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
- Conditions
- Arthroplasty, Replacement, KneeThromboembolism
- Interventions
- Registration Number
- NCT00168805
- Lead Sponsor
- Boehringer Ingelheim
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2101
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dabigatran etexilate 220 mg dabigatran etexilate 220 mg once daily dabigatran etexilate 150 mg dabigatran etexilate 150 mg once daily enoxaparin enoxaparin 40 mg once daily
- Primary Outcome Measures
Name Time Method Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period First administration until 6-10 days 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.
- Secondary Outcome Measures
Name Time Method Volume of Blood Loss Day 1 Volume of blood loss for treated and operated patients during surgery.
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period First administration until 6-10 days Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period First administration until 6-10 days Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Number of Participants With Total Deep Vein Thrombosis During Treatment Period First administration until 6-10 days Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period First administration until 6-10 days Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Number of Participants With Pulmonary Embolism During Treatment Period First administration until 6-10 days 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
Number of Participants Who Died During Treatment Period First administration until 6-10 days All cause death, as adjudicated by the VTE events committee
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period 3 months 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).
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period First administration until 6-10 days 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.Blood Transfusion Day 1 Blood transfusion for treated and operated patients on Day of surgery.
Laboratory Analyses First administration to end of study Frequency of patients with possible clinically significant abnormalities.
Trial Locations
- Locations (105)
1160.25.06103 Boehringer Ingelheim Investigational Site
🇦🇺Ringwood East, Victoria, Australia
1160.25.04303 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
1160.25.42010 Boehringer Ingelheim Investigational Site
🇨🇿Chomutov, Czech Republic
1160.25.42002 Boehringer Ingelheim Investigational Site
🇨🇿Kladno, Czech Republic
1160.25.35801 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
1160.25.03605 Boehringer Ingelheim Investigational Site
🇭🇺Székesfehérvár, Hungary
1160.25.03103 Boehringer Ingelheim Investigational Site
🇳🇱Hilversum, Netherlands
1160.25.03101 Boehringer Ingelheim Investigational Site
🇳🇱Hoofddorp, Netherlands
1160.25.03106 Boehringer Ingelheim Investigational Site
🇳🇱Zwolle, Netherlands
1160.25.04911 Martin-Luther-Universität Halle-Wittenberg
🇩🇪Halle/Saale, Germany
1160.25.04912 Orthopädische Klinik Markgröningen gGmbH
🇩🇪Markgröningen, Germany
1160.25.04910 F.-A.-Universität Erlangen-Nürnberg
🇩🇪Erlangen, Germany
1160.25.03309 Boehringer Ingelheim Investigational Site
🇫🇷St Etienne cedex 2, France
1160.25.03601 Boehringer Ingelheim Investigational Site
🇭🇺Gyula, Hungary
1160.25.04906 Caritaskrankenhaus
🇩🇪Bad Mergentheim, Germany
1160.25.03403 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.25.03603 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1160.25.04607 Boehringer Ingelheim Investigational Site
🇸🇪Halmstad, Sweden
1160.25.04604 Boehringer Ingelheim Investigational Site
🇸🇪Mölndal, Sweden
1160.25.04609 Boehringer Ingelheim Investigational Site
🇸🇪Varberg, Sweden
1160.25.02703 Boehringer Ingelheim Investigational Site
🇿🇦Randburg, South Africa
1160.25.02702 Boehringer Ingelheim Investigational Site
🇿🇦Sandton, South Africa
1160.25.03408 Boehringer Ingelheim Investigational Site
🇪🇸Móstoles (Madrid), Spain
1160.25.04902 Klinikum Garmisch-Partenkirchen
🇩🇪Garmisch-Partenkirchen, Germany
1160.25.03604 Boehringer Ingelheim Investigational Site
🇭🇺Kecskemét, Hungary
1160.25.03602 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
1160.25.04608 Boehringer Ingelheim Investigational Site
🇸🇪Lidköping, Sweden
1160.25.04610 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.25.04903 Hellmuth-Ulrici-Kliniken
🇩🇪Sommerfeld, Germany
1160.25.03411 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.25.03407 Boehringer Ingelheim Investigational Site
🇪🇸Hospitalet (Barcelona), Spain
1160.25.03401 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.25.03607 Boehringer Ingelheim Investigational Site
🇭🇺Békéscsaba, Hungary
