Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

Thromboembolism Clinical Trial

— RE-COVER I  

Official title:

A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291330
• Other study ID #: 1160.53
• Secondary ID: 2005-001999-12
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2006
• Last updated: June 3, 2014
• Start date: February 2006

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology)Australia: Responsilble Ethics CommitteeAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: National Health Surveillance AgencyCanada: Health Canada, Therapeutic Products DirectorateCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Denmark: The Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAGreece: National Organization for Medicines (EOF) National Ethics CommitteeHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Drug Control General of IndiaIsrael: Clinical trials unit, pharmaceutical division, ministry of health 29 Rivka street JerusalemItaly: Comitato Etico Aziende Sanitarie Umbria - ELLERA DI CORCIANO (PG)Mexico: Federal Commission for Protection Against Health RisksNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)New Zealand: Multicentre Ethics Committee/MedsafeNorway: Norwegian Medicines Agency (Statens Legemiddelverk)Portugal: INFARMED, National Authority of Medicines and Health Products, IPRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26South Africa: Medicines Control CouncilSpain: Spanish Agency for Medicines and Health ProductsSweden: The National Board of Health and WelfareTurkey: Ministry of Health Central Ethics CommitteeUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2564
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate

2. Male or female, being 18 years of age or older

3. Written informed consent for study participation

Exclusion criteria

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment

2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs

3. Actual or anticipated use of vena cava filter

4. Contraindications to anticoagulant therapy

5. Patients who in the investigators opinion should not be treated with warfarin

6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications

7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding

8. Known anaemia

9. Need of anticoagulant treatment for disorders other than VTE

10. Recent unstable cardiovascular disease

11. Elevated AST or ALT > 2x ULN

12. Liver disease expected to have any potential impact on survival

13. Patients who have developed transaminase elevations upon exposure to ximelagatran

14. Severe renal impairment

15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception

16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study

17. Patients considered unsuitable for inclusion by the investigator

Study Design

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• dabigatran etexilate 150 mg
twice daily
• warfarin (INR 2-3)
prn to maintain INR (2-3)

