Clinical trial NCT00168805: 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
Official title: RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthroplasty, Replacement, Knee
Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 2101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)


Eligibility criteria: Inclusion criteria

Inclusion criteria (selected):

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

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, 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

Primary outcomes:
measure: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
timeFrame: First administration until 6-10 days
Secondary outcomes:
measure: Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
timeFrame: First administration until 6-10 days
measure: Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
timeFrame: First administration until 6-10 days
measure: Number of Participants With Total Deep Vein Thrombosis During Treatment Period
timeFrame: First administration until 6-10 days
measure: Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
timeFrame: First administration until 6-10 days
measure: Number of Participants With Pulmonary Embolism During Treatment Period
timeFrame: First administration until 6-10 days
measure: Number of Participants Who Died During Treatment Period
timeFrame: First administration until 6-10 days
measure: Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
timeFrame: 3 months
measure: Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
timeFrame: First administration until 6-10 days
measure: Blood Transfusion
timeFrame: Day 1
measure: Volume of Blood Loss
timeFrame: Day 1
measure: Laboratory Analyses
timeFrame: First administration to end of study
Other outcomes:
Locations:
city: Garren
country: Australia
facility: 1160.25.06108 Boehringer Ingelheim Investigational Site
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: 1160.25.06106 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Lismore
country: Australia
facility: 1160.25.06110 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Bedford Park
country: Australia
facility: 1160.25.06105 Boehringer Ingelheim Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: 1160.25.06107 Boehringer Ingelheim Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: 1160.25.06109 Boehringer Ingelheim Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: 1160.25.06104 Boehringer Ingelheim Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: 1160.25.06102 Boehringer Ingelheim Investigational Site
state: Victoria
city: Malvern
country: Australia
facility: 1160.25.06101 Boehringer Ingelheim Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: 1160.25.06103 Boehringer Ingelheim Investigational Site
state: Victoria
city: Windsor
country: Australia
facility: 1160.25.06113 Boehringer Ingelheim Investigational Site
state: Victoria
city: Perth
country: Australia
facility: 1160.25.06111 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Linz
country: Austria
facility: 1160.25.04304 Boehringer Ingelheim Investigational Site
city: Wels
country: Austria
facility: 1160.25.04303 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.25.04302 Boehringer Ingelheim Investigational Site
city: Wr. Neustadt
country: Austria
facility: 1160.25.04301 Boehringer Ingelheim Investigational Site
city: Brussels
country: Belgium
facility: 1160.25.03207 UVC Brugmann
city: Genk
country: Belgium
facility: 1160.25.03209 ZOL St. Jan
city: Gent
country: Belgium
facility: 1160.25.03206 Campus Sint-Lucas
city: Gent
country: Belgium
facility: 1160.25.03208 UZ Gent
city: Hasselt
country: Belgium
facility: 1160.25.03202 Virga Jesseziekenhuis
city: Herentals
country: Belgium
facility: 1160.25.03203 AZ Sint Elisabeth
city: Lanaken
country: Belgium
facility: 1160.25.03205 Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: 1160.25.03201 UZ Gasthuisberg
city: Brno-Bohunice
country: Czech Republic
facility: 1160.25.42004 Boehringer Ingelheim Investigational Site
city: Chomutov
country: Czech Republic
facility: 1160.25.42010 Boehringer Ingelheim Investigational Site
city: Havlickuv Brod
country: Czech Republic
facility: 1160.25.42009 Boehringer Ingelheim Investigational Site
city: Kladno
country: Czech Republic
facility: 1160.25.42002 Boehringer Ingelheim Investigational Site
city: Kolin
country: Czech Republic
facility: 1160.25.42006 Boehringer Ingelheim Investigational Site
city: Ostrava
country: Czech Republic
facility: 1160.25.42003 Boehringer Ingelheim Investigational Site
city: Plzen
country: Czech Republic
facility: 1160.25.42001 Boehringer Ingelheim Investigational Site
city: Pradubice
country: Czech Republic
facility: 1160.25.42007 Boehringer Ingelheim Investigational Site
city: Prague 8
country: Czech Republic
facility: 1160.25.42005 Boehringer Ingelheim Investigational Site
city: Hellerup
country: Denmark
facility: 1160.25.04571 Boehringer Ingelheim Investigational Site
city: Hørsholm
country: Denmark
facility: 1160.25.04570 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1160.25.04573 Boehringer Ingelheim Investigational Site
city: København S
country: Denmark
facility: 1160.25.04574 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1160.25.04575 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1160.25.35803 Boehringer Ingelheim Investigational Site
city: Jyväskylä
country: Finland
facility: 1160.25.35802 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1160.25.35801 Boehringer Ingelheim Investigational Site
city: Seinäjoki
country: Finland
facility: 1160.25.35804 Boehringer Ingelheim Investigational Site
city: Amiens cedex 1
