ThromboembolismPhase 3NCT00168818

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

A Phase 3 study testing dabigatran etexilate and enoxaparin in people with Thromboembolism and Arthroplasty, Replacement, Hip, run by Boehringer Ingelheim at 116 sites in 16 countries.

Completed

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

Official record

Search all trials

Trial summary

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thromboembolism, Arthroplasty, Replacement, Hip
What is being tested?: dabigatran etexilate and enoxaparin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,494 participants
Where: 116 sitesin 16 countries
Study dates: Nov 2004to Jul 2006
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 (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
Written Informed Consent

Who cannot join

Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
Active malignant disease or current cytostatic treatment
Known severe renal insufficiency
Liver disease expected to have any potential impact on survival, or elevated AST or ALT > 2x upper limit of normal
Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control

Show all 9Show fewer

Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
Contraindications to enoxaparin
Participation in a clinical trial during the last 30 days

Trial locations and contacts

116 sites in 16 countries.

Country

City, postcode or hospital

116 sites in 16 countries

Poland12 sites

1160.48.04810 Boehringer Ingelheim Investigational Site
Bialystok
1160.48.04804 Boehringer Ingelheim Investigational Site
Kielce
1160.48.04806 Boehringer Ingelheim Investigational Site
Krakow
1160.48.04807 Boehringer Ingelheim Investigational Site
Krakow
1160.48.04812 Boehringer Ingelheim Investigational Site
Krakow
1160.48.04820 Boehringer Ingelheim Investigational Site
Lodz
1160.48.04814 Boehringer Ingelheim Investigational Site
Mielec
1160.48.04808 Boehringer Ingelheim Investigational Site
Piekary Śląskie
1160.48.04817 Boehringer Ingelheim Investigational Site
Rzeszów
1160.48.04801 Boehringer Ingelheim Investigational Site
Warsaw
1160.48.04802 Boehringer Ingelheim Investigational Site
Warsaw
1160.48.04803 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Germany11 sites

1160.48.04906 Caritaskrankenhaus
Bad Mergentheim
1160.48.04910 F.-A.-Universität Erlangen-Nürnberg
Erlangen
1160.48.04904 Orthopädische Universitätsklinik
Frankfurt
1160.48.04902 Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen
1160.48.04914 St. Bernhard-Hospital
Kamp-Lintfort
1160.48.04907 Johannes Gutenberg-Universität Mainz
Mainz
1160.48.04912 Orthopädische Klinik Markgröningen gGmbH
Markgröningen
1160.48.04901 Kreiskrankenhaus
Rheinfelden
1160.48.04915 Orthopädische Klinik Lindenlohe
Schwandorf in Bayern
1160.48.04903 Hellmuth-Ulrici-Kliniken
Sommerfeld
1160.48.04905 Aukammklinik
Wiesbaden

Other trials in Germany

Spain11 sites

1160.48.03405 Boehringer Ingelheim Investigational Site
Alcorcón (Madrid)
1160.48.03403 Boehringer Ingelheim Investigational Site
Barcelona
1160.48.03411 Boehringer Ingelheim Investigational Site
Barcelona
1160.48.03407 Boehringer Ingelheim Investigational Site
Hospitalet (Barcelona)
1160.48.03409 Boehringer Ingelheim Investigational Site
Jaén
1160.48.03401 Boehringer Ingelheim Investigational Site
Madrid
1160.48.03402 Boehringer Ingelheim Investigational Site
Madrid
1160.48.03404 Boehringer Ingelheim Investigational Site
Madrid
1160.48.03406 Boehringer Ingelheim Investigational Site
Madrid
1160.48.03408 Boehringer Ingelheim Investigational Site
Móstoles (Madrid)
1160.48.03410 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Australia10 sites

1160.48.06105 Flinders Medical Centre
Bedford Park, South Australia
1160.48.06104 Ecru
Box Hill, Victoria
1160.48.06102 Monash Medical Centre
Clayton, Victoria
1160.48.06108 Canberra Hospital
Garren, Australian Capital Territory
1160.48.06106 St George Public Hospital
Kogarah, New South Wales
1160.48.06110 Suite 13 level 4
Lismore, New South Wales
1160.48.06101 Emeritus Research
Malvern, Victoria
1160.48.06111 Haemophillia & Thrombosis Service
Perth, Western Australia
1160.48.06103 Maroondah Hospital
Ringwood East, Victoria
1160.48.06113
Windsor, Victoria

