Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
- Conditions
- Venous Thromboembolism
- Interventions
- Drug: matching placebo twice daily (BID)
- Registration Number
- NCT00558259
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1353
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description matching placebo twice daily (BID) matching placebo twice daily (BID) Patient to receive dabigatran extexilate matching placebo capsules twice daily dabigatran etexilate 150 mg BID dabigatran etexilate 150 mg twice daily (BID) Patient to receive dabigatran etexilatate capsules 150 mg twice daily
- Primary Outcome Measures
Name Time Method Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period 6 months Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
- Secondary Outcome Measures
Name Time Method Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period 6 months Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period 6 months Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Laboratory Measures, Especially Liver Function Tests (LFTs) 6 months Number of participants with possible clinically significant abnormalities during the treatment period.
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period 6 months Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period 6 months Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Centrally Confirmed Bleeding Event During the Treatment Period 6 months Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:
* Fatal bleeding
* Associated with a fall in haemoglobin of ≥2 g/dL
* Led to the transfusion of ≥2 units packed cells or whole blood
* Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal
Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.
Examples of these bleedings were:
* Bleeding that compromised haemodynamics
* Bleeding that led to hospitalisation
Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.
All bleeding events include MBEs, CRBEs, and trivial bleeding events.Centrally Confirmed Cardiovascular Events During the Treatment Period 6 months Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Trial Locations
- Locations (147)
1160.63.01002 Boehringer Ingelheim Investigational Site
🇺🇸Laguna Hills, California, United States
1160.63.01020 Boehringer Ingelheim Investigational Site
🇺🇸Spartanburg, South Carolina, United States
1160.63.01032 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Ohio, United States
1160.63.41011 Boehringer Ingelheim Investigational Site
🇨🇭Bruderholz, Switzerland
1160.63.43006 Boehringer Ingelheim Investigational Site
🇦🇹Innsbruck, Austria
1160.63.37101 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
1160.63.37002 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
1160.63.31010 Boehringer Ingelheim Investigational Site
🇳🇱Assen, Netherlands
1160.63.07004 Boehringer Ingelheim Investigational Site
🇷🇺Kursk, Russian Federation
1160.63.31012 Boehringer Ingelheim Investigational Site
🇳🇱Dirksland, Netherlands
1160.63.07007 Boehringer Ingelheim Investigational Site
🇷🇺Ekaterinburg, Russian Federation
1160.63.07014 Boehringer Ingelheim Investigational Site
🇷🇺Ufa, Russian Federation
1160.63.41012 Boehringer Ingelheim Investigational Site
🇨🇭Basel, Switzerland
1160.63.41003 Boehringer Ingelheim Investigational Site
🇨🇭Cham, Switzerland
1160.63.41022 Boehringer Ingelheim Investigational Site
🇨🇭Wetzikon, Switzerland
1160.63.42002 Boehringer Ingelheim Investigational Site
🇨🇿Prague 4-Krc, Czech Republic
1160.63.42006 Boehringer Ingelheim Investigational Site
🇨🇿Praha 4, Czech Republic
1160.63.42007 Boehringer Ingelheim Investigational Site
🇨🇿Rakovnik, Czech Republic
1160.63.42013 Boehringer Ingelheim Investigational Site
🇨🇿Slany, Czech Republic
1160.63.37202 Boehringer Ingelheim Investigational Site
🇪🇪Kohtla-Järve, Estonia
1160.63.37203 Boehringer Ingelheim Investigational Site
🇪🇪Tallin, Estonia
1160.63.42008 Boehringer Ingelheim Investigational Site
🇨🇿Kladno, Czech Republic
1160.63.31006 Boehringer Ingelheim Investigational Site
🇳🇱Breda, Netherlands
1160.63.31011 Boehringer Ingelheim Investigational Site
🇳🇱Den Helder, Netherlands
1160.63.31007 Boehringer Ingelheim Investigational Site
🇳🇱Den Haag, Netherlands
1160.63.31001 Boehringer Ingelheim Investigational Site
🇳🇱Groningen, Netherlands
1160.63.41008 Boehringer Ingelheim Investigational Site
🇨🇭Zug, Switzerland
1160.63.31003 Boehringer Ingelheim Investigational Site
🇳🇱Eindhoven, Netherlands
1160.63.66001 Boehringer Ingelheim Investigational Site
🇹🇭Chiang Mai, Thailand
