Venous Thromboembolism Clinical Trial
— RE-SONATEOfficial title:
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
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).
Status | Completed |
Enrollment | 1353 |
Est. completion date | |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study. 2. Written informed consent Exclusion criteria: 1. Younger then 18 years of age 2. Indication for VKA other than DVT and/or PE 3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued 4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN 5. Creatinine clearance < 30 ml/min 6. Acute bacterial endocarditis 7. Active bleeding or high risk for bleeding. 8. Uncontrolled hypertension (investigators judgement) 9. Intake of another experimental drug within the 30 days prior to randomization into the study 10. Life expectancy <6 months 11. Childbearing potential without proper contraceptive measures*, pregnancy or breast feeding |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | 1160.63.61001 Boehringer Ingelheim Investigational Site | Clayton | Victoria |
Australia | 1160.63.61003 Boehringer Ingelheim Investigational Site | Elizabeth Vale | South Australia |
Australia | 1160.63.61002 Boehringer Ingelheim Investigational Site | Greenslopes | Queensland |
Australia | 1160.63.61004 Boehringer Ingelheim Investigational Site | Nedlands | Western Australia |
Austria | 1160.63.43005 Boehringer Ingelheim Investigational Site | Graz | |
Austria | 1160.63.43006 Boehringer Ingelheim Investigational Site | Innsbruck | |
Austria | 1160.63.43001 Boehringer Ingelheim Investigational Site | Wien | |
Austria | 1160.63.43002 Boehringer Ingelheim Investigational Site | Wien | |
Austria | 1160.63.43004 Boehringer Ingelheim Investigational Site | Wien | |
Belgium | 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 | |
Canada | 1160.63.02013 Boehringer Ingelheim Investigational Site | Edmonton | Alberta |
Canada | 1160.63.02005 Boehringer Ingelheim Investigational Site | Hamilton | Ontario |
Canada | 1160.63.02020 Boehringer Ingelheim Investigational Site | Quebec | |
Canada | 1160.63.02004 Boehringer Ingelheim Investigational Site | Saint John | New Brunswick |
Czech Republic | 1160.63.42004 Boehringer Ingelheim Investigational Site | Ceske Budejovice | |
Czech Republic | 1160.63.42003 Boehringer Ingelheim Investigational Site | Jablonec nad Nisou | |
Czech Republic | 1160.63.42008 Boehringer Ingelheim Investigational Site | Kladno | |
Czech Republic | 1160.63.42012 Boehringer Ingelheim Investigational Site | Liberec | |
Czech Republic | 1160.63.42010 Boehringer Ingelheim Investigational Site | Nymburk | |
Czech Republic | 1160.63.42009 Boehringer Ingelheim Investigational Site | Ostrava | |
Czech Republic | 1160.63.42011 Boehringer Ingelheim Investigational Site | Ostrava-Vitkovice | |
Czech Republic | 1160.63.42001 Boehringer Ingelheim Investigational Site | Prague 4 | |
Czech Republic | 1160.63.42002 Boehringer Ingelheim Investigational Site | Prague 4-Krc | |
Czech Republic | 1160.63.42006 Boehringer Ingelheim Investigational Site | Praha 4 | |
Czech Republic | 1160.63.42005 Boehringer Ingelheim Investigational Site | Prostejov | |
Czech Republic | 1160.63.42007 Boehringer Ingelheim Investigational Site | Rakovnik | |
Czech Republic | 1160.63.42013 Boehringer Ingelheim Investigational Site | Slany | |
Czech Republic | 1160.63.42014 Boehringer Ingelheim Investigational Site | Tabor | |
Estonia | 1160.63.37202 Boehringer Ingelheim Investigational Site | Kohtla-Järve | |
Estonia | 1160.63.37203 Boehringer Ingelheim Investigational Site | Tallin | |
Estonia | 1160.63.37201 Boehringer Ingelheim Investigational Site | Tartu | |
Germany | 1160.63.49013 Boehringer Ingelheim Investigational Site | Darmstadt | |
Germany | 1160.63.49017 Boehringer Ingelheim Investigational Site | Dresden | |
Germany | 1160.63.49018 Boehringer Ingelheim Investigational Site | Dresden | |
Germany | 1160.63.49014 Boehringer Ingelheim Investigational Site | Gießen | |
Germany | 1160.63.49011 Boehringer Ingelheim Investigational Site | Ludwigshafen | |
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 | 1160.63.49009 Boehringer Ingelheim Investigational Site | Püttlingen | |
Italy | 1160.63.39006 Boehringer Ingelheim Investigational Site | Bergamo | |
Italy | 1160.63.39015 Boehringer Ingelheim Investigational Site | Castelfranco Veneto (TV) | |
Italy | 1160.63.39019 Boehringer Ingelheim Investigational Site | Chieti Scalo (CH) | |
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 | 1160.63.39004 Boehringer Ingelheim Investigational Site | Milano | |
Italy | 1160.63.39010 Boehringer Ingelheim Investigational Site | Milano | |
