Arthroplasty, Replacement, KneePhase 3NCT00168805

RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

A Phase 3 study testing enoxaparin and dabigatran etexilate in people with Arthroplasty, Replacement, Knee and Thromboembolism, run by Boehringer Ingelheim at 105 sites in 15 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Knee, Thromboembolism
What is being tested?: enoxaparin and dabigatran etexilate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,101 participants
Where: 105 sitesin 15 countries
Study dates: Nov 2004to May 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, elect ive total knee 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, arteriovenous (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 aspartate aminotransferase (AST) or alanine transaminase (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 pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control

Show all 9Show fewer

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

Trial locations and contacts

105 sites in 15 countries.

Country

City, postcode or hospital

105 sites in 15 countries

Australia12 sites

1160.25.06105 Boehringer Ingelheim Investigational Site
Bedford Park, South Australia
1160.25.06104 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
1160.25.06102 Boehringer Ingelheim Investigational Site
Clayton, Victoria
1160.25.06108 Boehringer Ingelheim Investigational Site
Garren, Australian Capital Territory
1160.25.06106 Boehringer Ingelheim Investigational Site
Kogarah, New South Wales
1160.25.06110 Boehringer Ingelheim Investigational Site
Lismore, New South Wales
1160.25.06101 Boehringer Ingelheim Investigational Site
Malvern, Victoria
1160.25.06111 Boehringer Ingelheim Investigational Site
Perth, Western Australia
1160.25.06103 Boehringer Ingelheim Investigational Site
Ringwood East, Victoria
1160.25.06107 Boehringer Ingelheim Investigational Site
Toorak Gardens, South Australia
1160.25.06113 Boehringer Ingelheim Investigational Site
Windsor, Victoria
1160.25.06109 Boehringer Ingelheim Investigational Site
Woodville, South Australia

Other trials in Australia

Spain11 sites

1160.25.03405 Boehringer Ingelheim Investigational Site
Alcorcón (Madrid)
1160.25.03403 Boehringer Ingelheim Investigational Site
Barcelona
1160.25.03411 Boehringer Ingelheim Investigational Site
Barcelona
1160.25.03407 Boehringer Ingelheim Investigational Site
Hospitalet (Barcelona)
1160.25.03409 Boehringer Ingelheim Investigational Site
Jaén
1160.25.03401 Boehringer Ingelheim Investigational Site
Madrid
1160.25.03402 Boehringer Ingelheim Investigational Site
Madrid
1160.25.03404 Boehringer Ingelheim Investigational Site
Madrid
1160.25.03406 Boehringer Ingelheim Investigational Site
Madrid
1160.25.03408 Boehringer Ingelheim Investigational Site
Móstoles (Madrid)
1160.25.03410 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Czechia9 sites

1160.25.42004 Boehringer Ingelheim Investigational Site
Brno-Bohunice
1160.25.42010 Boehringer Ingelheim Investigational Site
Chomutov
1160.25.42009 Boehringer Ingelheim Investigational Site
Havlíčkův Brod
1160.25.42002 Boehringer Ingelheim Investigational Site
Kladno
1160.25.42006 Boehringer Ingelheim Investigational Site
Kolín
1160.25.42003 Boehringer Ingelheim Investigational Site
Ostrava
1160.25.42001 Boehringer Ingelheim Investigational Site
Pilsen
1160.25.42007 Boehringer Ingelheim Investigational Site
Pradubice
1160.25.42005 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

France9 sites

1160.25.03304 Boehringer Ingelheim Investigational Site
Amiens
1160.25.03307 Boehringer Ingelheim Investigational Site
Annecy
1160.25.03305 Boehringer Ingelheim Investigational Site
La Rochelle
1160.25.03301 Boehringer Ingelheim Investigational Site
Paris
1160.25.03306 Boehringer Ingelheim Investigational Site
Poitiers
1160.25.03303 Boehringer Ingelheim Investigational Site
Roubaix
1160.25.03309 Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.25.03302 Boehringer Ingelheim Investigational Site
Soyaux
1160.25.03308 Boehringer Ingelheim Investigational Site
Strasbourg

Other trials in France

Germany9 sites

1160.25.04906 Caritaskrankenhaus
Bad Mergentheim
1160.25.04910 F.-A.-Universität Erlangen-Nürnberg
Erlangen
1160.25.04904 Orthopädische Universitätsklinik
Frankfurt
1160.25.04902 Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen
1160.25.04911 Martin-Luther-Universität Halle-Wittenberg
Halle
1160.25.04912 Orthopädische Klinik Markgröningen gGmbH
Markgröningen
1160.25.04901 Kreiskrankenhaus
Rheinfelden
1160.25.04903 Hellmuth-Ulrici-Kliniken
Sommerfeld
1160.25.04905 Aukammklinik
Wiesbaden