1160.63.41014 Boehringer Ingelheim Investigational Site
🇨🇭Luzern, Switzerland
1160.63.66002 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand
1160.63.66004 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand
1160.63.39017 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1160.63.01035 Boehringer Ingelheim Investigational Site
🇺🇸Bellevue, Washington, United States
1160.63.01023 Boehringer Ingelheim Investigational Site
🇺🇸Huntsville, Alabama, United States
1160.63.01014 Boehringer Ingelheim Investigational Site
🇺🇸Colorado Springs, Colorado, United States
1160.63.01003 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
1160.63.01022 Boehringer Ingelheim Investigational Site
🇺🇸Lafayette, Louisiana, United States
1160.63.01044 Boehringer Ingelheim Investigational Site
🇺🇸New Iberia, Louisiana, United States
1160.63.01017 Boehringer Ingelheim Investigational Site
🇺🇸Biddeford, Maine, United States
1160.63.01016 Boehringer Ingelheim Investigational Site
🇺🇸Worcester, Massachusetts, United States
1160.63.01037 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
1160.63.01019 Boehringer Ingelheim Investigational Site
🇺🇸Missoula, Montana, United States
1160.63.01001 Boehringer Ingelheim Investigational Site
🇺🇸Uniontown, Pennsylvania, United States
1160.63.01024 Boehringer Ingelheim Investigational Site
🇺🇸Uniontown, Pennsylvania, United States
1160.63.41005 Boehringer Ingelheim Investigational Site
🇨🇭Schiers, Switzerland
1160.63.01030 Boehringer Ingelheim Investigational Site
🇺🇸Key West, Florida, United States
1160.63.61002 Boehringer Ingelheim Investigational Site
🇦🇺Greenslopes, Queensland, Australia
1160.63.61003 Boehringer Ingelheim Investigational Site
🇦🇺Elizabeth Vale, South Australia, Australia
1160.63.61001 Boehringer Ingelheim Investigational Site
🇦🇺Clayton, Victoria, Australia
1160.63.61004 Boehringer Ingelheim Investigational Site
🇦🇺Nedlands, Western Australia, Australia
1160.63.43005 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
1160.63.43001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.63.66003 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand
1160.63.43002 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.63.43004 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1160.63.32005 Boehringer Ingelheim Investigational Site
🇧🇪Aalst, Belgium
1160.63.32004 Boehringer Ingelheim Investigational Site
🇧🇪Duffel, Belgium
1160.63.32003 Boehringer Ingelheim Investigational Site
🇧🇪Kortrijk, Belgium
1160.63.32001 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
1160.63.32002 Boehringer Ingelheim Investigational Site
🇧🇪Lier, Belgium
1160.63.02013 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1160.63.02004 Boehringer Ingelheim Investigational Site
🇨🇦Saint John, New Brunswick, Canada
1160.63.02005 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1160.63.02020 Boehringer Ingelheim Investigational Site
🇨🇦Quebec, Canada
1160.63.42004 Boehringer Ingelheim Investigational Site
🇨🇿Ceske Budejovice, Czech Republic
1160.63.42003 Boehringer Ingelheim Investigational Site
🇨🇿Jablonec nad Nisou, Czech Republic
1160.63.42012 Boehringer Ingelheim Investigational Site
🇨🇿Liberec, Czech Republic
1160.63.42010 Boehringer Ingelheim Investigational Site
🇨🇿Nymburk, Czech Republic
1160.63.42011 Boehringer Ingelheim Investigational Site
🇨🇿Ostrava-Vitkovice, Czech Republic
1160.63.42009 Boehringer Ingelheim Investigational Site
🇨🇿Ostrava, Czech Republic
1160.63.42001 Boehringer Ingelheim Investigational Site
🇨🇿Prague 4, Czech Republic
1160.63.42005 Boehringer Ingelheim Investigational Site
🇨🇿Prostejov, Czech Republic
1160.63.42014 Boehringer Ingelheim Investigational Site
🇨🇿Tabor, Czech Republic
1160.63.49013 Boehringer Ingelheim Investigational Site
🇩🇪Darmstadt, Germany
1160.63.37201 Boehringer Ingelheim Investigational Site
🇪🇪Tartu, Estonia
1160.63.49018 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
1160.63.49011 Boehringer Ingelheim Investigational Site
🇩🇪Ludwigshafen, Germany
1160.63.49014 Boehringer Ingelheim Investigational Site
🇩🇪Gießen, Germany
1160.63.49005 Boehringer Ingelheim Investigational Site
🇩🇪Mannheim, Germany
1160.63.49010 Boehringer Ingelheim Investigational Site
🇩🇪Mannheim, Germany
1160.63.49007 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1160.63.39019 Boehringer Ingelheim Investigational Site
🇮🇹Chieti Scalo (CH), Italy
1160.63.49009 Boehringer Ingelheim Investigational Site
🇩🇪Püttlingen, Germany
1160.63.39006 Boehringer Ingelheim Investigational Site
🇮🇹Bergamo, Italy