Other trials in Australia

Czechia10 sites

1160.48.42004 Boehringer Ingelheim Investigational Site
Brno-Bohunice
1160.48.42010 Boehringer Ingelheim Investigational Site
Chomutov
1160.48.42009 Boehringer Ingelheim Investigational Site
Havlíčkův Brod
1160.48.42008 Boehringer Ingelheim Investigational Site
Jihlava
1160.48.42002 Boehringer Ingelheim Investigational Site
Kladno
1160.48.42006 Boehringer Ingelheim Investigational Site
Kolín
1160.48.42003 Boehringer Ingelheim Investigational Site
Ostrava
1160.48.42001 Boehringer Ingelheim Investigational Site
Pilsen
1160.48.42007 Boehringer Ingelheim Investigational Site
Pradubice
1160.48.42005 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Sweden10 sites

1160.48.04602 Boehringer Ingelheim Investigational Site
Falköping
1160.48.04601 Boehringer Ingelheim Investigational Site
Gothenburg
1160.48.04607 Boehringer Ingelheim Investigational Site
Halmstad
1160.48.04606 Boehringer Ingelheim Investigational Site
Kalmar
1160.48.04603 Boehringer Ingelheim Investigational Site
Kungälv
1160.48.04608 Boehringer Ingelheim Investigational Site
Lidköping
1160.48.04605 Boehringer Ingelheim Investigational Site
Linköping
1160.48.04604 Boehringer Ingelheim Investigational Site
Mölndal
1160.48.04610 Boehringer Ingelheim Investigational Site
Stockholm
1160.48.04609 Boehringer Ingelheim Investigational Site
Varberg

Other trials in Sweden

Belgium7 sites

1160.48.03207 UVC Brugmann
Brussels
1160.48.03206 Campus Sint-Lucas
Ghent
1160.48.03208 UZ Gent
Ghent
1160.48.03202 Boehringer Ingelheim Investigational Site
Hasselt
1160.48.03203 AZ Sint Elisabeth
Herentals
1160.48.03205 Ziekenhuis Oost-Limburg
Lanaken
1160.48.03201 UZ Gasthuisberg
Leuven

Other trials in Belgium

Hungary7 sites

1160.48.03607 Boehringer Ingelheim Investigational Site
Békéscsaba
1160.48.03603 Boehringer Ingelheim Investigational Site
Budapest
1160.48.03606 Boehringer Ingelheim Investigational Site
Budapest
1160.48.03601 Boehringer Ingelheim Investigational Site
Gyula
1160.48.03604 Boehringer Ingelheim Investigational Site
Kecskemét
1160.48.03602 Boehringer Ingelheim Investigational Site
Szeged
1160.48.03605 Boehringer Ingelheim Investigational Site
Székesfehérvár

Other trials in Hungary

Netherlands6 sites

1160.48.03102 Boehringer Ingelheim Investigational Site
Amsterdam
1160.48.03101 Boehringer Ingelheim Investigational Site
Heemstede
1160.48.03107 Boehringer Ingelheim Investigational Site
Helmond
1160.48.03103 Boehringer Ingelheim Investigational Site
Hilversum
1160.48.03104 Boehringer Ingelheim Investigational Site
Nijmegen
1160.48.03105 Boehringer Ingelheim Investigational Site
Sittard

Other trials in Netherlands

Norway6 sites

1160.48.04703 Boehringer Ingelheim Investigational Site
Ålesund
1160.48.04704 Boehringer Ingelheim Investigational Site
Bærum Postterminal
1160.48.04707 Boehringer Ingelheim Investigational Site
Bærum Postterminal
1160.48.04701 Boehringer Ingelheim Investigational Site
Bodø
1160.48.04706 Boehringer Ingelheim Investigational Site
Elverum
1160.48.04702 Boehringer Ingelheim Investigational Site
Skien

Other trials in Norway

Denmark5 sites

1160.48.04571 Boehringer Ingelheim Investigational Site
Hellerup
1160.48.04570 Boehringer Ingelheim Investigational Site
Hørsholm
1160.48.04573 Boehringer Ingelheim Investigational Site
København NV
1160.48.04574 Boehringer Ingelheim Investigational Site
København S
1160.48.04575 Boehringer Ingelheim Investigational Site
Silkeborg