Other trials in Germany

Sweden9 sites

1160.25.04602 Boehringer Ingelheim Investigational Site
Falköping
1160.25.04601 Boehringer Ingelheim Investigational Site
Gothenburg
1160.25.04607 Boehringer Ingelheim Investigational Site
Halmstad
1160.25.04603 Boehringer Ingelheim Investigational Site
Kungälv
1160.25.04608 Boehringer Ingelheim Investigational Site
Lidköping
1160.25.04605 Boehringer Ingelheim Investigational Site
Linköping
1160.25.04604 Boehringer Ingelheim Investigational Site
Mölndal
1160.25.04610 Boehringer Ingelheim Investigational Site
Stockholm
1160.25.04609 Boehringer Ingelheim Investigational Site
Varberg

Other trials in Sweden

Belgium8 sites

1160.25.03207 UVC Brugmann
Brussels
1160.25.03209 ZOL St. Jan
Genk
1160.25.03206 Campus Sint-Lucas
Ghent
1160.25.03208 UZ Gent
Ghent
1160.25.03202 Virga Jesseziekenhuis
Hasselt
1160.25.03203 AZ Sint Elisabeth
Herentals
1160.25.03205 Ziekenhuis Oost-Limburg
Lanaken
1160.25.03201 UZ Gasthuisberg
Leuven

Other trials in Belgium

Hungary6 sites

1160.25.03607 Boehringer Ingelheim Investigational Site
Békéscsaba
1160.25.03603 Boehringer Ingelheim Investigational Site
Budapest
1160.25.03601 Boehringer Ingelheim Investigational Site
Gyula
1160.25.03604 Boehringer Ingelheim Investigational Site
Kecskemét
1160.25.03602 Boehringer Ingelheim Investigational Site
Szeged
1160.25.03605 Boehringer Ingelheim Investigational Site
Székesfehérvár

Other trials in Hungary

Italy6 sites

1160.25.03906 Boehringer Ingelheim Investigational Site
Bologna
1160.25.03905 Boehringer Ingelheim Investigational Site
Parma
1160.25.03901 Boehringer Ingelheim Investigational Site
Pavia
1160.25.03903 Boehringer Ingelheim Investigational Site
Piacenza
1160.25.03904 Boehringer Ingelheim Investigational Site
Reggio Emilia
1160.25.03902 Boehringer Ingelheim Investigational Site
Treviso

Other trials in Italy

Netherlands6 sites

1160.25.03102 Boehringer Ingelheim Investigational Site
Amsterdam
1160.25.03103 Boehringer Ingelheim Investigational Site
Hilversum
1160.25.03101 Boehringer Ingelheim Investigational Site
Hoofddorp
1160.25.03104 Boehringer Ingelheim Investigational Site
Nijmegen
1160.25.03105 Boehringer Ingelheim Investigational Site
Sittard
1160.25.03106 Boehringer Ingelheim Investigational Site
Zwolle

Other trials in Netherlands

Denmark5 sites

1160.25.04571 Boehringer Ingelheim Investigational Site
Hellerup
1160.25.04570 Boehringer Ingelheim Investigational Site
Hørsholm
1160.25.04573 Boehringer Ingelheim Investigational Site
København NV
1160.25.04574 Boehringer Ingelheim Investigational Site
København S
1160.25.04575 Boehringer Ingelheim Investigational Site
Silkeborg

Other trials in Denmark

Austria4 sites

1160.25.04304 Boehringer Ingelheim Investigational Site
Linz
1160.25.04302 Boehringer Ingelheim Investigational Site
Vienna
1160.25.04303 Boehringer Ingelheim Investigational Site
Wels
1160.25.04301 Boehringer Ingelheim Investigational Site
Wiener Neustadt

Other trials in Austria

Finland4 sites

1160.25.35803 Boehringer Ingelheim Investigational Site
Helsinki
1160.25.35802 Boehringer Ingelheim Investigational Site
Jyväskylä
1160.25.35801 Boehringer Ingelheim Investigational Site
Oulu
1160.25.35804 Boehringer Ingelheim Investigational Site
Seinäjoki