1160.25.04803 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.25.03409 Boehringer Ingelheim Investigational Site
🇪🇸Jaén, Spain
1160.25.04901 Kreiskrankenhaus
🇩🇪Rheinfelden, Germany
1160.25.04905 Aukammklinik
🇩🇪Wiesbaden, Germany
1160.25.03102 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.25.03406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.25.03104 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
1160.25.03105 Boehringer Ingelheim Investigational Site
🇳🇱Sittard, Netherlands
1160.25.04804 Boehringer Ingelheim Investigational Site
🇵🇱Kielce, Poland
1160.25.04603 Boehringer Ingelheim Investigational Site
🇸🇪Kungälv, Sweden
1160.25.04806 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.25.04602 Boehringer Ingelheim Investigational Site
🇸🇪Falköping, Sweden
1160.25.04601 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.25.02701 Boehringer Ingelheim Investigational Site
🇿🇦Bryanston, South Africa
1160.25.04571 Boehringer Ingelheim Investigational Site
🇩🇰Hellerup, Denmark
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, Italy
1160.25.03308 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg cedex 2, France
1160.25.03402 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.25.03404 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.25.03410 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1160.25.04904 Orthopädische Universitätsklinik
🇩🇪Frankfurt, Germany
1160.25.06108 Boehringer Ingelheim Investigational Site
🇦🇺Garren, Australian Capital Territory, Australia
1160.25.06105 Boehringer Ingelheim Investigational Site
🇦🇺Bedford Park, South Australia, Australia
1160.25.06110 Boehringer Ingelheim Investigational Site
🇦🇺Lismore, New South Wales, Australia
1160.25.06107 Boehringer Ingelheim Investigational Site
🇦🇺Toorak Gardens, South Australia, Australia
1160.25.06109 Boehringer Ingelheim Investigational Site
🇦🇺Woodville, South Australia, Australia
1160.25.06102 Boehringer Ingelheim Investigational Site
🇦🇺Clayton, Victoria, Australia
1160.25.06104 Boehringer Ingelheim Investigational Site
🇦🇺Box Hill, Victoria, Australia
1160.25.06101 Boehringer Ingelheim Investigational Site
🇦🇺Malvern, Victoria, Australia
1160.25.06111 Boehringer Ingelheim Investigational Site
🇦🇺Perth, Western Australia, Australia
1160.25.04304 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.25.06113 Boehringer Ingelheim Investigational Site
🇦🇺Windsor, Victoria, Australia
1160.25.03307 Boehringer Ingelheim Investigational Site
🇫🇷Annecy, France
1160.25.04301 Boehringer Ingelheim Investigational Site
🇦🇹Wr. Neustadt, Austria
1160.25.04302 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.25.03206 Campus Sint-Lucas
🇧🇪Gent, Belgium
1160.25.03208 UZ Gent
🇧🇪Gent, Belgium
1160.25.03209 ZOL St. Jan
🇧🇪Genk, Belgium
1160.25.03202 Virga Jesseziekenhuis
🇧🇪Hasselt, Belgium
1160.25.03207 UVC Brugmann
🇧🇪Brussels, Belgium
1160.25.03201 UZ Gasthuisberg
🇧🇪Leuven, Belgium
1160.25.03205 Ziekenhuis Oost-Limburg
🇧🇪Lanaken, Belgium
1160.25.42004 Boehringer Ingelheim Investigational Site
🇨🇿Brno-Bohunice, Czech Republic
1160.25.03203 AZ Sint Elisabeth
🇧🇪Herentals, Belgium
1160.25.42009 Boehringer Ingelheim Investigational Site
🇨🇿Havlickuv Brod, Czech Republic
1160.25.42006 Boehringer Ingelheim Investigational Site
🇨🇿Kolin, Czech Republic
1160.25.42005 Boehringer Ingelheim Investigational Site
🇨🇿Prague 8, Czech Republic
1160.25.42007 Boehringer Ingelheim Investigational Site
🇨🇿Pradubice, Czech Republic
1160.25.42003 Boehringer Ingelheim Investigational Site
🇨🇿Ostrava, Czech Republic
1160.25.42001 Boehringer Ingelheim Investigational Site
🇨🇿Plzen, Czech Republic
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
1160.25.03304 Boehringer Ingelheim Investigational Site
🇫🇷Amiens cedex 1, France
1160.25.35802 Boehringer Ingelheim Investigational Site
🇫🇮Jyväskylä, Finland
1160.25.35804 Boehringer Ingelheim Investigational Site
🇫🇮Seinäjoki, Finland
1160.25.04575 Boehringer Ingelheim Investigational Site
🇩🇰Silkeborg, Denmark
1160.25.35803 Boehringer Ingelheim Investigational Site
🇫🇮Helsinki, Finland
1160.25.03305 Boehringer Ingelheim Investigational Site
🇫🇷La Rochelle, France
1160.25.03306 Boehringer Ingelheim Investigational Site
🇫🇷Poitiers cedex, France
1160.25.03303 Boehringer Ingelheim Investigational Site
🇫🇷Roubaix cedex, France
1160.25.03301 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 14, France
1160.25.03302 Boehringer Ingelheim Investigational Site
🇫🇷Soyaux, France
1160.25.04807 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.25.03405 Boehringer Ingelheim Investigational Site
🇪🇸Alcorcón (Madrid), Spain
1160.25.04605 Boehringer Ingelheim Investigational Site
🇸🇪Linköping, Sweden
1160.25.06106 Boehringer Ingelheim Investigational Site
🇦🇺Kogarah, New South Wales, Australia