Locations

Country	Name	City	State
Argentina	1160.53.54017 Boehringer Ingelheim Investigational Site	Adrogué
Argentina	1160.53.54003 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1160.53.54005 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1160.53.54006 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1160.53.54007 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1160.53.54010 Boehringer Ingelheim Investigational Site	Capital Federal
Australia	1160.53.61004 Boehringer Ingelheim Investigational Site	Bedford Park	South Australia
Australia	1160.53.61003 Boehringer Ingelheim Investigational Site	Box Hill	Victoria
Australia	1160.53.61001 Boehringer Ingelheim Investigational Site	Clayton	Victoria
Australia	1160.53.61005 Boehringer Ingelheim Investigational Site	Perth	Western Australia
Australia	1160.53.61006 The Avenue Cardiovascular Centre	Windsor	Victoria
Australia	1160.53.61002 Boehringer Ingelheim Investigational Site	Woolloongabba	Queensland
Austria	1160.53.43001 Boehringer Ingelheim Investigational Site	Graz
Austria	1160.53.43003 Boehringer Ingelheim Investigational Site	Innsbruck
Austria	1160.53.43002 Boehringer Ingelheim Investigational Site	Wien
Belgium	1160.53.32003 Boehringer Ingelheim Investigational Site	Brussel
Belgium	1160.53.32001 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1160.53.32002 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1160.53.32007 Boehringer Ingelheim Investigational Site	Edegem
Belgium	1160.53.32005 Boehringer Ingelheim Investigational Site	Leuven
Belgium	1160.53.32004 Boehringer Ingelheim Investigational Site	Liège
Brazil	1160.53.55010 Boehringer Ingelheim Investigational Site	Brasília
Brazil	1160.53.55007 Boehringer Ingelheim Investigational Site	Campinas
Brazil	1160.53.55001 Boehringer Ingelheim Investigational Site	Cerqueira César - Sao Paulo
Brazil	1160.53.55002 Boehringer Ingelheim Investigational Site	Cerqueira César - São Paulo
Brazil	1160.53.55014 Boehringer Ingelheim Investigational Site	Cristo Rei - Curitiba
Brazil	1160.53.55011 Boehringer Ingelheim Investigational Site	Goiânia -
Brazil	1160.53.55017 Boehringer Ingelheim Investigational Site	Paraná -
Brazil	1160.53.55012 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1160.53.55016 Boehringer Ingelheim Investigational Site	Rio de Janeiro - RJ
Brazil	1160.53.55004 Boehringer Ingelheim Investigational Site	Santo André
Brazil	1160.53.55005 Boehringer Ingelheim Investigational Site	São José do Rio Preto
Canada	1160.53.02006 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1160.53.02013 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1160.53.02001 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	1160.53.02002 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1160.53.02005 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1160.53.02010 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1160.53.02022 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1160.53.02011 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1160.53.02008 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1160.53.02009 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1160.53.02014 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1160.53.02017 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1160.53.02015 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1160.53.02020 Boehringer Ingelheim Investigational Site	Quebec
Canada	1160.53.02004 Boehringer Ingelheim Investigational Site	Saint Johns	New Brunswick
Canada	1160.53.02003 Boehringer Ingelheim Investigational Site	Sainte-Foy	Quebec
Canada	1160.53.02019 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1160.53.02021 Boehringer Ingelheim Investigational Site	Victoria	British Columbia
Czech Republic	1160.53.42001 Boehringer Ingelheim Investigational Site	Brno
Czech Republic	1160.53.42002 Boehringer Ingelheim Investigational Site	Hradec Kralove
Czech Republic	1160.53.42011 Boehringer Ingelheim Investigational Site	Hranice
Czech Republic	1160.53.42009 Boehringer Ingelheim Investigational Site	Jihlava
Czech Republic	1160.53.42012 Boehringer Ingelheim Investigational Site	Liberec
Czech Republic	1160.53.42015 Boehringer Ingelheim Investigational Site	Novy Jicin
Czech Republic	1160.53.42005 Boehringer Ingelheim Investigational Site	Ostrava-Vitkovice
Czech Republic	1160.53.42004 Boehringer Ingelheim Investigational Site	Praha 2
Czech Republic	1160.53.42014 Boehringer Ingelheim Investigational Site	Tabor
Czech Republic	1160.53.42016 Boehringer Ingelheim Investigational Site	Teplice
Czech Republic	1160.53.42010 Boehringer Ingelheim Investigational Site	Usti nad Labem
Czech Republic	1160.53.42007 Boehringer Ingelheim Investigational Site	Zlin
Denmark	1160.53.45008 Boehringer Ingelheim Investigational Site	Esbjerg
Denmark	1160.53.45009 Boehringer Ingelheim Investigational Site	Holbæk
Denmark	1160.53.45004 Boehringer Ingelheim Investigational Site	København NV