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Poland4 sites

1160.25.04804 Boehringer Ingelheim Investigational Site
Kielce
1160.25.04806 Boehringer Ingelheim Investigational Site
Krakow
1160.25.04807 Boehringer Ingelheim Investigational Site
Krakow
1160.25.04803 Boehringer Ingelheim Investigational Site
Warsaw

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South Africa3 sites

1160.25.02701 Boehringer Ingelheim Investigational Site
Bryanston
1160.25.02703 Boehringer Ingelheim Investigational Site
Randburg
1160.25.02702 Boehringer Ingelheim Investigational Site
Sandton

Other trials in South Africa

About this study

Official title: RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

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

What participants receive

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

enoxaparinDrug
40 mg once daily
dabigatran etexilateDrug
150 mg once daily
dabigatran etexilateDrug
220 mg once daily

Study groups in NCT00168805
Study group	Role	What they receive
dabigatran etexilate 220 mg	Experimental	220 mg once daily Receives: Drug: dabigatran etexilate
dabigatran etexilate 150 mg	Experimental	150 mg once daily 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.

Number of Participants With 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 6-10 days

Secondary outcomes (11)

Number of Participants With 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 6-10 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Measured: First administration until 6-10 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Measured: First administration until 6-10 days
Number of Participants With 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 6-10 days
Number of Participants With 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 6-10 days
Number of Participants Who Died During Treatment Period
All cause death, as adjudicated by the VTE events committee
Measured: First administration until 6-10 days
Number of Participants With 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: 3 months
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 6-10 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 2004May 2006

First posted15 Sep 2005 (estimated)
Study startNov 2004
Primary completionMay 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 (2)Papers the sponsor has linked to this study.
Other trials for Arthroplasty, Replacement, KneeStudies 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: 2,101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00168805
Sponsor's protocol ID: 1160.25
Other IDs: 2004-001317-34, 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, 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

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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SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
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ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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All Arthroplasty, Replacement, Knee trials

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: RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days
ClinicalTrials.gov ID: NCT00168805
Acronym / sponsor ID: 1160.25
Conditions: Arthroplasty, Replacement, Knee, Thromboembolism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,101 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: May 2006 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 17 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 220 mg	Experimental	Drug: dabigatran etexilate220 mg once daily
dabigatran etexilate 150 mg	Experimental	Drug: dabigatran etexilate150 mg once daily
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, elect ive total knee 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, arteriovenous (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 aspartate aminotransferase (AST) or alanine transaminase (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
enoxaparin40 mg once daily	Drug	enoxaparin
dabigatran etexilate150 mg once daily	Drug	dabigatran etexilate 150 mg
dabigatran etexilate220 mg once daily	Drug	dabigatran etexilate 220 mg

Primary outcome

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Time frame: First administration until 6-10 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

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Time frame: First administration until 6-10 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Time frame: First administration until 6-10 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Time frame: First administration until 6-10 days
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Time frame: First administration until 6-10 days
Number of Participants With Pulmonary Embolism During Treatment Period
Time frame: First administration until 6-10 days
Number of Participants Who Died During Treatment Period
Time frame: First administration until 6-10 days
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Time frame: 3 months
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Time frame: First administration until 6-10 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 17 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	679	608
Dabigatran 150mg	703	625
Enoxaparin	694	616

Primary outcome: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Time frame: First administration until 6-10 days. Number. Unit: Participants

Measure	Dabigatran 220mg n = 503	Dabigatran 150mg n = 526	Enoxaparin n = 512
Value	183	213	193

Dabigatran 220mg vs Enoxaparin: Risk Difference (Percentage): -1.3 (95% CI -7.3 to 4.6), p = 0.6648, Normal approximation
Dabigatran 150mg vs Enoxaparin: Risk Difference (Percentage): 2.8 (95% CI -3.1 to 8.7), p = 0.3553, 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 had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration to end of study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran 220mg	31 of 679 (4.6%)	405 of 679 (59.6%)	Not reported
Dabigatran 150mg	44 of 703 (6.3%)	438 of 703 (62.3%)	Not reported
Enoxaparin	43 of 694 (6.2%)	426 of 694 (61.4%)	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 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.
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

105 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing enoxaparin and dabigatran etexilate in people with Arthroplasty, Replacement, Knee and Thromboembolism, run by Boehringer Ingelheim at 105 sites in 15 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 105 sites in Australia, Spain, Czechia, France, Germany and 10 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 17 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?

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (time frame: First administration until 6-10 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 NCT00168805, 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 19 May 2014.