Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
- Conditions
- Venous Thromboembolism
- Interventions
- Registration Number
- NCT00657150
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2055
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enoxaparin Enoxaparin 40 mg once daily Dabigatran etexilate Dabigatran etexilate 220 mg once daily
- Primary Outcome Measures
Name Time Method Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period 28-35 days Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, 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 Pulmonary Embolism During Treatment Period 28-35 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 28-35 days All cause death, as adjudicated by the VTE events committee
Number of Participants With Total Deep Vein Thrombosis During Treatment Period 28-35 days Total 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 28-35 days Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period 28-35 days Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period 28-35 days Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and 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 venography), symptomatic DVT (confirmed by venous duplex, 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 28-35 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 \>=25 cm²
* wound hematoma \>=100 cm²
* spontaneous nose bleed \>5 min
* macroscopic hematuria spontaneous or \>24 hours if associated with an intervention
* spontaneous rectal bleeding
* gingival bleeding \>5 min
* any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.Blood Transfusion Day 1 Number of treated and operated patients with required blood transfusion on day of surgery.
Laboratory Analyses First administration to end of study Frequency of patients with possible clinically significant abnormalities.
Trial Locations
- Locations (108)
1160.64.01003 Boehringer Ingelheim Investigational Site
🇺🇸Missoula, Montana, United States
1160.64.01002 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1160.64.6011 Boehringer Ingelheim Investigational Site
🇨🇦Oshawa, Ontario, Canada
1160.64.1503 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.64.7004 Boehringer Ingelheim Investigational Site
🇨🇿Chomutov, Czech Republic
1160.64.7005 Boehringer Ingelheim Investigational Site
🇨🇿Jihlava, Czech Republic
1160.64.9108 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1160.64.9111 Boehringer Ingelheim Investigational Site
🇮🇳New Delhi, India
1160.64.1601 Boehringer Ingelheim Investigational Site
🇳🇴Bodø, Norway
1160.64.4002 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1160.64.1604 Boehringer Ingelheim Investigational Site
🇳🇴Lillehammer, Norway
1160.64.9105 Boehringer Ingelheim Investigational Site
🇮🇳Ahmedabad, India
1160.64.9110 Boehringer Ingelheim Investigational Site
🇮🇳Mangalore, India
1160.64.7002 Boehringer Ingelheim Investigational Site
🇨🇿Prague 8, Czech Republic
1160.64.9102 Boehringer Ingelheim Investigational Site
🇮🇳Secunderabad, India
1160.64.1603 Boehringer Ingelheim Investigational Site
🇳🇴Ålesund, Norway
1160.64.9106 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1160.64.1606 Boehringer Ingelheim Investigational Site
🇳🇴Elverum, Norway
1160.64.7003 Boehringer Ingelheim Investigational Site
🇨🇿Kolin, Czech Republic
1160.64.7001 Boehringer Ingelheim Investigational Site
🇨🇿Plzen, Czech Republic
1160.64.1101 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1160.64.4001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.64.01005 Boehringer Ingelheim Investigational Site
🇺🇸La Jolla, California, United States
1160.64.4004 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
1160.64.9002 Boehringer Ingelheim Investigational Site
🇫🇮Jyväskylä, Finland
1160.64.9001 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
1160.64.9003 Boehringer Ingelheim Investigational Site
🇫🇮Tampere, Finland
1160.64.9103 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1160.64.1104 Boehringer Ingelheim Investigational Site
🇩🇪Garmisch-Partenkirchen, Germany
1160.64.1201 Boehringer Ingelheim Investigational Site
🇭🇺Gyula, Hungary
1160.64.1203 Boehringer Ingelheim Investigational Site
🇭🇺Kecskemét, Hungary
1160.64.9109 Boehringer Ingelheim Investigational Site
🇮🇳Andhra Predesh, India
1160.64.9107 Boehringer Ingelheim Investigational Site
🇮🇳Baroda, India
1160.64.9104 Boehringer Ingelheim Investigational Site
🇮🇳Mohali, India
1160.64.9101 Boehringer Ingelheim Investigational Site
🇮🇳Ramdaspeth Nagpur, India
1160.64.9113 Boehringer Ingelheim Investigational Site
🇮🇳Vadodara, India
1160.64.1507 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1160.64.1506 Boehringer Ingelheim Investigational Site
🇳🇱Hoofddorp, Netherlands
1160.64.2101 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.64.1901 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.64.1403 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1160.64.1905 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1160.64.1501 Boehringer Ingelheim Investigational Site
