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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00168818




Registration number
NCT00168818
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
19/05/2014

Titles & IDs
Public title
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Scientific 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)
Secondary ID [1] 0 0
2004-001988-21
Secondary ID [2] 0 0
1160.48
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 0 0
Arthroplasty, Replacement, Hip 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - enoxaparin

Experimental: dabigatran etexilate 75 mg - daily dose 150 mg once daily, half a dose on the day of surgery

Experimental: dabigatran etexilate 110 mg - daily dose 220 mg once daily, half a dose on the day of surgery

Active comparator: enoxaparin - 40 mg once daily


Treatment: Drugs: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery

Treatment: Drugs: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery

Treatment: Drugs: enoxaparin
40 mg once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Timepoint [1] 0 0
First administration until 31-38 days
Secondary outcome [1] 0 0
Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Timepoint [1] 0 0
First administration until 31-38 days
Secondary outcome [2] 0 0
Proximal Deep Vein Thrombosis During Treatment Period
Timepoint [2] 0 0
First administration until 31-38 days
Secondary outcome [3] 0 0
Total Deep Vein Thrombosis During Treatment Period
Timepoint [3] 0 0
First administration until 31-38 days
Secondary outcome [4] 0 0
Symptomatic Deep Vein Thrombosis During Treatment Period
Timepoint [4] 0 0
First administration until 31-38 days
Secondary outcome [5] 0 0
Pulmonary Embolism During Treatment Period
Timepoint [5] 0 0
First administration until 31-38 days
Secondary outcome [6] 0 0
Death During Treatment Period
Timepoint [6] 0 0
First administration until 31-38 days
Secondary outcome [7] 0 0
Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Timepoint [7] 0 0
end of treatment to day 91±7
Secondary outcome [8] 0 0
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Timepoint [8] 0 0
First administration until 31-38 days
Secondary outcome [9] 0 0
Blood Transfusion
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Volume of Blood Loss
Timepoint [10] 0 0
Day 1
Secondary outcome [11] 0 0
Laboratory Analyses
Timepoint [11] 0 0
First administration to end of study

Eligibility
Key inclusion criteria
Inclusion criteria

Inclusion criteria (selected):

* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
* Written Informed Consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

Exclusion criteria (selected):