Italy | 1160.63.39020 Boehringer Ingelheim Investigational Site | Milano | |
Italy | 1160.63.39022 Boehringer Ingelheim Investigational Site | Napoli | |
Italy | 1160.63.39001 Boehringer Ingelheim Investigational Site | Palermo | |
Italy | 1160.63.39007 Boehringer Ingelheim Investigational Site | Pisa | |
Italy | 1160.63.39012 Boehringer Ingelheim Investigational Site | Rimini | |
Italy | 1160.63.39017 Boehringer Ingelheim Investigational Site | Roma | |
Italy | 1160.63.39014 Boehringer Ingelheim Investigational Site | Treviso | |
Italy | 1160.63.39002 Boehringer Ingelheim Investigational Site | Udine | |
Italy | 1160.63.39016 Boehringer Ingelheim Investigational Site | Vittorio veneto (TV) | |
Korea, Republic of | 1160.63.82010 Boehringer Ingelheim Investigational Site | Gwangju-si | |
Korea, Republic of | 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 | |
Latvia | 1160.63.37101 Boehringer Ingelheim Investigational Site | Daugavpils | |
Latvia | 1160.63.37102 Boehringer Ingelheim Investigational Site | Riga | |
Lithuania | 1160.63.37002 Boehringer Ingelheim Investigational Site | Kaunas | |
Lithuania | 1160.63.37001 Boehringer Ingelheim Investigational Site | Vilnius | |
Netherlands | 1160.63.31010 Boehringer Ingelheim Investigational Site | Assen | |
Netherlands | 1160.63.31006 Boehringer Ingelheim Investigational Site | Breda | |
Netherlands | 1160.63.31007 Boehringer Ingelheim Investigational Site | Den Haag | |
Netherlands | 1160.63.31011 Boehringer Ingelheim Investigational Site | Den Helder | |
Netherlands | 1160.63.31012 Boehringer Ingelheim Investigational Site | Dirksland | |
Netherlands | 1160.63.31003 Boehringer Ingelheim Investigational Site | Eindhoven | |
Netherlands | 1160.63.31001 Boehringer Ingelheim Investigational Site | Groningen | |
Netherlands | 1160.63.31009 Boehringer Ingelheim Investigational Site | Heerlen | |
Netherlands | 1160.63.31008 Boehringer Ingelheim Investigational Site | Oss | |
New Zealand | 1160.63.64002 Boehringer Ingelheim Investigational Site | Christchurch | |
Poland | 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 | |
Russian Federation | 1160.63.07007 Boehringer Ingelheim Investigational Site | Ekaterinburg | |
Russian Federation | 1160.63.07004 Boehringer Ingelheim Investigational Site | Kursk | |
Russian Federation | 1160.63.07014 Boehringer Ingelheim Investigational Site | Ufa | |
Russian Federation | 1160.63.07005 Boehringer Ingelheim Investigational Site | Yaroslavl | |
Russian Federation | 1160.63.07006 Boehringer Ingelheim Investigational Site | Yaroslavl | |
Singapore | 1160.63.65001 Boehringer Ingelheim Investigational Site | Singapore | |
South Africa | 1160.63.27003 Boehringer Ingelheim Investigational Site | Cape Town | |
South Africa | 1160.63.27007 Boehringer Ingelheim Investigational Site | Centurion | |
South Africa | 1160.63.27009 Boehringer Ingelheim Investigational Site | Krugersdorp | |
South Africa | 1160.63.27001 Boehringer Ingelheim Investigational Site | Somerset West | |
Sweden | 1160.63.46001 Boehringer Ingelheim Investigational Site | Göteborg | |
Sweden | 1160.63.46006 Boehringer Ingelheim Investigational Site | Göteborg | |
Sweden | 1160.63.46002 Boehringer Ingelheim Investigational Site | Lund | |
Sweden | 1160.63.46004 Boehringer Ingelheim Investigational Site | Mölndal | |
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 | |
Switzerland | 1160.63.41012 Boehringer Ingelheim Investigational Site | Basel | |
Switzerland | 1160.63.41011 Boehringer Ingelheim Investigational Site | Bruderholz | |
Switzerland | 1160.63.41003 Boehringer Ingelheim Investigational Site | Cham | |
Switzerland | 1160.63.41001 Boehringer Ingelheim Investigational Site | Glarus | |
Switzerland | 1160.63.41014 Boehringer Ingelheim Investigational Site | Luzern | |
Switzerland | 1160.63.41016 Boehringer Ingelheim Investigational Site | Luzern 16 | |
Switzerland | 1160.63.41005 Boehringer Ingelheim Investigational Site | Schiers | |
Switzerland | 1160.63.41009 Boehringer Ingelheim Investigational Site | Thun | |
Switzerland | 1160.63.41022 Boehringer Ingelheim Investigational Site | Wetzikon | |
Switzerland | 1160.63.41008 Boehringer Ingelheim Investigational Site | Zug | |
Switzerland | 1160.63.41006 Boehringer Ingelheim Investigational Site | Zurich | |
Thailand | 1160.63.66002 Boehringer Ingelheim Investigational Site | Bangkok | |
Thailand | 1160.63.66003 Boehringer Ingelheim Investigational Site | Bangkok | |
Thailand | 1160.63.66004 Boehringer Ingelheim Investigational Site | Bangkok | |
Thailand | 1160.63.66001 Boehringer Ingelheim Investigational Site | Chiang Mai | |
United States | 1160.63.01035 Boehringer Ingelheim Investigational Site | Bellevue | Washington |