🇳🇱Hilversum, Netherlands
1160.64.1508 Boehringer Ingelheim Investigational Site
🇳🇱Zwolle, Netherlands
1160.64.1510 Boehringer Ingelheim Investigational Site
🇳🇱Leiden, Netherlands
1160.64.2109 Boehringer Ingelheim Investigational Site
🇸🇪Kalmar, Sweden
1160.64.1402 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1160.64.2108 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.64.1605 Boehringer Ingelheim Investigational Site
🇳🇴Tynset, Norway
1160.64.1907 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1160.64.8004 Boehringer Ingelheim Investigational Site
🇩🇰Frederiksberg, Denmark
1160.64.8003 Boehringer Ingelheim Investigational Site
🇩🇰Herlev, Denmark
1160.64.8001 Boehringer Ingelheim Investigational Site
🇩🇰Hørsholm, Denmark
1160.64.8002 Boehringer Ingelheim Investigational Site
🇩🇰Silkeborg, Denmark
1160.64.1401 Boehringer Ingelheim Investigational Site
🇮🇹Bologna, Italy
1160.64.6004 Boehringer Ingelheim Investigational Site
🇨🇦Cambridge, Ontario, Canada
1160.64.1202 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
1160.64.01010 Boehringer Ingelheim Investigational Site
🇺🇸Aurora, Colorado, United States
1160.64.01009 Boehringer Ingelheim Investigational Site
🇺🇸Englewood, Colorado, United States
1160.64.01012 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
1160.64.01006 Boehringer Ingelheim Investigational Site
🇺🇸Lexington, Kentucky, United States
1160.64.01013 Boehringer Ingelheim Investigational Site
🇺🇸Conway, South Carolina, United States
1160.64.01007 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
1160.64.2003 Boehringer Ingelheim Investigational Site
🇦🇺Daws Park, South Australia, Australia
1160.64.01011 Boehringer Ingelheim Investigational Site
🇺🇸Spokane, Washington, United States
1160.64.2002 Boehringer Ingelheim Investigational Site
🇦🇺Box HIll, Victoria, Australia
1160.64.2001 Boehringer Ingelheim Investigational Site
🇦🇺Windsor, Victoria, Australia
1160.64.2004 Boehringer Ingelheim Investigational Site
🇦🇺Nedlands, Western Australia, Australia
1160.64.4003 Boehringer Ingelheim Investigational Site
🇦🇹Wels, Austria
1160.64.5004 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
1160.64.5005 Boehringer Ingelheim Investigational Site
🇧🇪Lanaken, Belgium
1160.64.5001 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1160.64.6009 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton,, Alberta, Canada
1160.64.6002 Boehringer Ingelheim Investigational Site
🇨🇦Red Deer, Alberta, Canada
1160.64.6003 Boehringer Ingelheim Investigational Site
🇨🇦Belleville, Ontario, Canada
1160.64.6012 Boehringer Ingelheim Investigational Site
🇨🇦Ajax, Ontario, Canada
1160.64.6008 Boehringer Ingelheim Investigational Site
🇨🇦Kitchener, Ontario, Canada
1160.64.6005 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1160.64.6007 Boehringer Ingelheim Investigational Site
🇨🇦Stratford, Ontario, Canada
1160.64.6013 Boehringer Ingelheim Investigational Site
🇨🇦Windsor, Ontario, Canada
1160.64.1102 Boehringer Ingelheim Investigational Site
🇩🇪Rheinfelden, Germany
1160.64.1103 Boehringer Ingelheim Investigational Site
🇩🇪Markgröningen, Germany
1160.64.1204 Boehringer Ingelheim Investigational Site
🇭🇺Székesfehérvár, Hungary
1160.64.9112 Boehringer Ingelheim Investigational Site
🇮🇳Andhra Pradesh, India
1160.64.1405 Boehringer Ingelheim Investigational Site
🇮🇹Parma, Italy
1160.64.1505 Boehringer Ingelheim Investigational Site
🇳🇱Sittard, Netherlands
1160.64.1407 Boehringer Ingelheim Investigational Site
🇮🇹Reggio Emilia, Italy
1160.64.1404 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1160.64.3001 Boehringer Ingelheim Investigational Site
🇳🇿Takapuna Auckland, New Zealand
1160.64.1702 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.64.1703 Boehringer Ingelheim Investigational Site
🇵🇱Piekary Slaskie, Poland
1160.64.1704 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
1160.64.1804 Boehringer Ingelheim Investigational Site
🇿🇦Cape Western Province, South Africa
1160.64.1701 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.64.1801 Boehringer Ingelheim Investigational Site
🇿🇦Bryanston, South Africa
1160.64.1802 Boehringer Ingelheim Investigational Site
🇿🇦Plumstead, South Africa
1160.64.1904 Boehringer Ingelheim Investigational Site
🇪🇸Alcorcón (Madrid), Spain
1160.64.1906 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1160.64.1908 Boehringer Ingelheim Investigational Site
🇪🇸Fuenlabrada, Spain
1160.64.2102 Boehringer Ingelheim Investigational Site
🇸🇪Motala, Sweden
1160.64.2112 Boehringer Ingelheim Investigational Site
🇸🇪Halmstad, Sweden
1160.64.2105 Boehringer Ingelheim Investigational Site
🇸🇪Hässleholm, Sweden
1160.64.2103 Boehringer Ingelheim Investigational Site
🇸🇪Kungälv, Sweden
1160.64.2106 Boehringer Ingelheim Investigational Site
🇸🇪Lidköping, Sweden
1160.64.2107 Boehringer Ingelheim Investigational Site
🇸🇪Varberg, Sweden
1160.64.2111 Boehringer Ingelheim Investigational Site
🇸🇪Uppsala, Sweden
1160.64.1705 Boehringer Ingelheim Investigational Site
🇵🇱Lodz, Poland
1160.64.5002 Boehringer Ingelheim Investigational Site
🇧🇪Deurne, Belgium