MedDataX Logo

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

NCT ID: NCT00168818

Last Updated: 2014-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

NCT00657150

Venous Thromboembolism
COMPLETED PHASE3

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

NCT00152971

Arthroplasty, Replacement, Knee Thromboembolism
COMPLETED PHASE3

Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

NCT00846807

Arthroplasty, Replacement Thromboembolism
COMPLETED

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

NCT00168805

Arthroplasty, Replacement, Knee Thromboembolism
COMPLETED PHASE3

Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

NCT01153698

Venous Thromboembolism Arthroplasty, Replacement
TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thromboembolism Arthroplasty, Replacement, Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dabigatran etexilate 75 mg

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

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

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

dabigatran etexilate 110 mg

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

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

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

enoxaparin

40 mg once daily

Group Type ACTIVE_COMPARATOR

enoxaparin

Intervention Type DRUG

40 mg once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dabigatran etexilate

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

Intervention Type DRUG

dabigatran etexilate

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

Intervention Type DRUG

enoxaparin

40 mg once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boehringer Ingelheim

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1160.48.06108 Canberra Hospital

Garren, Australian Capital Territory, Australia

Site Status

1160.48.06106 St George Public Hospital

Kogarah, New South Wales, Australia

Site Status

1160.48.06110 Suite 13 level 4

Lismore, New South Wales, Australia

Site Status

1160.48.06105 Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status

1160.48.06104 Ecru

Box Hill, Victoria, Australia

Site Status

1160.48.06102 Monash Medical Centre

Clayton, Victoria, Australia

Site Status

1160.48.06101 Emeritus Research

Malvern, Victoria, Australia

Site Status

1160.48.06103 Maroondah Hospital

Ringwood East, Victoria, Australia

Site Status

1160.48.06113

Windsor, Victoria, Australia

Site Status

1160.48.06111 Haemophillia & Thrombosis Service

Perth, Western Australia, Australia

Site Status

1160.48.04304 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

1160.48.04302 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1160.48.04303 Boehringer Ingelheim Investigational Site

Wels, , Austria

Site Status

1160.48.04301 Boehringer Ingelheim Investigational Site

Wiener Neustadt, , Austria

Site Status

1160.48.03207 UVC Brugmann

Brussels, , Belgium

Site Status

1160.48.03206 Campus Sint-Lucas

Ghent, , Belgium

Site Status

1160.48.03208 UZ Gent

Ghent, , Belgium

Site Status

1160.48.03202 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

1160.48.03203 AZ Sint Elisabeth

Herentals, , Belgium

Site Status

1160.48.03205 Ziekenhuis Oost-Limburg

Lanaken, , Belgium

Site Status

1160.48.03201 UZ Gasthuisberg

Leuven, , Belgium

Site Status

1160.48.42004 Boehringer Ingelheim Investigational Site

Brno-Bohunice, , Czechia

Site Status

1160.48.42010 Boehringer Ingelheim Investigational Site

Chomutov, , Czechia

Site Status

1160.48.42009 Boehringer Ingelheim Investigational Site

Havlíčkův Brod, , Czechia

Site Status

1160.48.42008 Boehringer Ingelheim Investigational Site

Jihlava, , Czechia

Site Status

1160.48.42002 Boehringer Ingelheim Investigational Site

Kladno, , Czechia

Site Status

1160.48.42006 Boehringer Ingelheim Investigational Site

Kolín, , Czechia

Site Status

1160.48.42003 Boehringer Ingelheim Investigational Site

Ostrava, , Czechia

Site Status

1160.48.42001 Boehringer Ingelheim Investigational Site

Pilsen, , Czechia

Site Status

1160.48.42007 Boehringer Ingelheim Investigational Site

Pradubice, , Czechia

Site Status

1160.48.42005 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1160.48.04571 Boehringer Ingelheim Investigational Site

