Please note that due to a high volume of submissions, the ANZCTR is currently experiencing a delay in processing of submissions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00168805




Registration number
NCT00168805
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
19/05/2014

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2004-001317-34
Secondary ID [2] 0 0
1160.25
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee 0 0
Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - enoxaparin
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - dabigatran etexilate

Experimental: dabigatran etexilate 220 mg - 220 mg once daily

Experimental: dabigatran etexilate 150 mg - 150 mg once daily

Active Comparator: enoxaparin - 40 mg once daily


Treatment: Drugs: enoxaparin
40 mg once daily

Treatment: Drugs: dabigatran etexilate
150 mg once daily

Treatment: Drugs: dabigatran etexilate
220 mg once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
First administration until 6-10 days
Secondary outcome [1] 0 0
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period - Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Timepoint [1] 0 0
First administration until 6-10 days
Secondary outcome [2] 0 0
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period - Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Timepoint [2] 0 0
First administration until 6-10 days
Secondary outcome [3] 0 0
Number of Participants With Total Deep Vein Thrombosis During Treatment Period - Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Timepoint [3] 0 0
First administration until 6-10 days
Secondary outcome [4] 0 0
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period - Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Timepoint [4] 0 0
First administration until 6-10 days
Secondary outcome [5] 0 0
Number of Participants With Pulmonary Embolism During Treatment Period - Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Timepoint [5] 0 0
First administration until 6-10 days
Secondary outcome [6] 0 0
Number of Participants Who Died During Treatment Period - All cause death, as adjudicated by the VTE events committee
Timepoint [6] 0 0
First administration until 6-10 days
Secondary outcome [7] 0 0
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up 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).
Timepoint [7] 0 0
3 months
Secondary outcome [8] 0 0
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period - Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma greater than or equal to 25 cm²
wound hematoma greater than or equal to 100 cm²
spontaneous nose bleed lasting longer than 5 min
macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding lasting longer than 5 min
any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Timepoint [8] 0 0
First administration until 6-10 days
Secondary outcome [9] 0 0
Blood Transfusion - Blood transfusion for treated and operated patients on Day of surgery.
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Volume of Blood Loss - Volume of blood loss for treated and operated patients during surgery.
Timepoint [10] 0 0
Day 1
Secondary outcome [11] 0 0
Laboratory Analyses - Frequency of patients with possible clinically significant abnormalities.
Timepoint [11] 0 0
First administration to end of study

