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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00168805
Other study ID # 1160.25
Secondary ID 2004-001317-34
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated May 8, 2014
Start date November 2004

Study information

Verified date February 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia:Austria:Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic:Denmark:Finland:France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)Germany:Hungary:Italy: Comitato di Bioetica IRCCS Policlinico San Matteo Viale Golgi, 19 - 27100 PAVIANetherlands:Poland:South Africa:Spain:Sweden:
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 2101
Est. completion date
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
enoxaparin
40 mg once daily
dabigatran etexilate
150 mg once daily
dabigatran etexilate
220 mg once daily

Locations

Country Name City State
Australia 1160.25.06105 Boehringer Ingelheim Investigational Site Bedford Park South Australia
Australia 1160.25.06104 Boehringer Ingelheim Investigational Site Box Hill Victoria
Australia 1160.25.06102 Boehringer Ingelheim Investigational Site Clayton Victoria
Australia 1160.25.06108 Boehringer Ingelheim Investigational Site Garren Australian Capital Territory
Australia 1160.25.06106 Boehringer Ingelheim Investigational Site Kogarah New South Wales
Australia 1160.25.06110 Boehringer Ingelheim Investigational Site Lismore New South Wales
Australia 1160.25.06101 Boehringer Ingelheim Investigational Site Malvern Victoria
Australia 1160.25.06111 Boehringer Ingelheim Investigational Site Perth Western Australia
Australia 1160.25.06103 Boehringer Ingelheim Investigational Site Ringwood East Victoria
Australia 1160.25.06107 Boehringer Ingelheim Investigational Site Toorak Gardens South Australia
Australia 1160.25.06113 Boehringer Ingelheim Investigational Site Windsor Victoria
Australia 1160.25.06109 Boehringer Ingelheim Investigational Site Woodville South Australia
Austria 1160.25.04304 Boehringer Ingelheim Investigational Site Linz
Austria 1160.25.04303 Boehringer Ingelheim Investigational Site Wels
Austria 1160.25.04302 Boehringer Ingelheim Investigational Site Wien
Austria 1160.25.04301 Boehringer Ingelheim Investigational Site Wr. Neustadt
Belgium 1160.25.03207 UVC Brugmann Brussels
Belgium 1160.25.03209 ZOL St. Jan Genk
Belgium 1160.25.03206 Campus Sint-Lucas Gent
Belgium 1160.25.03208 UZ Gent Gent
Belgium 1160.25.03202 Virga Jesseziekenhuis Hasselt
Belgium 1160.25.03203 AZ Sint Elisabeth Herentals
Belgium 1160.25.03205 Ziekenhuis Oost-Limburg Lanaken
Belgium 1160.25.03201 UZ Gasthuisberg Leuven
Czech Republic 1160.25.42004 Boehringer Ingelheim Investigational Site Brno-Bohunice
Czech Republic 1160.25.42010 Boehringer Ingelheim Investigational Site Chomutov
Czech Republic 1160.25.42009 Boehringer Ingelheim Investigational Site Havlickuv Brod
Czech Republic 1160.25.42002 Boehringer Ingelheim Investigational Site Kladno
Czech Republic 1160.25.42006 Boehringer Ingelheim Investigational Site Kolin
Czech Republic 1160.25.42003 Boehringer Ingelheim Investigational Site Ostrava
Czech Republic 1160.25.42001 Boehringer Ingelheim Investigational Site Plzen
Czech Republic 1160.25.42007 Boehringer Ingelheim Investigational Site Pradubice
Czech Republic 1160.25.42005 Boehringer Ingelheim Investigational Site Prague 8
Denmark 1160.25.04571 Boehringer Ingelheim Investigational Site Hellerup
Denmark 1160.25.04570 Boehringer Ingelheim Investigational Site Hørsholm
Denmark 1160.25.04573 Boehringer Ingelheim Investigational Site København NV
Denmark 1160.25.04574 Boehringer Ingelheim Investigational Site København S
Denmark 1160.25.04575 Boehringer Ingelheim Investigational Site Silkeborg
Finland 1160.25.35803 Boehringer Ingelheim Investigational Site Helsinki
Finland 1160.25.35802 Boehringer Ingelheim Investigational Site Jyväskylä
Finland 1160.25.35801 Boehringer Ingelheim Investigational Site Oulu
Finland 1160.25.35804 Boehringer Ingelheim Investigational Site Seinäjoki
France 1160.25.03304 Boehringer Ingelheim Investigational Site Amiens cedex 1
France 1160.25.03307 Boehringer Ingelheim Investigational Site Annecy
France 1160.25.03305 Boehringer Ingelheim Investigational Site La Rochelle
France 1160.25.03301 Boehringer Ingelheim Investigational Site Paris cedex 14
France 1160.25.03306 Boehringer Ingelheim Investigational Site Poitiers cedex
France 1160.25.03303 Boehringer Ingelheim Investigational Site Roubaix cedex
France 1160.25.03302 Boehringer Ingelheim Investigational Site Soyaux
France 1160.25.03309 Boehringer Ingelheim Investigational Site St Etienne cedex 2
France 1160.25.03308 Boehringer Ingelheim Investigational Site Strasbourg cedex 2
Germany 1160.25.04906 Caritaskrankenhaus Bad Mergentheim
Germany 1160.25.04910 F.-A.-Universität Erlangen-Nürnberg Erlangen
Germany 1160.25.04904 Orthopädische Universitätsklinik Frankfurt