1160.63.39015 Boehringer Ingelheim Investigational Site
🇮🇹Castelfranco Veneto (TV), Italy
1160.63.39003 Boehringer Ingelheim Investigational Site
🇮🇹Cosenza, Italy
1160.63.39008 Boehringer Ingelheim Investigational Site
🇮🇹Fidenza (PR), Italy
1160.63.39011 Boehringer Ingelheim Investigational Site
🇮🇹Firenze, Italy
1160.63.39009 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1160.63.39001 Boehringer Ingelheim Investigational Site
🇮🇹Palermo, Italy
1160.63.39020 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1160.63.39022 Boehringer Ingelheim Investigational Site
🇮🇹Napoli, Italy
1160.63.39004 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1160.63.39010 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1160.63.39007 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1160.63.39012 Boehringer Ingelheim Investigational Site
🇮🇹Rimini, Italy
1160.63.39014 Boehringer Ingelheim Investigational Site
🇮🇹Treviso, Italy
1160.63.39016 Boehringer Ingelheim Investigational Site
🇮🇹Vittorio veneto (TV), Italy
1160.63.39002 Boehringer Ingelheim Investigational Site
🇮🇹Udine, Italy
1160.63.82003 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
1160.63.82005 Boehringer Ingelheim Investigational Site
🇰🇷Kyeonggi-do, Korea, Republic of
1160.63.82001 Boehringer Ingelheim Investigational Site
🇰🇷Kyunggi-do, Korea, Republic of
1160.63.82004 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.63.82006 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.63.82008 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.63.82011 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1160.63.82007 Boehringer Ingelheim Investigational Site
🇰🇷Suwon, Korea, Republic of
1160.63.37102 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
1160.63.37001 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
1160.63.31009 Boehringer Ingelheim Investigational Site
🇳🇱Heerlen, Netherlands
1160.63.31008 Boehringer Ingelheim Investigational Site
🇳🇱Oss, Netherlands
1160.63.64002 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch, New Zealand
1160.63.48010 Boehringer Ingelheim Investigational Site
🇵🇱Kielce, Poland
1160.63.48003 Boehringer Ingelheim Investigational Site
🇵🇱Poznan, Poland
1160.63.48001 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.48002 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.48004 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.48005 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.48006 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.48007 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.48008 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1160.63.07005 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1160.63.65001 Boehringer Ingelheim Investigational Site
🇸🇬Singapore, Singapore
1160.63.07006 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1160.63.27003 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1160.63.27009 Boehringer Ingelheim Investigational Site
🇿🇦Krugersdorp, South Africa
1160.63.46001 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.63.27001 Boehringer Ingelheim Investigational Site
🇿🇦Somerset West, South Africa
1160.63.41009 Boehringer Ingelheim Investigational Site
🇨🇭Thun, Switzerland
1160.63.41006 Boehringer Ingelheim Investigational Site
🇨🇭Zurich, Switzerland
1160.63.46006 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1160.63.46004 Boehringer Ingelheim Investigational Site
🇸🇪Mölndal, Sweden
1160.63.46002 Boehringer Ingelheim Investigational Site
🇸🇪Lund, Sweden
1160.63.46007 Boehringer Ingelheim Investigational Site
🇸🇪Skövde, Sweden
1160.63.46005 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1160.63.46003 Boehringer Ingelheim Investigational Site
🇸🇪Värnamo, Sweden
1160.63.41001 Boehringer Ingelheim Investigational Site
🇨🇭Glarus, Switzerland
1160.63.41016 Boehringer Ingelheim Investigational Site
🇨🇭Luzern 16, Switzerland
1160.63.49017 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
1160.63.82010 Boehringer Ingelheim Investigational Site
🇰🇷Gwangju-si, Korea, Republic of
1160.63.27007 Boehringer Ingelheim Investigational Site
🇿🇦Centurion, South Africa
1160.63.01011 Boehringer Ingelheim Investigational Site
🇺🇸Salt Lake City, Utah, United States
1160.63.01025 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1160.63.01005 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
1160.63.01007 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1160.63.01004 Boehringer Ingelheim Investigational Site
🇺🇸Salisbury, Maryland, United States