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

NCT00168818 | Completed Phase 3 Results

• 2 other identifiers: 1160.482004-001988-21
• Study Type: interventional
• Target: 3,494
• Locations: 15 countries
• Sites: 112

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.

Conditions

Thromboembolism; Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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.

  First administration until 31-38 days

Secondary Outcomes (11)

• Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

  First administration until 31-38 days

• Proximal Deep Vein Thrombosis During Treatment Period

  First administration until 31-38 days

• Total Deep Vein Thrombosis During Treatment Period

  First administration until 31-38 days

• Symptomatic Deep Vein Thrombosis During Treatment Period

  First administration until 31-38 days

• Pulmonary Embolism During Treatment Period

  First administration until 31-38 days

Study Arms (3)

dabigatran etexilate 75 mg

EXPERIMENTAL

daily dose 150 mg once daily, half a dose on the day of surgery

Drug: dabigatran etexilate

dabigatran etexilate 110 mg

EXPERIMENTAL

daily dose 220 mg once daily, half a dose on the day of surgery

Drug: dabigatran etexilate

enoxaparin

ACTIVE COMPARATOR

40 mg once daily

Drug: enoxaparin

Interventions

dabigatran etexilate DRUG

daily dose 150 mg once daily, half a dose on the day of surgery

dabigatran etexilate 75 mg

enoxaparin DRUG

40 mg once daily

enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
• Written Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (116)

1160.48.06108 Canberra Hospital

Garren, Australian Capital Territory, Australia

Location

1160.48.06106 St George Public Hospital

Kogarah, New South Wales, Australia

Location

1160.48.06110 Suite 13 level 4

Lismore, New South Wales, Australia

Location

1160.48.06105 Flinders Medical Centre

Bedford Park, South Australia, Australia

Location

1160.48.06104 Ecru

Box Hill, Victoria, Australia

Location

1160.48.06102 Monash Medical Centre

Clayton, Victoria, Australia

Location

1160.48.06101 Emeritus Research

Malvern, Victoria, Australia

Location

1160.48.06103 Maroondah Hospital

Ringwood East, Victoria, Australia

Location

1160.48.06113

Windsor, Victoria, Australia

Location

1160.48.06111 Haemophillia & Thrombosis Service

Perth, Western Australia, Australia

Location

1160.48.04304 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1160.48.04302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.48.04303 Boehringer Ingelheim Investigational Site

Wels, Austria

Location

1160.48.04301 Boehringer Ingelheim Investigational Site

Wiener Neustadt, Austria

Location

1160.48.03207 UVC Brugmann

Brussels, Belgium

Location

1160.48.03206 Campus Sint-Lucas

Ghent, Belgium

Location

1160.48.03208 UZ Gent

Ghent, Belgium

Location

1160.48.03202 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1160.48.03203 AZ Sint Elisabeth

Herentals, Belgium

Location

1160.48.03205 Ziekenhuis Oost-Limburg

Lanaken, Belgium

Location

1160.48.03201 UZ Gasthuisberg

Leuven, Belgium

Location

1160.48.42004 Boehringer Ingelheim Investigational Site

Brno-Bohunice, Czechia

Location

1160.48.42010 Boehringer Ingelheim Investigational Site

Chomutov, Czechia

Location

1160.48.42009 Boehringer Ingelheim Investigational Site

Havlíčkův Brod, Czechia

Location

1160.48.42008 Boehringer Ingelheim Investigational Site

Jihlava, Czechia

Location

1160.48.42002 Boehringer Ingelheim Investigational Site

Kladno, Czechia

Location

1160.48.42006 Boehringer Ingelheim Investigational Site

Kolín, Czechia

Location

1160.48.42003 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

1160.48.42001 Boehringer Ingelheim Investigational Site

Pilsen, Czechia

Location

1160.48.42007 Boehringer Ingelheim Investigational Site

Pradubice, Czechia

Location

1160.48.42005 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.48.04571 Boehringer Ingelheim Investigational Site

Hellerup, Denmark

Location

1160.48.04570 Boehringer Ingelheim Investigational Site

Hørsholm, Denmark

Location

1160.48.04573 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1160.48.04574 Boehringer Ingelheim Investigational Site

København S, Denmark

Location

1160.48.04575 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

Location

1160.48.35803 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1160.48.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

Location

1160.48.35801 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1160.48.35804 Boehringer Ingelheim Investigational Site

Seinäjoki, Finland

Location

1160.48.35805 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

1160.48.03304 Boehringer Ingelheim Investigational Site

Amiens, France

Location

1160.48.03303 Boehringer Ingelheim Investigational Site

Roubaix, France

Location

1160.48.03302 Boehringer Ingelheim Investigational Site

Soyaux, France

Location

1160.48.03308 Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1160.48.04906 Caritaskrankenhaus

Bad Mergentheim, Germany

Location

1160.48.04910 F.-A.-Universität Erlangen-Nürnberg

Erlangen, Germany

Location

1160.48.04904 Orthopädische Universitätsklinik

Frankfurt, Germany

Location

1160.48.04902 Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany

Location

1160.48.04914 St. Bernhard-Hospital

Kamp-Lintfort, Germany

Location

1160.48.04907 Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

1160.48.04912 Orthopädische Klinik Markgröningen gGmbH

Markgröningen, Germany

Location

1160.48.04901 Kreiskrankenhaus

Rheinfelden, Germany

Location

1160.48.04915 Orthopädische Klinik Lindenlohe

Schwandorf in Bayern, Germany

Location

1160.48.04903 Hellmuth-Ulrici-Kliniken

Sommerfeld, Germany

Location

1160.48.04905 Aukammklinik

Wiesbaden, Germany

Location

1160.48.03607 Boehringer Ingelheim Investigational Site

Békéscsaba, Hungary

Location

1160.48.03603 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.48.03606 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.48.03601 Boehringer Ingelheim Investigational Site

Gyula, Hungary

Location

1160.48.03604 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

1160.48.03602 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

1160.48.03605 Boehringer Ingelheim Investigational Site

Székesfehérvár, Hungary

Location

1160.48.03903 Boehringer Ingelheim Investigational Site

Bergamo, Italy

Location

1160.48.03904 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1160.48.03902 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.48.03901 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

1160.48.03102 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.48.03101 Boehringer Ingelheim Investigational Site

Heemstede, Netherlands

Location

1160.48.03107 Boehringer Ingelheim Investigational Site

Helmond, Netherlands

Location

1160.48.03103 Boehringer Ingelheim Investigational Site

Hilversum, Netherlands

Location

1160.48.03104 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

1160.48.03105 Boehringer Ingelheim Investigational Site

Sittard, Netherlands

Location

1160.48.04703 Boehringer Ingelheim Investigational Site

Ålesund, Norway

Location

1160.48.04701 Boehringer Ingelheim Investigational Site

Bodø, Norway

Location

1160.48.04704 Boehringer Ingelheim Investigational Site

Bærum Postterminal, Norway

Location

1160.48.04707 Boehringer Ingelheim Investigational Site

Bærum Postterminal, Norway

Location

1160.48.04706 Boehringer Ingelheim Investigational Site

Elverum, Norway

Location

1160.48.04702 Boehringer Ingelheim Investigational Site

Skien, Norway

Location

1160.48.04810 Boehringer Ingelheim Investigational Site

Bialystok, Poland

Location

1160.48.04804 Boehringer Ingelheim Investigational Site

Kielce, Poland

Location

1160.48.04806 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.48.04807 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.48.04812 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.48.04820 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1160.48.04814 Boehringer Ingelheim Investigational Site

Mielec, Poland

Location

1160.48.04808 Boehringer Ingelheim Investigational Site

Piekary Śląskie, Poland

Location

1160.48.04817 Boehringer Ingelheim Investigational Site

Rzeszów, Poland

Location

1160.48.04801 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.48.04802 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.48.04803 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.48.02701 Boehringer Ingelheim Investigational Site

Bryanston, South Africa

Location

1160.48.02704 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.48.02703 Boehringer Ingelheim Investigational Site

Randburg, South Africa

Location

1160.48.02702 Boehringer Ingelheim Investigational Site

Sandton, South Africa

Location

1160.48.03405 Boehringer Ingelheim Investigational Site

Alcorcón (Madrid), Spain

Location

1160.48.03403 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.48.03411 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.48.03407 Boehringer Ingelheim Investigational Site

Hospitalet (Barcelona), Spain

Location

1160.48.03409 Boehringer Ingelheim Investigational Site

Jaén, Spain

Location

1160.48.03401 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.48.03402 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.48.03404 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.48.03406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.48.03408 Boehringer Ingelheim Investigational Site

Móstoles (Madrid), Spain

Location

1160.48.03410 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.48.04602 Boehringer Ingelheim Investigational Site

Falköping, Sweden

Location

1160.48.04601 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.48.04607 Boehringer Ingelheim Investigational Site

Halmstad, Sweden

Location

1160.48.04606 Boehringer Ingelheim Investigational Site

Kalmar, Sweden

Location

1160.48.04603 Boehringer Ingelheim Investigational Site

Kungälv, Sweden

Location

1160.48.04608 Boehringer Ingelheim Investigational Site

Lidköping, Sweden

Location

1160.48.04605 Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

1160.48.04604 Boehringer Ingelheim Investigational Site

Mölndal, Sweden

Location

1160.48.04610 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.48.04609 Boehringer Ingelheim Investigational Site

Varberg, Sweden

Location

Related Publications (4)

• 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.

  PMID: 26578849 DERIVED

• 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.

  PMID: 22995531 DERIVED

• 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.

  PMID: 22709460 DERIVED

• 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.

  PMID: 17869635 DERIVED

MeSH Terms

Conditions

Thromboembolism

Interventions

Dabigatran; Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2004
• Primary Completion: July 1, 2006
• Last Updated: May 19, 2014
• Results First Posted: December 20, 2010

Record last verified: 2014-02

Locations

HU (7); FI (5); AU (10); FR (4); DE (11); PL (12); ES (11); SE (10); DK (5); BE (7); ZA (4); NO (6); IT (4); NL (6); CZ (10)