country: France
facility: 1160.25.03304 Boehringer Ingelheim Investigational Site
city: Annecy
country: France
facility: 1160.25.03307 Boehringer Ingelheim Investigational Site
city: La Rochelle
country: France
facility: 1160.25.03305 Boehringer Ingelheim Investigational Site
city: Paris cedex 14
country: France
facility: 1160.25.03301 Boehringer Ingelheim Investigational Site
city: Poitiers cedex
country: France
facility: 1160.25.03306 Boehringer Ingelheim Investigational Site
city: Roubaix cedex
country: France
facility: 1160.25.03303 Boehringer Ingelheim Investigational Site
city: Soyaux
country: France
facility: 1160.25.03302 Boehringer Ingelheim Investigational Site
city: St Etienne cedex 2
country: France
facility: 1160.25.03309 Boehringer Ingelheim Investigational Site
city: Strasbourg cedex 2
country: France
facility: 1160.25.03308 Boehringer Ingelheim Investigational Site
city: Bad Mergentheim
country: Germany
facility: 1160.25.04906 Caritaskrankenhaus
city: Erlangen
country: Germany
facility: 1160.25.04910 F.-A.-Universität Erlangen-Nürnberg
city: Frankfurt
country: Germany
facility: 1160.25.04904 Orthopädische Universitätsklinik
city: Garmisch-Partenkirchen
country: Germany
facility: 1160.25.04902 Klinikum Garmisch-Partenkirchen
city: Halle/Saale
country: Germany
facility: 1160.25.04911 Martin-Luther-Universität Halle-Wittenberg
city: Markgröningen
country: Germany
facility: 1160.25.04912 Orthopädische Klinik Markgröningen gGmbH
city: Rheinfelden
country: Germany
facility: 1160.25.04901 Kreiskrankenhaus
city: Sommerfeld
country: Germany
facility: 1160.25.04903 Hellmuth-Ulrici-Kliniken
city: Wiesbaden
country: Germany
facility: 1160.25.04905 Aukammklinik
city: Budapest
country: Hungary
facility: 1160.25.03603 Boehringer Ingelheim Investigational Site
city: Békéscsaba
country: Hungary
facility: 1160.25.03607 Boehringer Ingelheim Investigational Site
city: Gyula
country: Hungary
facility: 1160.25.03601 Boehringer Ingelheim Investigational Site
city: Kecskemét
country: Hungary
facility: 1160.25.03604 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 1160.25.03602 Boehringer Ingelheim Investigational Site
city: Székesfehérvár
country: Hungary
facility: 1160.25.03605 Boehringer Ingelheim Investigational Site
city: Bologna
country: Italy
facility: 1160.25.03906 Boehringer Ingelheim Investigational Site
city: Parma
country: Italy
facility: 1160.25.03905 Boehringer Ingelheim Investigational Site
city: Pavia
country: Italy
facility: 1160.25.03901 Boehringer Ingelheim Investigational Site
city: Piacenza
country: Italy
facility: 1160.25.03903 Boehringer Ingelheim Investigational Site
city: Reggio Emilia
country: Italy
facility: 1160.25.03904 Boehringer Ingelheim Investigational Site
city: Treviso
country: Italy
facility: 1160.25.03902 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.25.03102 Boehringer Ingelheim Investigational Site
city: Hilversum
country: Netherlands
facility: 1160.25.03103 Boehringer Ingelheim Investigational Site
city: Hoofddorp
country: Netherlands
facility: 1160.25.03101 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 1160.25.03104 Boehringer Ingelheim Investigational Site
city: Sittard
country: Netherlands
facility: 1160.25.03105 Boehringer Ingelheim Investigational Site
city: Zwolle
country: Netherlands
facility: 1160.25.03106 Boehringer Ingelheim Investigational Site
city: Kielce
country: Poland
facility: 1160.25.04804 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1160.25.04806 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1160.25.04807 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1160.25.04803 Boehringer Ingelheim Investigational Site
city: Bryanston
country: South Africa
facility: 1160.25.02701 Boehringer Ingelheim Investigational Site
city: Randburg
country: South Africa
facility: 1160.25.02703 Boehringer Ingelheim Investigational Site
city: Sandton
country: South Africa
facility: 1160.25.02702 Boehringer Ingelheim Investigational Site
city: Alcorcón (Madrid)
country: Spain
facility: 1160.25.03405 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.25.03403 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.25.03411 Boehringer Ingelheim Investigational Site
city: Hospitalet (Barcelona)
country: Spain
facility: 1160.25.03407 Boehringer Ingelheim Investigational Site
city: Jaén
country: Spain
facility: 1160.25.03409 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.25.03401 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.25.03402 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.25.03404 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.25.03406 Boehringer Ingelheim Investigational Site
city: Móstoles (Madrid)
country: Spain
facility: 1160.25.03408 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1160.25.03410 Boehringer Ingelheim Investigational Site
city: Falköping
country: Sweden
facility: 1160.25.04602 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.25.04601 Boehringer Ingelheim Investigational Site
city: Halmstad
country: Sweden
facility: 1160.25.04607 Boehringer Ingelheim Investigational Site
city: Kungälv
country: Sweden
facility: 1160.25.04603 Boehringer Ingelheim Investigational Site
city: Lidköping
country: Sweden
facility: 1160.25.04608 Boehringer Ingelheim Investigational Site
city: Linköping
country: Sweden
facility: 1160.25.04605 Boehringer Ingelheim Investigational Site
city: Mölndal
country: Sweden
facility: 1160.25.04604 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.25.04610 Boehringer Ingelheim Investigational Site
city: Varberg
country: Sweden
facility: 1160.25.04609 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.