* 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
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
3494
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
1160.48.06108 Canberra Hospital - Garren
Recruitment hospital [2] 0 0
1160.48.06106 St George Public Hospital - Kogarah
Recruitment hospital [3] 0 0
1160.48.06110 Suite 13 level 4 - Lismore
Recruitment hospital [4] 0 0
1160.48.06105 Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
1160.48.06104 Ecru - Box Hill
Recruitment hospital [6] 0 0
1160.48.06102 Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
1160.48.06101 Emeritus Research - Malvern
Recruitment hospital [8] 0 0
1160.48.06103 Maroondah Hospital - Ringwood East
Recruitment hospital [9] 0 0
1160.48.06113 - Windsor
Recruitment hospital [10] 0 0
1160.48.06111 Haemophillia & Thrombosis Service - Perth
Recruitment postcode(s) [1] 0 0
- Garren
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Lismore
Recruitment postcode(s) [4] 0 0
- Bedford Park
Recruitment postcode(s) [5] 0 0
- Box Hill
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Ringwood East
Recruitment postcode(s) [9] 0 0
- Windsor
Recruitment postcode(s) [10] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
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Austria
State/province [2] 0 0
Wels
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Austria
State/province [4] 0 0
Wr. Neustadt
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Hasselt
Country [8] 0 0
Belgium
State/province [8] 0 0
Herentals
Country [9] 0 0
Belgium
State/province [9] 0 0
Lanaken
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Brno-Bohunice
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Chomutov
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Havlickuv Brod
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Jihlava
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Kladno
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Kolin
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Ostrava
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Plzen
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Czech Republic
State/province [19] 0 0
Pradubice
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Czech Republic
State/province [20] 0 0
Prague 8
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Denmark
State/province [21] 0 0
Hellerup
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Denmark
State/province [22] 0 0
Hørsholm
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Denmark
State/province [23] 0 0
København NV
Country [24] 0 0
Denmark
State/province [24] 0 0
København S
Country [25] 0 0
Denmark
State/province [25] 0 0
Silkeborg
Country [26] 0 0
Finland
State/province [26] 0 0
Helsinki
Country [27] 0 0
Finland
State/province [27] 0 0
Jyväskylä
Country [28] 0 0
Finland
State/province [28] 0 0
Oulu
Country [29] 0 0
Finland
State/province [29] 0 0
Seinäjoki
Country [30] 0 0
Finland
State/province [30] 0 0
Tampere
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France
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Amiens cedex 1
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France
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Roubaix cedex
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France
State/province [33] 0 0
Soyaux
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France
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Strasbourg
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Germany
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Bad Mergentheim
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Germany
State/province [36] 0 0
Erlangen
Country [37] 0 0
Germany
State/province [37] 0 0
Frankfurt
Country [38] 0 0
Germany
State/province [38] 0 0
Garmisch-Partenkirchen
Country [39] 0 0
Germany
State/province [39] 0 0
Kamp-Lintfort
Country [40] 0 0
Germany
State/province [40] 0 0
Mainz
Country [41] 0 0
Germany
State/province [41] 0 0
Markgröningen
Country [42] 0 0
Germany
State/province [42] 0 0
Rheinfelden
Country [43] 0 0
Germany
State/province [43] 0 0
Schwandorf
Country [44] 0 0
Germany
State/province [44] 0 0
Sommerfeld
Country [45] 0 0
Germany
State/province [45] 0 0
Wiesbaden
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
State/province [47] 0 0
Békéscsaba
Country [48] 0 0
Hungary
State/province [48] 0 0
Gyula
Country [49] 0 0
Hungary
State/province [49] 0 0
Kecskemét
Country [50] 0 0
Hungary
State/province [50] 0 0
Szeged
Country [51] 0 0
Hungary
State/province [51] 0 0
Székesfehérvár
Country [52] 0 0
Italy
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Bergamo
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Italy
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Bologna
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Italy
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Milano
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Italy
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Pavia
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Netherlands
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Amsterdam
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Netherlands
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Heemstede
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Netherlands
State/province [58] 0 0
Helmond
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Netherlands
State/province [59] 0 0
Hilversum
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nijmegen
Country [61] 0 0
Netherlands
State/province [61] 0 0
Sittard
Country [62] 0 0
Norway
State/province [62] 0 0
Bodø
Country [63] 0 0
Norway
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Bærum Postterminal
Country [64] 0 0
Norway
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Elverum
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Norway
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Skien
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Norway
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Ålesund
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Poland
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Bialystok
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Mielec
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Poland
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Piekary Slaskie
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Poland
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Rzeszow
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Poland
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Warsaw
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South Africa
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Bryanston
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South Africa
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Johannesburg
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South Africa
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Randburg
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South Africa
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Sandton
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Spain
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Alcorcón (Madrid)
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
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Spain
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Hospitalet (Barcelona)
Country [82] 0 0
Spain
State/province [82] 0 0
Jaén
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Móstoles (Madrid)
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Sweden
State/province [86] 0 0
Falköping
Country [87] 0 0
Sweden
State/province [87] 0 0
Göteborg
Country [88] 0 0
Sweden
State/province [88] 0 0
Halmstad
Country [89] 0 0
Sweden
State/province [89] 0 0
Kalmar
Country [90] 0 0
Sweden
State/province [90] 0 0
Kungälv
Country [91] 0 0
Sweden
State/province [91] 0 0
Lidköping
Country [92] 0 0
Sweden
State/province [92] 0 0
Linköping
Country [93] 0 0
Sweden
State/province [93] 0 0
Mölndal
Country [94] 0 0
Sweden
State/province [94] 0 0
Stockholm
Country [95] 0 0
Sweden
State/province [95] 0 0
Varberg

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00168818
Trial related presentations / 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.
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.
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.
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. Erratum In: Lancet. 2007 Dec 15;370(9604):2004.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00168818