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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

NCT ID: NCT00168805

Last Updated: 2014-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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dabigatran etexilate 220 mg

220 mg once daily

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

220 mg once daily

dabigatran etexilate 150 mg

150 mg once daily

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

150 mg once daily

enoxaparin

40 mg once daily

Group Type ACTIVE_COMPARATOR

enoxaparin

Intervention Type DRUG

40 mg once daily

Interventions

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enoxaparin

40 mg once daily

Intervention Type DRUG

dabigatran etexilate

150 mg once daily

Intervention Type DRUG

dabigatran etexilate

220 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee 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, 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.25.06108 Boehringer Ingelheim Investigational Site

Garren, Australian Capital Territory, Australia

Site Status

1160.25.06106 Boehringer Ingelheim Investigational Site

Kogarah, New South Wales, Australia

Site Status

1160.25.06110 Boehringer Ingelheim Investigational Site

Lismore, New South Wales, Australia

Site Status

1160.25.06105 Boehringer Ingelheim Investigational Site

Bedford Park, South Australia, Australia

Site Status

1160.25.06107 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Site Status

1160.25.06109 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Site Status

1160.25.06104 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Site Status

1160.25.06102 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Site Status

1160.25.06101 Boehringer Ingelheim Investigational Site

Malvern, Victoria, Australia

Site Status

1160.25.06103 Boehringer Ingelheim Investigational Site

Ringwood East, Victoria, Australia

Site Status

1160.25.06113 Boehringer Ingelheim Investigational Site

Windsor, Victoria, Australia

Site Status

1160.25.06111 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Site Status

1160.25.04304 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

1160.25.04302 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1160.25.04303 Boehringer Ingelheim Investigational Site

Wels, , Austria

Site Status

1160.25.04301 Boehringer Ingelheim Investigational Site

Wiener Neustadt, , Austria

Site Status

1160.25.03207 UVC Brugmann

Brussels, , Belgium

Site Status

1160.25.03209 ZOL St. Jan

Genk, , Belgium

Site Status

1160.25.03206 Campus Sint-Lucas

Ghent, , Belgium

Site Status

1160.25.03208 UZ Gent

Ghent, , Belgium

Site Status

1160.25.03202 Virga Jesseziekenhuis

Hasselt, , Belgium

Site Status

1160.25.03203 AZ Sint Elisabeth

Herentals, , Belgium

Site Status

1160.25.03205 Ziekenhuis Oost-Limburg

Lanaken, , Belgium

Site Status

1160.25.03201 UZ Gasthuisberg

Leuven, , Belgium

Site Status

1160.25.42004 Boehringer Ingelheim Investigational Site

Brno-Bohunice, , Czechia

Site Status

1160.25.42010 Boehringer Ingelheim Investigational Site

Chomutov, , Czechia

Site Status

1160.25.42009 Boehringer Ingelheim Investigational Site

Havlíčkův Brod, , Czechia

Site Status

1160.25.42002 Boehringer Ingelheim Investigational Site

Kladno, , Czechia

Site Status

1160.25.42006 Boehringer Ingelheim Investigational Site

Kolín, , Czechia

Site Status

1160.25.42003 Boehringer Ingelheim Investigational Site

Ostrava, , Czechia

Site Status

1160.25.42001 Boehringer Ingelheim Investigational Site

Pilsen, , Czechia

Site Status

1160.25.42007 Boehringer Ingelheim Investigational Site

Pradubice, , Czechia

Site Status

1160.25.42005 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1160.25.04571 Boehringer Ingelheim Investigational Site

Hellerup, , Denmark

Site Status

1160.25.04570 Boehringer Ingelheim Investigational Site

Hørsholm, , Denmark

Site Status

1160.25.04573 Boehringer Ingelheim Investigational Site

København NV, , Denmark

Site Status

1160.25.04574 Boehringer Ingelheim Investigational Site

København S, , Denmark

Site Status

1160.25.04575 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1160.25.35803 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Site Status

1160.25.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, , Finland

Site Status

1160.25.35801 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

1160.25.35804 Boehringer Ingelheim Investigational Site

Seinäjoki, , Finland

Site Status

1160.25.03304 Boehringer Ingelheim Investigational Site

Amiens, , France

Site Status

1160.25.03307 Boehringer Ingelheim Investigational Site

Annecy, , France

Site Status

1160.25.03305 Boehringer Ingelheim Investigational Site

La Rochelle, , France

Site Status

1160.25.03301 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1160.25.03306 Boehringer Ingelheim Investigational Site