Denmark	1160.53.45007 Boehringer Ingelheim Investigational Site	København S
Denmark	1160.53.45002 Boehringer Ingelheim Investigational Site	Kolding
Denmark	1160.53.45006 Boehringer Ingelheim Investigational Site	Slagelse
France	1160.53.3301A Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301B Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301C Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301D Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301E Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301F Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301H Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3301I Boehringer Ingelheim Investigational Site	Brest Cedex
France	1160.53.3302A Boehringer Ingelheim Investigational Site	Lorient
France	1160.53.3310A Boehringer Ingelheim Investigational Site	Montpellier Cedex 5
France	1160.53.3310B Boehringer Ingelheim Investigational Site	Montpellier Cedex 5
France	1160.53.3310C Boehringer Ingelheim Investigational Site	Montpellier Cedex 5
France	1160.53.3308B Boehringer Ingelheim Investigational Site	Nancy
France	1160.53.3303B Boehringer Ingelheim Investigational Site	St Etienne Cedex 2
France	1160.53.3303C Boehringer Ingelheim Investigational Site	St Etienne Cedex 2
France	1160.53.3303D Boehringer Ingelheim Investigational Site	St Etienne Cedex 2
France	1160.53.3303E Boehringer Ingelheim Investigational Site	St Etienne Cedex 2
France	1160.53.3303A Boehringer Ingelheim Investigational Site	St Priest en Jarez
France	1160.53.3311A Boehringer Ingelheim Investigational Site	Toulon Naval
France	1160.53.3311B Boehringer Ingelheim Investigational Site	Toulon Naval
France	1160.53.3311C Boehringer Ingelheim Investigational Site	Toulon Naval
France	1160.53.3311D Boehringer Ingelheim Investigational Site	Toulon Naval
France	1160.53.3311E Boehringer Ingelheim Investigational Site	Toulon Naval
France	1160.53.3308A Boehringer Ingelheim Investigational Site	Vandoeuvre les Nancy
Germany	1160.53.49017 Boehringer Ingelheim Investigational Site	Dresden
Germany	1160.53.49018 Boehringer Ingelheim Investigational Site	Dresden
Germany	1160.53.49003 Boehringer Ingelheim Investigational Site	Köln
Germany	1160.53.49005 Boehringer Ingelheim Investigational Site	Mannheim
Germany	1160.53.49007 Boehringer Ingelheim Investigational Site	München
Germany	1160.53.49009 Boehringer Ingelheim Investigational Site	Püttlingen
Greece	1160.53.30001 Boehringer Ingelheim Investigational Site	Athens
Greece	1160.53.30005 Boehringer Ingelheim Investigational Site	Athens
Greece	1160.53.30006 Boehringer Ingelheim Investigational Site	Athens
Hungary	1160.53.36001 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1160.53.36006 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1160.53.36002 Boehringer Ingelheim Investigational Site	Debrecen
Hungary	1160.53.36013 Boehringer Ingelheim Investigational Site	Eger
Hungary	1160.53.36012 Boehringer Ingelheim Investigational Site	Gyula
Hungary	1160.53.36004 Boehringer Ingelheim Investigational Site	Miskolc
Hungary	1160.53.36003 Boehringer Ingelheim Investigational Site	Pecs
Hungary	1160.53.36010 Boehringer Ingelheim Investigational Site	Székesfehérvár
Hungary	1160.53.36011 Boehringer Ingelheim Investigational Site	Szombathely
India	1160.53.91011 Boehringer Ingelheim Investigational Site	Bangalore
India	1160.53.91012 Boehringer Ingelheim Investigational Site	Chennai
India	1160.53.91019 Boehringer Ingelheim Investigational Site	Chennai
India	1160.53.91013 Boehringer Ingelheim Investigational Site	Indore
India	1160.53.91021 Boehringer Ingelheim Investigational Site	Karna
India	1160.53.91022 Boehringer Ingelheim Investigational Site	Kerala
India	1160.53.91020 Boehringer Ingelheim Investigational Site	Ludhiana
India	1160.53.91007 Boehringer Ingelheim Investigational Site	Mysore
India	1160.53.91015 Boehringer Ingelheim Investigational Site	Nagpur
India	1160.53.91010 Boehringer Ingelheim Investigational Site	New Delhi
India	1160.53.91005 Boehringer Ingelheim Investigational Site	Pune
India	1160.53.91008 Boehringer Ingelheim Investigational Site	Pune
India	1160.53.91004 Boehringer Ingelheim Investigational Site	Vadodara
Israel	1160.53.97202 Boehringer Ingelheim Investigational Site	Afula
Israel	1160.53.97207 Boehringer Ingelheim Investigational Site	Ashkelon
Israel	1160.53.97211 Boehringer Ingelheim Investigational Site	Haifa
Israel	1160.53.97203 Boehringer Ingelheim Investigational Site	Holon
Israel	1160.53.97205 Boehringer Ingelheim Investigational Site	KfarSaba
Israel	1160.53.97206 Boehringer Ingelheim Investigational Site	Petah Tiqwa
Israel	1160.53.97204 Boehringer Ingelheim Investigational Site	Tel Hashomer
Israel	1160.53.97210 Boehringer Ingelheim Investigational Site	Tel-Aviv
Israel	1160.53.97201 Boehringer Ingelheim Investigational Site	Zerifin
Italy	1160.53.39003 Boehringer Ingelheim Investigational Site	Bologna
Italy	1160.53.39002 Boehringer Ingelheim Investigational Site	Padova