Germany 1160.25.04902 Klinikum Garmisch-Partenkirchen Garmisch-Partenkirchen
Germany 1160.25.04911 Martin-Luther-Universität Halle-Wittenberg Halle/Saale
Germany 1160.25.04912 Orthopädische Klinik Markgröningen gGmbH Markgröningen
Germany 1160.25.04901 Kreiskrankenhaus Rheinfelden
Germany 1160.25.04903 Hellmuth-Ulrici-Kliniken Sommerfeld
Germany 1160.25.04905 Aukammklinik Wiesbaden
Hungary 1160.25.03607 Boehringer Ingelheim Investigational Site Békéscsaba
Hungary 1160.25.03603 Boehringer Ingelheim Investigational Site Budapest
Hungary 1160.25.03601 Boehringer Ingelheim Investigational Site Gyula
Hungary 1160.25.03604 Boehringer Ingelheim Investigational Site Kecskemét
Hungary 1160.25.03602 Boehringer Ingelheim Investigational Site Szeged
Hungary 1160.25.03605 Boehringer Ingelheim Investigational Site Székesfehérvár
Italy 1160.25.03906 Boehringer Ingelheim Investigational Site Bologna
Italy 1160.25.03905 Boehringer Ingelheim Investigational Site Parma
Italy 1160.25.03901 Boehringer Ingelheim Investigational Site Pavia
Italy 1160.25.03903 Boehringer Ingelheim Investigational Site Piacenza
Italy 1160.25.03904 Boehringer Ingelheim Investigational Site Reggio Emilia
Italy 1160.25.03902 Boehringer Ingelheim Investigational Site Treviso
Netherlands 1160.25.03102 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1160.25.03103 Boehringer Ingelheim Investigational Site Hilversum
Netherlands 1160.25.03101 Boehringer Ingelheim Investigational Site Hoofddorp
Netherlands 1160.25.03104 Boehringer Ingelheim Investigational Site Nijmegen
Netherlands 1160.25.03105 Boehringer Ingelheim Investigational Site Sittard
Netherlands 1160.25.03106 Boehringer Ingelheim Investigational Site Zwolle
Poland 1160.25.04804 Boehringer Ingelheim Investigational Site Kielce
Poland 1160.25.04806 Boehringer Ingelheim Investigational Site Krakow
Poland 1160.25.04807 Boehringer Ingelheim Investigational Site Krakow
Poland 1160.25.04803 Boehringer Ingelheim Investigational Site Warsaw
South Africa 1160.25.02701 Boehringer Ingelheim Investigational Site Bryanston
South Africa 1160.25.02703 Boehringer Ingelheim Investigational Site Randburg
South Africa 1160.25.02702 Boehringer Ingelheim Investigational Site Sandton
Spain 1160.25.03405 Boehringer Ingelheim Investigational Site Alcorcón (Madrid)
Spain 1160.25.03403 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.25.03411 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.25.03407 Boehringer Ingelheim Investigational Site Hospitalet (Barcelona)
Spain 1160.25.03409 Boehringer Ingelheim Investigational Site Jaén
Spain 1160.25.03401 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.25.03402 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.25.03404 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.25.03406 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.25.03408 Boehringer Ingelheim Investigational Site Móstoles (Madrid)
Spain 1160.25.03410 Boehringer Ingelheim Investigational Site Valencia
Sweden 1160.25.04602 Boehringer Ingelheim Investigational Site Falköping
Sweden 1160.25.04601 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1160.25.04607 Boehringer Ingelheim Investigational Site Halmstad
Sweden 1160.25.04603 Boehringer Ingelheim Investigational Site Kungälv
Sweden 1160.25.04608 Boehringer Ingelheim Investigational Site Lidköping
Sweden 1160.25.04605 Boehringer Ingelheim Investigational Site Linköping
Sweden 1160.25.04604 Boehringer Ingelheim Investigational Site Mölndal
Sweden 1160.25.04610 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.25.04609 Boehringer Ingelheim Investigational Site Varberg

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 First administration until 6-10 days No
Secondary Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee First administration until 6-10 days No
Secondary Number of Participants With Total Deep Vein Thrombosis During Treatment Period Total Deep Vein Thrombosis as adjudicated by the VTE events committee First administration until 6-10 days No
Secondary 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 First administration until 6-10 days No
Secondary 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 First administration until 6-10 days No
Secondary Number of Participants Who Died During Treatment Period All cause death, as adjudicated by the VTE events committee First administration until 6-10 days No
Secondary 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). 3 months No
Secondary 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.
First administration until 6-10 days Yes
Secondary Blood Transfusion Blood transfusion for treated and operated patients on Day of surgery. Day 1 No
Secondary Volume of Blood Loss Volume of blood loss for treated and operated patients during surgery. Day 1 No
Secondary Laboratory Analyses Frequency of patients with possible clinically significant abnormalities. First administration to end of study No
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