Poitiers, , France

Site Status

1160.25.03303 Boehringer Ingelheim Investigational Site

Roubaix, , France

Site Status

1160.25.03309 Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

Site Status

1160.25.03302 Boehringer Ingelheim Investigational Site

Soyaux, , France

Site Status

1160.25.03308 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1160.25.04906 Caritaskrankenhaus

Bad Mergentheim, , Germany

Site Status

1160.25.04910 F.-A.-Universität Erlangen-Nürnberg

Erlangen, , Germany

Site Status

1160.25.04904 Orthopädische Universitätsklinik

Frankfurt, , Germany

Site Status

1160.25.04902 Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, , Germany

Site Status

1160.25.04911 Martin-Luther-Universität Halle-Wittenberg

Halle, , Germany

Site Status

1160.25.04912 Orthopädische Klinik Markgröningen gGmbH

Markgröningen, , Germany

Site Status

1160.25.04901 Kreiskrankenhaus

Rheinfelden, , Germany

Site Status

1160.25.04903 Hellmuth-Ulrici-Kliniken

Sommerfeld, , Germany

Site Status

1160.25.04905 Aukammklinik

Wiesbaden, , Germany

Site Status

1160.25.03607 Boehringer Ingelheim Investigational Site

Békéscsaba, , Hungary

Site Status

1160.25.03603 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1160.25.03601 Boehringer Ingelheim Investigational Site

Gyula, , Hungary

Site Status

1160.25.03604 Boehringer Ingelheim Investigational Site

Kecskemét, , Hungary

Site Status

1160.25.03602 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

1160.25.03605 Boehringer Ingelheim Investigational Site

Székesfehérvár, , Hungary

Site Status

1160.25.03906 Boehringer Ingelheim Investigational Site

Bologna, , Italy

Site Status

1160.25.03905 Boehringer Ingelheim Investigational Site

Parma, , Italy

Site Status

1160.25.03901 Boehringer Ingelheim Investigational Site

Pavia, , Italy

Site Status

1160.25.03903 Boehringer Ingelheim Investigational Site

Piacenza, , Italy

Site Status

1160.25.03904 Boehringer Ingelheim Investigational Site

Reggio Emilia, , Italy

Site Status

1160.25.03902 Boehringer Ingelheim Investigational Site

Treviso, , Italy

Site Status

1160.25.03102 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1160.25.03103 Boehringer Ingelheim Investigational Site

Hilversum, , Netherlands

Site Status

1160.25.03101 Boehringer Ingelheim Investigational Site

Hoofddorp, , Netherlands

Site Status

1160.25.03104 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

Site Status

1160.25.03105 Boehringer Ingelheim Investigational Site

Sittard, , Netherlands

Site Status

1160.25.03106 Boehringer Ingelheim Investigational Site

Zwolle, , Netherlands

Site Status

1160.25.04804 Boehringer Ingelheim Investigational Site

Kielce, , Poland

Site Status

1160.25.04806 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1160.25.04807 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1160.25.04803 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1160.25.02701 Boehringer Ingelheim Investigational Site

Bryanston, , South Africa

Site Status

1160.25.02703 Boehringer Ingelheim Investigational Site

Randburg, , South Africa

Site Status

1160.25.02702 Boehringer Ingelheim Investigational Site

Sandton, , South Africa

Site Status

1160.25.03405 Boehringer Ingelheim Investigational Site

Alcorcón (Madrid), , Spain

Site Status

1160.25.03403 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.25.03411 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1160.25.03407 Boehringer Ingelheim Investigational Site

Hospitalet (Barcelona), , Spain

Site Status

1160.25.03409 Boehringer Ingelheim Investigational Site

Jaén, , Spain

Site Status

1160.25.03401 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.25.03402 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.25.03404 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.25.03406 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1160.25.03408 Boehringer Ingelheim Investigational Site

Móstoles (Madrid), , Spain

Site Status

1160.25.03410 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1160.25.04602 Boehringer Ingelheim Investigational Site

Falköping, , Sweden

Site Status

1160.25.04601 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.25.04607 Boehringer Ingelheim Investigational Site

Halmstad, , Sweden

Site Status

1160.25.04603 Boehringer Ingelheim Investigational Site

Kungälv, , Sweden

Site Status

1160.25.04608 Boehringer Ingelheim Investigational Site

Lidköping, , Sweden

Site Status

1160.25.04605 Boehringer Ingelheim Investigational Site

Linköping, , Sweden

Site Status

1160.25.04604 Boehringer Ingelheim Investigational Site

Mölndal, , Sweden

Site Status

1160.25.04610 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.25.04609 Boehringer Ingelheim Investigational Site

Varberg, , Sweden

Site Status

Countries

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

References

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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)

Other Identifiers

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2004-001317-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.25

Identifier Type: -

Identifier Source: org_study_id

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