Venous ThromboembolismPhase 3RE-SONATENCT00558259

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

A Phase 3 study testing dabigatran etexilate 150 mg twice daily (BID) in people with Venous Thromboembolism, run by Boehringer Ingelheim at 147 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Thromboembolism
What is being tested?: dabigatran etexilate 150 mg twice daily (BID)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,353 participants
Where: 147 sitesin 21 countries
Study dates: Nov 2007to Feb 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Written informed consent

Who cannot join

Younger then 18 years of age
Indication for VKA other than DVT and/or PE
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
Creatinine clearance < 30 ml/min
Acute bacterial endocarditis

Show all 11Show fewer

Active bleeding or high risk for bleeding.
Uncontrolled hypertension (investigators judgement)
Intake of another experimental drug within the 30 days prior to randomization into the study
Life expectancy <6 months
Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding

Trial locations and contacts

147 sites in 21 countries.

Country

City, postcode or hospital

147 sites in 21 countries

United States21 sites

1160.63.01035 Boehringer Ingelheim Investigational Site
Bellevue, Washington
1160.63.01017 Boehringer Ingelheim Investigational Site
Biddeford, Maine
1160.63.01025 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1160.63.01005 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1160.63.01014 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1160.63.01032 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1160.63.01023 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1160.63.01003 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1160.63.01030 Boehringer Ingelheim Investigational Site
Key West, Florida
1160.63.01022 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
1160.63.01002 Boehringer Ingelheim Investigational Site
Laguna Hills, California
1160.63.01019 Boehringer Ingelheim Investigational Site
Missoula, Montana
1160.63.01044 Boehringer Ingelheim Investigational Site
New Iberia, Louisiana
1160.63.01007 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1160.63.01004 Boehringer Ingelheim Investigational Site
Salisbury, Maryland
1160.63.01011 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1160.63.01020 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1160.63.01037 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1160.63.01001 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1160.63.01024 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1160.63.01016 Boehringer Ingelheim Investigational Site
Worcester, Massachusetts

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Italy18 sites

1160.63.39006 Boehringer Ingelheim Investigational Site
Bergamo
1160.63.39015 Boehringer Ingelheim Investigational Site
Castelfranco Veneto (TV)
1160.63.39019 Boehringer Ingelheim Investigational Site
Chieti Scalo (CH)
1160.63.39003 Boehringer Ingelheim Investigational Site
Cosenza
1160.63.39008 Boehringer Ingelheim Investigational Site
Fidenza (PR)
1160.63.39011 Boehringer Ingelheim Investigational Site
Florence
1160.63.39009 Boehringer Ingelheim Investigational Site
Genova
1160.63.39004 Boehringer Ingelheim Investigational Site
Milan
1160.63.39010 Boehringer Ingelheim Investigational Site
Milan
1160.63.39020 Boehringer Ingelheim Investigational Site
Milan
1160.63.39022 Boehringer Ingelheim Investigational Site
Naples
1160.63.39001 Boehringer Ingelheim Investigational Site
Palermo
1160.63.39007 Boehringer Ingelheim Investigational Site
Pisa
1160.63.39012 Boehringer Ingelheim Investigational Site
Rimini
1160.63.39017 Boehringer Ingelheim Investigational Site
Roma
1160.63.39014 Boehringer Ingelheim Investigational Site
Treviso
1160.63.39002 Boehringer Ingelheim Investigational Site
Udine
1160.63.39016 Boehringer Ingelheim Investigational Site
Vittorio Veneto (TV)

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Czechia14 sites

1160.63.42004 Boehringer Ingelheim Investigational Site
České Budějovice
1160.63.42003 Boehringer Ingelheim Investigational Site
Jablonec nad Nisou
1160.63.42008 Boehringer Ingelheim Investigational Site
Kladno
1160.63.42012 Boehringer Ingelheim Investigational Site
Liberec
1160.63.42010 Boehringer Ingelheim Investigational Site
Nymburk
1160.63.42009 Boehringer Ingelheim Investigational Site
Ostrava
1160.63.42011 Boehringer Ingelheim Investigational Site
Ostrava-Vitkovice
1160.63.42001 Boehringer Ingelheim Investigational Site
Prague
1160.63.42006 Boehringer Ingelheim Investigational Site
Prague
1160.63.42002 Boehringer Ingelheim Investigational Site
Prague 4-Krc
1160.63.42005 Boehringer Ingelheim Investigational Site
Prostějov
1160.63.42007 Boehringer Ingelheim Investigational Site
Rakovník
1160.63.42013 Boehringer Ingelheim Investigational Site
Slaný
1160.63.42014 Boehringer Ingelheim Investigational Site
Tábor