Hellerup, , Denmark

Site Status

1160.48.04570 Boehringer Ingelheim Investigational Site

Hørsholm, , Denmark

Site Status

1160.48.04573 Boehringer Ingelheim Investigational Site

København NV, , Denmark

Site Status

1160.48.04574 Boehringer Ingelheim Investigational Site

København S, , Denmark

Site Status

1160.48.04575 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1160.48.35803 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Site Status

1160.48.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, , Finland

Site Status

1160.48.35801 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

1160.48.35804 Boehringer Ingelheim Investigational Site

Seinäjoki, , Finland

Site Status

1160.48.35805 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

1160.48.03304 Boehringer Ingelheim Investigational Site

Amiens, , France

Site Status

1160.48.03303 Boehringer Ingelheim Investigational Site

Roubaix, , France

Site Status

1160.48.03302 Boehringer Ingelheim Investigational Site

Soyaux, , France

Site Status

1160.48.03308 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1160.48.04906 Caritaskrankenhaus

Bad Mergentheim, , Germany

Site Status

1160.48.04910 F.-A.-Universität Erlangen-Nürnberg

Erlangen, , Germany

Site Status

1160.48.04904 Orthopädische Universitätsklinik

Frankfurt, , Germany

Site Status

1160.48.04902 Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, , Germany

Site Status

1160.48.04914 St. Bernhard-Hospital

Kamp-Lintfort, , Germany

Site Status

1160.48.04907 Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

1160.48.04912 Orthopädische Klinik Markgröningen gGmbH

Markgröningen, , Germany

Site Status

1160.48.04901 Kreiskrankenhaus

Rheinfelden, , Germany

Site Status

1160.48.04915 Orthopädische Klinik Lindenlohe

Schwandorf in Bayern, , Germany

Site Status

1160.48.04903 Hellmuth-Ulrici-Kliniken

Sommerfeld, , Germany

Site Status

1160.48.04905 Aukammklinik

Wiesbaden, , Germany

Site Status

1160.48.03607 Boehringer Ingelheim Investigational Site

Békéscsaba, , Hungary

Site Status

1160.48.03603 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.48.03606 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.48.03601 Boehringer Ingelheim Investigational Site

Gyula, , Hungary

Site Status

1160.48.03604 Boehringer Ingelheim Investigational Site

Kecskemét, , Hungary

Site Status

1160.48.03602 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

1160.48.03605 Boehringer Ingelheim Investigational Site

Székesfehérvár, , Hungary

Site Status

1160.48.03903 Boehringer Ingelheim Investigational Site

Bergamo, , Italy

Site Status

1160.48.03904 Boehringer Ingelheim Investigational Site

Bologna, , Italy

Site Status

1160.48.03902 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1160.48.03901 Boehringer Ingelheim Investigational Site

Pavia, , Italy

Site Status

1160.48.03102 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1160.48.03101 Boehringer Ingelheim Investigational Site

Heemstede, , Netherlands

Site Status

1160.48.03107 Boehringer Ingelheim Investigational Site

Helmond, , Netherlands

Site Status

1160.48.03103 Boehringer Ingelheim Investigational Site

Hilversum, , Netherlands

Site Status

1160.48.03104 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

Site Status

1160.48.03105 Boehringer Ingelheim Investigational Site

Sittard, , Netherlands

Site Status

1160.48.04703 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

Site Status

1160.48.04701 Boehringer Ingelheim Investigational Site

Bodø, , Norway

Site Status

1160.48.04704 Boehringer Ingelheim Investigational Site

Bærum Postterminal, , Norway

Site Status

1160.48.04707 Boehringer Ingelheim Investigational Site

Bærum Postterminal, , Norway

Site Status

1160.48.04706 Boehringer Ingelheim Investigational Site

Elverum, , Norway

Site Status

1160.48.04702 Boehringer Ingelheim Investigational Site

Skien, , Norway

Site Status

1160.48.04810 Boehringer Ingelheim Investigational Site

Bialystok, , Poland

Site Status

1160.48.04804 Boehringer Ingelheim Investigational Site

Kielce, , Poland

Site Status

1160.48.04806 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1160.48.04807 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1160.48.04812 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1160.48.04820 Boehringer Ingelheim Investigational Site

Lodz, , Poland

Site Status

1160.48.04814 Boehringer Ingelheim Investigational Site

Mielec, , Poland

Site Status

1160.48.04808 Boehringer Ingelheim Investigational Site

Piekary Śląskie, , Poland

Site Status

1160.48.04817 Boehringer Ingelheim Investigational Site

Rzeszów, , Poland

Site Status

1160.48.04801 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.48.04802 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.48.04803 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.48.02701 Boehringer Ingelheim Investigational Site

Bryanston, , South Africa

Site Status

1160.48.02704 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Site Status

1160.48.02703 Boehringer Ingelheim Investigational Site

Randburg, , South Africa

Site Status

1160.48.02702 Boehringer Ingelheim Investigational Site

Sandton, , South Africa

Site Status

1160.48.03405 Boehringer Ingelheim Investigational Site

Alcorcón (Madrid), , Spain

Site Status

1160.48.03403 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.48.03411 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.48.03407 Boehringer Ingelheim Investigational Site

Hospitalet (Barcelona), , Spain

Site Status

1160.48.03409 Boehringer Ingelheim Investigational Site

Jaén, , Spain

Site Status

1160.48.03401 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.48.03402 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.48.03404 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.48.03406 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.48.03408 Boehringer Ingelheim Investigational Site

Móstoles (Madrid), , Spain

Site Status

1160.48.03410 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1160.48.04602 Boehringer Ingelheim Investigational Site

Falköping, , Sweden

Site Status

1160.48.04601 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.48.04607 Boehringer Ingelheim Investigational Site

Halmstad, , Sweden

Site Status

1160.48.04606 Boehringer Ingelheim Investigational Site

Kalmar, , Sweden

Site Status

1160.48.04603 Boehringer Ingelheim Investigational Site

Kungälv, , Sweden

Site Status

1160.48.04608 Boehringer Ingelheim Investigational Site

Lidköping, , Sweden

Site Status

1160.48.04605 Boehringer Ingelheim Investigational Site

Linköping, , Sweden

Site Status

1160.48.04604 Boehringer Ingelheim Investigational Site

Mölndal, , Sweden

Site Status

1160.48.04610 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.48.04609 Boehringer Ingelheim Investigational Site

Varberg, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Austria Belgium Czechia Denmark Finland France Germany Hungary Italy Netherlands Norway Poland South Africa Spain Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26578849 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22995531 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22709460 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17869635 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-001988-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.48

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
NCT01203098 COMPLETED PHASE2
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
NCT01184989 COMPLETED PHASE4
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
NCT01181167 COMPLETED PHASE3
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
NCT00847301 COMPLETED
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
NCT00967447 TERMINATED
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
NCT01181102 COMPLETED PHASE3
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
NCT00074828 COMPLETED PHASE2
Dose Ranging Study in Elective Total Hip Replacement Surgery
NCT00338897 COMPLETED PHASE2/PHASE3
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
NCT00398216 COMPLETED PHASE2
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
NCT01431456 COMPLETED PHASE3
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
NCT00680186 COMPLETED PHASE3
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00371683 COMPLETED PHASE3
Secondary Prevention of Venous Thrombo Embolism (VTE).
NCT00329238 COMPLETED PHASE3
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
NCT01181141 COMPLETED PHASE3
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
NCT00423319 COMPLETED PHASE3
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
NCT00206089 TERMINATED PHASE3
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
NCT00558259 COMPLETED PHASE3
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
NCT00291330 COMPLETED PHASE3
ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
NCT06611319 RECRUITING PHASE3
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
NCT00902928 COMPLETED PHASE2/PHASE3
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
NCT06581965 RECRUITING PHASE4
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
NCT00107900 COMPLETED PHASE2
VTE Prevention Following Total Hip and Knee Arthroplasty
NCT04075240 RECRUITING PHASE3
Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
NCT01344954 COMPLETED PHASE2
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
NCT03251482 COMPLETED PHASE2