Other trials in Denmark

Finland5 sites

1160.48.35803 Boehringer Ingelheim Investigational Site
Helsinki
1160.48.35802 Boehringer Ingelheim Investigational Site
Jyväskylä
1160.48.35801 Boehringer Ingelheim Investigational Site
Oulu
1160.48.35804 Boehringer Ingelheim Investigational Site
Seinäjoki
1160.48.35805 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Austria4 sites

1160.48.04304 Boehringer Ingelheim Investigational Site
Linz
1160.48.04302 Boehringer Ingelheim Investigational Site
Vienna
1160.48.04303 Boehringer Ingelheim Investigational Site
Wels
1160.48.04301 Boehringer Ingelheim Investigational Site
Wiener Neustadt

Other trials in Austria

France4 sites

1160.48.03304 Boehringer Ingelheim Investigational Site
Amiens
1160.48.03303 Boehringer Ingelheim Investigational Site
Roubaix
1160.48.03302 Boehringer Ingelheim Investigational Site
Soyaux
1160.48.03308 Boehringer Ingelheim Investigational Site
Strasbourg

Other trials in France

Italy4 sites

1160.48.03903 Boehringer Ingelheim Investigational Site
Bergamo
1160.48.03904 Boehringer Ingelheim Investigational Site
Bologna
1160.48.03902 Boehringer Ingelheim Investigational Site
Milan
1160.48.03901 Boehringer Ingelheim Investigational Site
Pavia

Other trials in Italy

South Africa4 sites

1160.48.02701 Boehringer Ingelheim Investigational Site
Bryanston
1160.48.02704 Boehringer Ingelheim Investigational Site
Johannesburg
1160.48.02703 Boehringer Ingelheim Investigational Site
Randburg
1160.48.02702 Boehringer Ingelheim Investigational Site
Sandton

Other trials in South Africa

About this study

Official title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)

Conditions: Thromboembolism, Arthroplasty, Replacement, Hip
Being tested: dabigatran etexilate, enoxaparin
Medical subject headings: Thromboembolism

What participants receive

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

dabigatran etexilateDrug
daily dose 150 mg once daily, half a dose on the day of surgery
dabigatran etexilateDrug
daily dose 150 mg once daily, half a dose on the day of surgery
enoxaparinDrug
40 mg once daily

Study groups in NCT00168818
Study group	Role	What they receive
dabigatran etexilate 75 mg	Experimental	daily dose 150 mg once daily, half a dose on the day of surgery Receives: Drug: dabigatran etexilate
dabigatran etexilate 110 mg	Experimental	daily dose 220 mg once daily, half a dose on the day of surgery Receives: Drug: dabigatran etexilate
enoxaparin	Active comparator	40 mg once daily Receives: Drug: enoxaparin

What is being measured

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

Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
Measured: First administration until 31-38 days

Secondary outcomes (11)

Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Measured: First administration until 31-38 days
Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Measured: First administration until 31-38 days
Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Measured: First administration until 31-38 days
Symptomatic Deep Vein Thrombosis During Treatment Period
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Measured: First administration until 31-38 days
Pulmonary Embolism During Treatment Period
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Measured: First administration until 31-38 days
Death During Treatment Period
All cause death, as adjudicated by the VTE events committee
Measured: First administration until 31-38 days
Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Measured: end of treatment to day 91±7
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Major bleeding events were defined as
- fatal
- clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
- clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
- symptomatic retroperitoneal, intracranial, intraocular or intraspinal
- requiring treatment cessation
- leading to re-operation
Clinically-relevant was defined as
- spontaneous skin hematoma greater than or equal to 25 cm²
- wound hematoma greater than or equal to 100 cm²
- spontaneous nose bleed lasting longer than 5 min
- macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
- spontaneous rectal bleeding (more than a spot on toilet paper)
- gingival bleeding lasting longer than 5 min
- any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Measured: First administration until 31-38 days
Blood Transfusion
Blood transfusion for treated and operated patients on Day of surgery.
Measured: Day 1
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Measured: Day 1
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.
Measured: First administration to end of study

Timeline

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

Nov 2004Jul 2006

First posted15 Sep 2005 (estimated)
Study startNov 2004
Primary completionJul 2006