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Switzerland11 sites

1160.63.41012 Boehringer Ingelheim Investigational Site
Basel
1160.63.41011 Boehringer Ingelheim Investigational Site
Bruderholz
1160.63.41003 Boehringer Ingelheim Investigational Site
Cham
1160.63.41001 Boehringer Ingelheim Investigational Site
Glarus
1160.63.41014 Boehringer Ingelheim Investigational Site
Lucerne
1160.63.41016 Boehringer Ingelheim Investigational Site
Lucerne
1160.63.41005 Boehringer Ingelheim Investigational Site
Schiers
1160.63.41009 Boehringer Ingelheim Investigational Site
Thun
1160.63.41022 Boehringer Ingelheim Investigational Site
Wetzikon
1160.63.41008 Boehringer Ingelheim Investigational Site
Zug
1160.63.41006 Boehringer Ingelheim Investigational Site
Zurich

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Germany9 sites

1160.63.49013 Boehringer Ingelheim Investigational Site
Darmstadt
1160.63.49017 Boehringer Ingelheim Investigational Site
Dresden
1160.63.49018 Boehringer Ingelheim Investigational Site
Dresden
1160.63.49014 Boehringer Ingelheim Investigational Site
Giessen
1160.63.49011 Boehringer Ingelheim Investigational Site
Ludwigshafen
1160.63.49005 Boehringer Ingelheim Investigational Site
Mannheim
1160.63.49010 Boehringer Ingelheim Investigational Site
Mannheim
1160.63.49007 Boehringer Ingelheim Investigational Site
München
1160.63.49009 Boehringer Ingelheim Investigational Site
Püttlingen

Other trials in Germany

Netherlands9 sites

1160.63.31010 Boehringer Ingelheim Investigational Site
Assen
1160.63.31006 Boehringer Ingelheim Investigational Site
Breda
1160.63.31011 Boehringer Ingelheim Investigational Site
Den Helder
1160.63.31012 Boehringer Ingelheim Investigational Site
Dirksland
1160.63.31003 Boehringer Ingelheim Investigational Site
Eindhoven
1160.63.31001 Boehringer Ingelheim Investigational Site
Groningen
1160.63.31009 Boehringer Ingelheim Investigational Site
Heerlen
1160.63.31008 Boehringer Ingelheim Investigational Site
Oss
1160.63.31007 Boehringer Ingelheim Investigational Site
The Hague

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Poland9 sites

1160.63.48010 Boehringer Ingelheim Investigational Site
Kielce
1160.63.48003 Boehringer Ingelheim Investigational Site
Poznan
1160.63.48001 Boehringer Ingelheim Investigational Site
Warsaw
1160.63.48002 Boehringer Ingelheim Investigational Site
Warsaw
1160.63.48004 Boehringer Ingelheim Investigational Site
Warsaw
1160.63.48005 Boehringer Ingelheim Investigational Site
Warsaw
1160.63.48006 Boehringer Ingelheim Investigational Site
Warsaw
1160.63.48007 Boehringer Ingelheim Investigational Site
Warsaw
1160.63.48008 Boehringer Ingelheim Investigational Site
Warsaw

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South Korea9 sites

1160.63.82010 Boehringer Ingelheim Investigational Site
Gwangju
1160.63.82003 Boehringer Ingelheim Investigational Site
Incheon
1160.63.82005 Boehringer Ingelheim Investigational Site
Kyeonggi-do
1160.63.82001 Boehringer Ingelheim Investigational Site
Kyunggi-do
1160.63.82004 Boehringer Ingelheim Investigational Site
Seoul
1160.63.82006 Boehringer Ingelheim Investigational Site
Seoul
1160.63.82008 Boehringer Ingelheim Investigational Site
Seoul
1160.63.82011 Boehringer Ingelheim Investigational Site
Seoul
1160.63.82007 Boehringer Ingelheim Investigational Site
Suwon