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
1160.25.06108 Boehringer Ingelheim Investigational Site - Garren
Recruitment hospital [2] 0 0
1160.25.06106 Boehringer Ingelheim Investigational Site - Kogarah
Recruitment hospital [3] 0 0
1160.25.06110 Boehringer Ingelheim Investigational Site - Lismore
Recruitment hospital [4] 0 0
1160.25.06105 Boehringer Ingelheim Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
1160.25.06107 Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [6] 0 0
1160.25.06109 Boehringer Ingelheim Investigational Site - Woodville
Recruitment hospital [7] 0 0
1160.25.06104 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
1160.25.06102 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [9] 0 0
1160.25.06101 Boehringer Ingelheim Investigational Site - Malvern
Recruitment hospital [10] 0 0
1160.25.06103 Boehringer Ingelheim Investigational Site - Ringwood East
Recruitment hospital [11] 0 0
1160.25.06113 Boehringer Ingelheim Investigational Site - Windsor
Recruitment hospital [12] 0 0
1160.25.06111 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Garren
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Lismore
Recruitment postcode(s) [4] 0 0
- Bedford Park
Recruitment postcode(s) [5] 0 0
- Toorak Gardens
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
- Clayton
Recruitment postcode(s) [9] 0 0
- Malvern
Recruitment postcode(s) [10] 0 0
- Ringwood East
Recruitment postcode(s) [11] 0 0
- Windsor
Recruitment postcode(s) [12] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Wels
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Austria
State/province [4] 0 0
Wr. Neustadt
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Genk
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Hasselt
Country [9] 0 0
Belgium
State/province [9] 0 0
Herentals
Country [10] 0 0
Belgium
State/province [10] 0 0
Lanaken
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Brno-Bohunice
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Chomutov
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Havlickuv Brod
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Kladno
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Kolin
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Ostrava
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Plzen
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Pradubice
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Prague 8
Country [21] 0 0
Denmark
State/province [21] 0 0
Hellerup
Country [22] 0 0
Denmark
State/province [22] 0 0
Hørsholm
Country [23] 0 0
Denmark
State/province [23] 0 0
København NV
Country [24] 0 0
Denmark
State/province [24] 0 0
København S
Country [25] 0 0
Denmark
State/province [25] 0 0
Silkeborg
Country [26] 0 0
Finland
State/province [26] 0 0
Helsinki
Country [27] 0 0
Finland
State/province [27] 0 0
Jyväskylä
Country [28] 0 0
Finland
State/province [28] 0 0
Oulu
Country [29] 0 0
Finland
State/province [29] 0 0
Seinäjoki
Country [30] 0 0
France
State/province [30] 0 0
Amiens cedex 1
Country [31] 0 0
France
State/province [31] 0 0
Annecy
Country [32] 0 0
France
State/province [32] 0 0
La Rochelle
Country [33] 0 0
France
State/province [33] 0 0
Paris cedex 14
Country [34] 0 0
France
State/province [34] 0 0
Poitiers cedex
Country [35] 0 0
France
State/province [35] 0 0
Roubaix cedex
Country [36] 0 0
France
State/province [36] 0 0
Soyaux
Country [37] 0 0
France
State/province [37] 0 0
St Etienne cedex 2
Country [38] 0 0
France
State/province [38] 0 0
Strasbourg cedex 2
Country [39] 0 0
Germany
State/province [39] 0 0
Bad Mergentheim
Country [40] 0 0
Germany
State/province [40] 0 0
Erlangen
Country [41] 0 0
Germany
State/province [41] 0 0
Frankfurt
Country [42] 0 0
Germany
State/province [42] 0 0
Garmisch-Partenkirchen
Country [43] 0 0
Germany
State/province [43] 0 0
Halle/Saale
Country [44] 0 0
Germany
State/province [44] 0 0
Markgröningen
Country [45] 0 0
Germany
State/province [45] 0 0
Rheinfelden
Country [46] 0 0
Germany
State/province [46] 0 0
Sommerfeld
Country [47] 0 0
Germany
State/province [47] 0 0
Wiesbaden
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Békéscsaba
Country [50] 0 0
Hungary
State/province [50] 0 0
Gyula
Country [51] 0 0
Hungary
State/province [51] 0 0
Kecskemét
Country [52] 0 0
Hungary
State/province [52] 0 0
Szeged
Country [53] 0 0
Hungary
State/province [53] 0 0
Székesfehérvár
Country [54] 0 0
Italy
State/province [54] 0 0
Bologna
Country [55] 0 0
Italy
State/province [55] 0 0
Parma
Country [56] 0 0
Italy
State/province [56] 0 0
Pavia
Country [57] 0 0
Italy
State/province [57] 0 0
Piacenza
Country [58] 0 0
Italy
State/province [58] 0 0
Reggio Emilia
Country [59] 0 0
Italy
State/province [59] 0 0
Treviso
Country [60] 0 0
Netherlands
State/province [60] 0 0
Amsterdam
Country [61] 0 0
Netherlands
State/province [61] 0 0
Hilversum
Country [62] 0 0
Netherlands
State/province [62] 0 0
Hoofddorp
Country [63] 0 0
Netherlands
State/province [63] 0 0
Nijmegen
Country [64] 0 0
Netherlands
State/province [64] 0 0
Sittard
Country [65] 0 0
Netherlands
State/province [65] 0 0
Zwolle
Country [66] 0 0
Poland
State/province [66] 0 0
Kielce
Country [67] 0 0
Poland
State/province [67] 0 0
Krakow
Country [68] 0 0
Poland
State/province [68] 0 0
Warsaw
Country [69] 0 0
South Africa
State/province [69] 0 0
Bryanston
Country [70] 0 0
South Africa
State/province [70] 0 0
Randburg
Country [71] 0 0
South Africa
State/province [71] 0 0
Sandton
Country [72] 0 0
Spain
State/province [72] 0 0
Alcorcón (Madrid)
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
Country [74] 0 0
Spain
State/province [74] 0 0
Hospitalet (Barcelona)
Country [75] 0 0
Spain
State/province [75] 0 0
Jaén
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Spain
State/province [77] 0 0
Móstoles (Madrid)
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Sweden
State/province [79] 0 0
Falköping
Country [80] 0 0
Sweden
State/province [80] 0 0
Göteborg
Country [81] 0 0
Sweden
State/province [81] 0 0
Halmstad
Country [82] 0 0
Sweden
State/province [82] 0 0
Kungälv
Country [83] 0 0
Sweden
State/province [83] 0 0
Lidköping
Country [84] 0 0
Sweden
State/province [84] 0 0
Linköping
Country [85] 0 0
Sweden
State/province [85] 0 0
Mölndal
Country [86] 0 0
Sweden
State/province [86] 0 0
Stockholm
Country [87] 0 0
Sweden
State/province [87] 0 0
Varberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT00168805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications