Arthroplasty, Replacement, Knee Clinical Trial
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
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)
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden,
| 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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