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Sweden7 sites

1160.63.46001 Boehringer Ingelheim Investigational Site
Gothenburg
1160.63.46006 Boehringer Ingelheim Investigational Site
Gothenburg
1160.63.46002 Boehringer Ingelheim Investigational Site
Lund
1160.63.46004 Boehringer Ingelheim Investigational Site
Mölndal
1160.63.46007 Boehringer Ingelheim Investigational Site
Skövde
1160.63.46005 Boehringer Ingelheim Investigational Site
Stockholm
1160.63.46003 Boehringer Ingelheim Investigational Site
Värnamo

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Austria5 sites

1160.63.43005 Boehringer Ingelheim Investigational Site
Graz
1160.63.43006 Boehringer Ingelheim Investigational Site
Innsbruck
1160.63.43001 Boehringer Ingelheim Investigational Site
Vienna
1160.63.43002 Boehringer Ingelheim Investigational Site
Vienna
1160.63.43004 Boehringer Ingelheim Investigational Site
Vienna

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Belgium5 sites

1160.63.32005 Boehringer Ingelheim Investigational Site
Aalst
1160.63.32004 Boehringer Ingelheim Investigational Site
Duffel
1160.63.32003 Boehringer Ingelheim Investigational Site
Kortrijk
1160.63.32001 Boehringer Ingelheim Investigational Site
Leuven
1160.63.32002 Boehringer Ingelheim Investigational Site
Lier

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Russia5 sites

1160.63.07004 Boehringer Ingelheim Investigational Site
Kursk
1160.63.07014 Boehringer Ingelheim Investigational Site
Ufa
1160.63.07005 Boehringer Ingelheim Investigational Site
Yaroslavl
1160.63.07006 Boehringer Ingelheim Investigational Site
Yaroslavl
1160.63.07007 Boehringer Ingelheim Investigational Site
Yekaterinburg

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Australia4 sites

1160.63.61001 Boehringer Ingelheim Investigational Site
Clayton, Victoria
1160.63.61003 Boehringer Ingelheim Investigational Site
Elizabeth Vale, South Australia
1160.63.61002 Boehringer Ingelheim Investigational Site
Greenslopes, Queensland
1160.63.61004 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia

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Canada4 sites

1160.63.02013 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.63.02005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.63.02020 Boehringer Ingelheim Investigational Site
Québec, Quebec
1160.63.02004 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick

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South Africa4 sites

1160.63.27003 Boehringer Ingelheim Investigational Site
Cape Town
1160.63.27007 Boehringer Ingelheim Investigational Site
Centurion
1160.63.27009 Boehringer Ingelheim Investigational Site
Krugersdorp
1160.63.27001 Boehringer Ingelheim Investigational Site
Somerset West

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Thailand4 sites

1160.63.66002 Boehringer Ingelheim Investigational Site
Bangkok
1160.63.66003 Boehringer Ingelheim Investigational Site
Bangkok
1160.63.66004 Boehringer Ingelheim Investigational Site
Bangkok
1160.63.66001 Boehringer Ingelheim Investigational Site
Chiang Mai

Other trials in Thailand

Estonia3 sites

1160.63.37202 Boehringer Ingelheim Investigational Site
Kohtla-Järve
1160.63.37203 Boehringer Ingelheim Investigational Site
Tallinn
1160.63.37201 Boehringer Ingelheim Investigational Site
Tartu

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Latvia2 sites

1160.63.37101 Boehringer Ingelheim Investigational Site
Daugavpils
1160.63.37102 Boehringer Ingelheim Investigational Site
Riga

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Lithuania2 sites

1160.63.37002 Boehringer Ingelheim Investigational Site
Kaunas
1160.63.37001 Boehringer Ingelheim Investigational Site
Vilnius

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New Zealand1 site

1160.63.64002 Boehringer Ingelheim Investigational Site
Christchurch

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Singapore1 site

1160.63.65001 Boehringer Ingelheim Investigational Site
Singapore

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About this study

Official 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.

