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NCT00558259 Clinical Trial

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

Venous Thromboembolism Clinical Trial

— RE-SONATE  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00558259
Other study ID # 1160.63
Secondary ID 2007-002586-12
Status Completed
Phase Phase 3
First received November 13, 2007
Last updated June 17, 2014
Start date November 2007

Study information
Verified date February 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Dept of Health and Ageing Therapeutic Goods AdminAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Estonia: State Agency of Medicines, EE-5041TartuGermany: BfArM-Federal Authorities for Drugs and Medical DevicesItaly: Comitato di Bioetica dell'Azienda Ospedaliero-Universitaria Policlinico "Giaccone" di PalermoKorea, Republic of: Korea Drug and Food AdministrationLatvia: State Agency of Medicines, LV-1003 RigaLithuania: State Medicines Control Agency, LT-01132 VilniusNetherlands: Central Committee on Research Involving Human Subjects (CCMO)New Zealand: Multicentre Ethics Committee/MedsafePoland: Registration Medicinal Product Medical Device Biocidal ProductRussia: Pharmacological Committee, Ministry of HealthSingapore: Health Sciences Authority,Ministry of HealthSouth Africa: Medicines Control CouncilSweden: Medical Products Agency Regional Ethics Committee of GothenburgSwitzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic ProductsThailand: Ministry of Public HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• dabigatran etexilate 150 mg twice daily (BID)
dabigatran etexilate capsules 150 mg BID
• matching placebo twice daily (BID)
Matching placebo BID

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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, 

Outcome
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
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