United States | 1160.63.01017 Boehringer Ingelheim Investigational Site | Biddeford | Maine |
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 | 1160.63.01014 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado |
United States | 1160.63.01032 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
United States | 1160.63.01023 Boehringer Ingelheim Investigational Site | Huntsville | Alabama |
United States | 1160.63.01003 Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
United States | 1160.63.01030 Boehringer Ingelheim Investigational Site | Key West | Florida |
United States | 1160.63.01022 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana |
United States | 1160.63.01002 Boehringer Ingelheim Investigational Site | Laguna Hills | California |
United States | 1160.63.01019 Boehringer Ingelheim Investigational Site | Missoula | Montana |
United States | 1160.63.01044 Boehringer Ingelheim Investigational Site | New Iberia | Louisiana |
United States | 1160.63.01007 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
United States | 1160.63.01004 Boehringer Ingelheim Investigational Site | Salisbury | Maryland |
United States | 1160.63.01011 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah |
United States | 1160.63.01020 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina |
United States | 1160.63.01037 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
United States | 1160.63.01001 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania |
United States | 1160.63.01024 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania |
United States | 1160.63.01016 Boehringer Ingelheim Investigational Site | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Australia, Austria, Belgium, Canada, Czech Republic, Estonia, Germany, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Sweden, Switzerland, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period | 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. | 6 months | No |
Secondary | Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period | 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. | 6 months | No |
Secondary | Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period | Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described. | 6 months | No |
Secondary | Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period | Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described. | 6 months | No |
Secondary | Centrally Confirmed Unexplained Deaths During the Intended Treatment Period | Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described. | 6 months | No |
Secondary | Centrally Confirmed Bleeding Event During the Treatment Period | 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. |
6 months | Yes |
Secondary | Centrally Confirmed Cardiovascular Events During the Treatment Period | Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups. | 6 months | No |
Secondary | Laboratory Measures, Especially Liver Function Tests (LFTs) | Number of participants with possible clinically significant abnormalities during the treatment period. | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05347550 -
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
|
N/A | |
Enrolling by invitation |
NCT05794165 -
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
|
Phase 2 | |
Completed |
NCT02379806 -
The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
|
Phase 3 | |
Recruiting |
NCT03691753 -
Safety and Efficacy Study of Fitaya Vena Cava Filter
|
N/A | |
Completed |
NCT02197416 -
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
|
Phase 3 | |
Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
Completed |
NCT01895777 -
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
|
Phase 3 | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Completed |
NCT04735523 -
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT04736420 -
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT04736719 -
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
Completed |
NCT02829957 -
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
|
Phase 2/Phase 3 | |
Completed |
NCT02912234 -
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
|
Phase 1 | |
Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT02223260 -
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
|
Phase 2 | |
Completed |
NCT02661568 -
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
|
N/A | |
Completed |
NCT01972243 -
Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model
|
||
Completed |
NCT01431456 -
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
|
Phase 3 |