Conditions: Venous Thromboembolism
Being tested: dabigatran etexilate 150 mg twice daily (BID), matching placebo twice daily (BID)
Medical subject headings: Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dabigatran etexilate 150 mg twice daily (BID)Drug
dabigatran etexilate capsules 150 mg BID
matching placebo twice daily (BID)Drug
Matching placebo BID

Study groups in NCT00558259
Study group	Role	What they receive
dabigatran etexilate 150 mg BID	Experimental	Patient to receive dabigatran etexilatate capsules 150 mg twice daily Receives: Drug: dabigatran etexilate 150 mg twice daily (BID)
matching placebo twice daily (BID)	Placebo comparator	Patient to receive dabigatran extexilate matching placebo capsules twice daily Receives: Drug: matching placebo twice daily (BID)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (7)

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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Measured: 6 months
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.
Measured: 6 months
Centrally Confirmed Cardiovascular Events During the Treatment Period
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Measured: 6 months
Laboratory Measures, Especially Liver Function Tests (LFTs)
Number of participants with possible clinically significant abnormalities during the treatment period.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Feb 2011

First posted14 Nov 2007 (estimated)
Study startNov 2007
Primary completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,353 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558259
Sponsor's protocol ID: 1160.63
Other IDs: 2007-002586-12
Acronym: RE-SONATE
Status last verified: Feb 2014
First submitted: 13 Nov 2007
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 24081972
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.
PubMed 23425163

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT00558259
Acronym / sponsor ID: RE-SONATE / 1160.63
Conditions: Venous Thromboembolism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,353 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Feb 2011 (actual)
First posted: 14 Nov 2007 (estimated)
Results: Posted 2 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
dabigatran etexilate 150 mg BID	Experimental	Drug: dabigatran etexilate 150 mg twice daily (BID)Patient to receive dabigatran etexilatate capsules 150 mg twice daily
matching placebo twice daily (BID)	Placebo comparator	Drug: matching placebo twice daily (BID)Patient to receive dabigatran extexilate matching placebo capsules twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.
Written informed consent

Key exclusion criteria (11 listed)

Younger then 18 years of age
Indication for VKA other than DVT and/or PE
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
Creatinine clearance < 30 ml/min

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dabigatran etexilate 150 mg twice daily (BID)dabigatran etexilate capsules 150 mg BID	Drug	dabigatran etexilate 150 mg BID
matching placebo twice daily (BID)Matching placebo BID	Drug	matching placebo twice daily (BID)

Primary outcome

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Time frame: 6 months
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.

7 secondary outcomes

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Time frame: 6 months
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Time frame: 6 months
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Time frame: 6 months
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Time frame: 6 months
Centrally Confirmed Bleeding Event During the Treatment Period
Time frame: 6 months
Centrally Confirmed Cardiovascular Events During the Treatment Period
Time frame: 6 months
Laboratory Measures, Especially Liver Function Tests (LFTs)
Time frame: 6 months

Results and safety

Results posted to the registry on 2 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran	681	610
Placebo	662	563

Primary outcome: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period

Time frame: 6 months. Number. Unit: Participants

Measure	Dabigatran n = 681	Placebo n = 662
Value	3 (0.0)	37 (0.0)

Dabigatran vs Placebo: Hazard Ratio (HR): 0.08 (95% CI 0.02 to 0.25), p <0.0001, Regression, Cox

Population analysed: Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran	47 of 684 (6.9%)	0 of 684 (0%)	Not reported
Placebo	60 of 659 (9.1%)	0 of 659 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24081972Majeed 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.
Derived from this study: PubMed 23425163Schulman 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.
Related InfoLink provided by the sponsor.

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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

147 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dabigatran etexilate 150 mg twice daily (BID) in people with Venous Thromboembolism, run by Boehringer Ingelheim at 147 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Italy, Czechia, Switzerland, Germany and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558259, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.