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 | Completed Phase 3 Results

• 2 other identifiers: 1160.252004-001317-34
• Study Type: interventional
• Target: 2,101
• Locations: 14 countries
• Sites: 93

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  First administration until 6-10 days

• Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

  First administration until 6-10 days

• Number of Participants With Total Deep Vein Thrombosis During Treatment Period

  First administration until 6-10 days

• Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

  First administration until 6-10 days

• Number of Participants With Pulmonary Embolism During Treatment Period

  First administration until 6-10 days

Study Arms (3)

dabigatran etexilate 220 mg

EXPERIMENTAL

220 mg once daily

Drug: dabigatran etexilate

dabigatran etexilate 150 mg

EXPERIMENTAL

150 mg once daily

Drug: dabigatran etexilate

enoxaparin

ACTIVE COMPARATOR

40 mg once daily

Drug: enoxaparin

Interventions

enoxaparin DRUG

40 mg once daily

enoxaparin

dabigatran etexilate DRUG

150 mg once daily

dabigatran etexilate 150 mg

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, elect ive total knee 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, 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (105)

1160.25.06108 Boehringer Ingelheim Investigational Site

Garren, Australian Capital Territory, Australia

Location

1160.25.06106 Boehringer Ingelheim Investigational Site

Kogarah, New South Wales, Australia

Location

1160.25.06110 Boehringer Ingelheim Investigational Site

Lismore, New South Wales, Australia

Location

1160.25.06105 Boehringer Ingelheim Investigational Site

Bedford Park, South Australia, Australia

Location

1160.25.06107 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Location

1160.25.06109 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Location

1160.25.06104 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Location

1160.25.06102 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1160.25.06101 Boehringer Ingelheim Investigational Site

Malvern, Victoria, Australia

Location

1160.25.06103 Boehringer Ingelheim Investigational Site

Ringwood East, Victoria, Australia

Location

1160.25.06113 Boehringer Ingelheim Investigational Site

Windsor, Victoria, Australia

Location

1160.25.06111 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Location

1160.25.04304 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1160.25.04302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.25.04303 Boehringer Ingelheim Investigational Site

Wels, Austria

Location

1160.25.04301 Boehringer Ingelheim Investigational Site

Wiener Neustadt, Austria

Location

1160.25.03207 UVC Brugmann

Brussels, Belgium

Location

1160.25.03209 ZOL St. Jan

Genk, Belgium

Location

1160.25.03206 Campus Sint-Lucas

Ghent, Belgium

Location

1160.25.03208 UZ Gent

Ghent, Belgium

Location

1160.25.03202 Virga Jesseziekenhuis

Hasselt, Belgium

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1160.25.03203 AZ Sint Elisabeth

Herentals, Belgium

Location

1160.25.03205 Ziekenhuis Oost-Limburg

Lanaken, Belgium

Location

1160.25.03201 UZ Gasthuisberg

Leuven, Belgium

Location

1160.25.42004 Boehringer Ingelheim Investigational Site

Brno-Bohunice, Czechia

Location

1160.25.42010 Boehringer Ingelheim Investigational Site

Chomutov, Czechia

Location

1160.25.42009 Boehringer Ingelheim Investigational Site

Havlíčkův Brod, Czechia

Location

1160.25.42002 Boehringer Ingelheim Investigational Site

Kladno, Czechia

Location

1160.25.42006 Boehringer Ingelheim Investigational Site

Kolín, Czechia

Location

1160.25.42003 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

1160.25.42001 Boehringer Ingelheim Investigational Site

Pilsen, Czechia

Location

1160.25.42007 Boehringer Ingelheim Investigational Site

Pradubice, Czechia

Location

1160.25.42005 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.25.04571 Boehringer Ingelheim Investigational Site

Hellerup, Denmark

Location

1160.25.04570 Boehringer Ingelheim Investigational Site

Hørsholm, Denmark

Location

1160.25.04573 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1160.25.04574 Boehringer Ingelheim Investigational Site

København S, Denmark

Location

1160.25.04575 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

Location

1160.25.35803 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1160.25.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

Location

1160.25.35801 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1160.25.35804 Boehringer Ingelheim Investigational Site

Seinäjoki, Finland

Location

1160.25.03304 Boehringer Ingelheim Investigational Site

Amiens, France

Location

1160.25.03307 Boehringer Ingelheim Investigational Site

Annecy, France

Location

1160.25.03305 Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1160.25.03301 Boehringer Ingelheim Investigational Site