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 (4)Papers the sponsor has linked to this study.
Other trials for 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: 3,494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00168818
Sponsor's protocol ID: 1160.48
Other IDs: 2004-001988-21, 2004
Status last verified: Feb 2014
First submitted: 12 Sep 2005
Last updated: 19 May 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.
PubMed 26578849
Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.
PubMed 22995531
Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.
PubMed 22709460
Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Buller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. doi: 10.1016/S0140-6736(07)61445-7.
PubMed 17869635

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
ClinicalTrials.gov ID: NCT00168818
Acronym / sponsor ID: 1160.48
Conditions: Thromboembolism, Arthroplasty, Replacement, Hip
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,494 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Jul 2006 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 20 Dec 2010

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: 3

Arm	Type	Receives
dabigatran etexilate 75 mg	Experimental	Drug: dabigatran etexilatedaily dose 150 mg once daily, half a dose on the day of surgery
dabigatran etexilate 110 mg	Experimental	Drug: dabigatran etexilatedaily dose 220 mg once daily, half a dose on the day of surgery
enoxaparin	Active comparator	Drug: enoxaparin40 mg once 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 (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
Written Informed Consent

Key exclusion criteria (9 listed)

Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
Active malignant disease or current cytostatic treatment
Known severe renal insufficiency
Liver disease expected to have any potential impact on survival, or elevated AST or ALT > 2x upper limit of normal
Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months

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 etexilatedaily dose 150 mg once daily, half a dose on the day of surgery	Drug	dabigatran etexilate 75 mg
dabigatran etexilatedaily dose 150 mg once daily, half a dose on the day of surgery	Drug	dabigatran etexilate 110 mg
enoxaparin40 mg once daily	Drug	enoxaparin

Primary outcome

Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Time frame: First administration until 31-38 days
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.

11 secondary outcomes

Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Time frame: First administration until 31-38 days
Proximal Deep Vein Thrombosis During Treatment Period
Time frame: First administration until 31-38 days
Total Deep Vein Thrombosis During Treatment Period
Time frame: First administration until 31-38 days
Symptomatic Deep Vein Thrombosis During Treatment Period
Time frame: First administration until 31-38 days
Pulmonary Embolism During Treatment Period
Time frame: First administration until 31-38 days
Death During Treatment Period
Time frame: First administration until 31-38 days
Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Time frame: end of treatment to day 91±7
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Time frame: First administration until 31-38 days
Blood Transfusion
Time frame: Day 1
Volume of Blood Loss
Time frame: Day 1
Laboratory Analyses
Time frame: First administration to end of study

Results and safety

Results posted to the registry on 20 Dec 2010, 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 220mg	1,146	1,029
Dabigatran 150mg	1,163	1,054
Enoxaparin	1,154	1,030

Primary outcome: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Time frame: First administration until 31-38 days. Number. Unit: Participants

Measure	Dabigatran 220mg n = 880	Dabigatran 150mg n = 874	Enoxaparin n = 897
Value	53	75	60

Dabigatran 220mg vs Enoxaparin: Risk Difference (Percentage): -0.7 (95% CI -2.9 to 1.6), p = 0.5648, Normal approximation
Dabigatran 150mg vs Enoxaparin: Risk Difference (Percentage): 1.9 (95% CI -0.6 to 4.4), p = 0.1339, Normal approximation

Population analysed: Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran 220mg	89 of 1,146 (7.8%)	620 of 1,146 (54.1%)	Not reported
Dabigatran 150mg	91 of 1,163 (7.8%)	642 of 1,163 (55.2%)	Not reported
Enoxaparin	82 of 1,154 (7.1%)	648 of 1,154 (56.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26578849Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.
Derived from this study: PubMed 22995531Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.
Derived from this study: PubMed 22709460Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.
Derived from this study: PubMed 17869635Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Buller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. doi: 10.1016/S0140-6736(07)61445-7.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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

116 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dabigatran etexilate and enoxaparin in people with Thromboembolism and Arthroplasty, Replacement, Hip, run by Boehringer Ingelheim at 116 sites in 16 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 9 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Poland, Germany, Spain, Australia, Czechia and 11 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. 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 20 Dec 2010). 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?

Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (time frame: First administration until 31-38 days). 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 NCT00168818, which also lists 4 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 19 May 2014.