switzerland
Query!
State/province [116]
0
0
Zug
Query!
Country [117]
0
0
Switzerland
Query!
State/province [117]
0
0
Zurich
Query!
Country [118]
0
0
Thailand
Query!
State/province [118]
0
0
Bangkok
Query!
Country [119]
0
0
Thailand
Query!
State/province [119]
0
0
Chiang Mai
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT00558259
Query!
Trial related presentations / publications
Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30. Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00558259
Download to PDF