Paris, France

Location

1160.25.03306 Boehringer Ingelheim Investigational Site

Poitiers, France

Location

1160.25.03303 Boehringer Ingelheim Investigational Site

Roubaix, France

Location

1160.25.03309 Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.25.03302 Boehringer Ingelheim Investigational Site

Soyaux, France

Location

1160.25.03308 Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1160.25.04906 Caritaskrankenhaus

Bad Mergentheim, Germany

Location

1160.25.04910 F.-A.-Universität Erlangen-Nürnberg

Erlangen, Germany

Location

1160.25.04904 Orthopädische Universitätsklinik

Frankfurt, Germany

Location

1160.25.04902 Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany

Location

1160.25.04911 Martin-Luther-Universität Halle-Wittenberg

Halle, Germany

Location

1160.25.04912 Orthopädische Klinik Markgröningen gGmbH

Markgröningen, Germany

Location

1160.25.04901 Kreiskrankenhaus

Rheinfelden, Germany

Location

1160.25.04903 Hellmuth-Ulrici-Kliniken

Sommerfeld, Germany

Location

1160.25.04905 Aukammklinik

Wiesbaden, Germany

Location

1160.25.03607 Boehringer Ingelheim Investigational Site

Békéscsaba, Hungary

Location

1160.25.03603 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.25.03601 Boehringer Ingelheim Investigational Site

Gyula, Hungary

Location

1160.25.03604 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

1160.25.03602 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

1160.25.03605 Boehringer Ingelheim Investigational Site

Székesfehérvár, Hungary

Location

1160.25.03906 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1160.25.03905 Boehringer Ingelheim Investigational Site

Parma, Italy

Location

1160.25.03901 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

1160.25.03903 Boehringer Ingelheim Investigational Site

Piacenza, Italy

Location

1160.25.03904 Boehringer Ingelheim Investigational Site

Reggio Emilia, Italy

Location

1160.25.03902 Boehringer Ingelheim Investigational Site

Treviso, Italy

Location

1160.25.03102 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.25.03103 Boehringer Ingelheim Investigational Site

Hilversum, Netherlands

Location

1160.25.03101 Boehringer Ingelheim Investigational Site

Hoofddorp, Netherlands

Location

1160.25.03104 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

1160.25.03105 Boehringer Ingelheim Investigational Site

Sittard, Netherlands

Location

1160.25.03106 Boehringer Ingelheim Investigational Site

Zwolle, Netherlands

Location

1160.25.04804 Boehringer Ingelheim Investigational Site

Kielce, Poland

Location

1160.25.04806 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.25.04807 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.25.04803 Boehringer Ingelheim Investigational Site

Warsaw, Poland

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1160.25.02701 Boehringer Ingelheim Investigational Site

Bryanston, South Africa

Location

1160.25.02703 Boehringer Ingelheim Investigational Site

Randburg, South Africa

Location

1160.25.02702 Boehringer Ingelheim Investigational Site

Sandton, South Africa

Location

1160.25.03405 Boehringer Ingelheim Investigational Site

Alcorcón (Madrid), Spain

Location

1160.25.03403 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.25.03411 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.25.03407 Boehringer Ingelheim Investigational Site

Hospitalet (Barcelona), Spain

Location

1160.25.03409 Boehringer Ingelheim Investigational Site

Jaén, Spain

Location

1160.25.03401 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.25.03402 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.25.03404 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.25.03406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.25.03408 Boehringer Ingelheim Investigational Site

Móstoles (Madrid), Spain

Location

1160.25.03410 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.25.04602 Boehringer Ingelheim Investigational Site

Falköping, Sweden

Location

1160.25.04601 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.25.04607 Boehringer Ingelheim Investigational Site

Halmstad, Sweden

Location

1160.25.04603 Boehringer Ingelheim Investigational Site

Kungälv, Sweden

Location

1160.25.04608 Boehringer Ingelheim Investigational Site

Lidköping, Sweden

Location

1160.25.04605 Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

1160.25.04604 Boehringer Ingelheim Investigational Site

Mölndal, Sweden

Location

1160.25.04610 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.25.04609 Boehringer Ingelheim Investigational Site

Varberg, Sweden

Location

Related Publications (2)

• 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

MeSH Terms

Conditions

Thromboembolism

Interventions

Enoxaparin; Dabigatran

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

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: May 1, 2006
• Last Updated: May 19, 2014
• Results First Posted: December 17, 2010

Record last verified: 2014-02

Locations

FI (4); FR (9); CZ (9); HU (6); NL (6); ZA (3); AU (4); DK (5); ES (11); BE (8); PL (4); SE (9); DE (9); IT (6)