Italy	1160.53.39001 Boehringer Ingelheim Investigational Site	Perugia
Italy	1160.53.39004 Boehringer Ingelheim Investigational Site	Reggio Emilia
Italy	1160.53.39007 Boehringer Ingelheim Investigational Site	Vimercate
Italy	1160.53.39005 Boehringer Ingelheim Investigational Site	Vittorio Veneto (tv)
Mexico	1160.53.5264 Boehringer Ingelheim Investigational Site	Chihuahua
Mexico	1160.53.5270 Boehringer Ingelheim Investigational Site	Culiacan
Mexico	1160.53.5262 Boehringer Ingelheim Investigational Site	San Luis Potosí
Netherlands	1160.53.31010 Boehringer Ingelheim Investigational Site	's Hertogenbosch
Netherlands	1160.53.31001 Boehringer Ingelheim Investigational Site	Amersfoort
Netherlands	1160.53.31006 Boehringer Ingelheim Investigational Site	Amsterdam
Netherlands	1160.53.31013 Boehringer Ingelheim Investigational Site	Eindhoven
Netherlands	1160.53.31005 Boehringer Ingelheim Investigational Site	Maastricht
Netherlands	1160.53.31002 Boehringer Ingelheim Investigational Site	Nieuwegein
Netherlands	1160.53.31004 Boehringer Ingelheim Investigational Site	Rotterdam
Netherlands	1160.53.31009 Boehringer Ingelheim Investigational Site	Rotterdam
New Zealand	1160.53.64003 Boehringer Ingelheim Investigational Site	Auckland
New Zealand	1160.53.64004 Boehringer Ingelheim Investigational Site	Christchurch
New Zealand	1160.53.64002 Boehringer Ingelheim Investigational Site	Otahuhu Auckland
New Zealand	1160.53.64001 Boehringer Ingelheim Investigational Site	Takapuna Auckland
Norway	1160.53.47001 Boehringer Ingelheim Investigational Site	Oslo
Norway	1160.53.47004 Boehringer Ingelheim Investigational Site	Oslo
Norway	1160.53.47003 Boehringer Ingelheim Investigational Site	Rud
Norway	1160.53.47005 Boehringer Ingelheim Investigational Site	Trondheim
Portugal	1160.53.35104 Boehringer Ingelheim Investigational Site	Almada
Portugal	1160.53.35109 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	1160.53.35101 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1160.53.35102 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1160.53.35105 Boehringer Ingelheim Investigational Site	Lisboa
Russian Federation	1160.53.07011 Boehringer Ingelheim Investigational Site	Chelyabinsk
Russian Federation	1160.53.07021 Boehringer Ingelheim Investigational Site	Chelyabinsk
Russian Federation	1160.53.07007 Boehringer Ingelheim Investigational Site	Ekaterinburg
Russian Federation	1160.53.07016 Boehringer Ingelheim Investigational Site	Krasnodar
Russian Federation	1160.53.07004 Boehringer Ingelheim Investigational Site	Kursk
Russian Federation	1160.53.07003 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1160.53.07010 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1160.53.07020 Boehringer Ingelheim Investigational Site	Omsk
Russian Federation	1160.53.07018 Boehringer Ingelheim Investigational Site	Pskov
Russian Federation	1160.53.07009 Boehringer Ingelheim Investigational Site	Rostov-na-Donu
Russian Federation	1160.53.07023 Boehringer Ingelheim Investigational Site	Rostov-na-Donu
Russian Federation	1160.53.07024 Boehringer Ingelheim Investigational Site	Rostov-na-Donu
Russian Federation	1160.53.07025 Boehringer Ingelheim Investigational Site	Rostov-na-Donu
Russian Federation	1160.53.07001 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1160.53.07014 Boehringer Ingelheim Investigational Site	Ufa
Russian Federation	1160.53.07005 Boehringer Ingelheim Investigational Site	Yaroslavl
Russian Federation	1160.53.07006 Boehringer Ingelheim Investigational Site	Yaroslavl
Slovakia	1160.53.42107 Boehringer Ingelheim Investigational Site	Banska Bystrica
Slovakia	1160.53.42106 Boehringer Ingelheim Investigational Site	Lucenec
Slovakia	1160.53.42102 Boehringer Ingelheim Investigational Site	Nitra
Slovakia	1160.53.42103 Boehringer Ingelheim Investigational Site	Nove Zamky
Slovakia	1160.53.42104 Boehringer Ingelheim Investigational Site	Zilina
South Africa	1160.53.27007 Boehringer Ingelheim Investigational Site	Centurion
South Africa	1160.53.27001 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1160.53.27002 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1160.53.27004 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1160.53.27006 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1160.53.27009 Suite 404, Medical Centre	Pretoria
South Africa	1160.53.27003 Boehringer Ingelheim Investigational Site	Randburg
South Africa	1160.53.27008 Suite M5, Second Floor	Richards Bay
South Africa	1160.53.27005 Boehringer Ingelheim Investigational Site	Roodepoort
Spain	1160.53.34012 Boehringer Ingelheim Investigational Site	Badalona (Barcelona)
Spain	1160.53.34001 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1160.53.34002 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1160.53.34007 Boehringer Ingelheim Investigational Site	Cartagena. Murcia
Spain	1160.53.34003 Boehringer Ingelheim Investigational Site	Cuenca
Spain	1160.53.34009 Boehringer Ingelheim Investigational Site	Madrid
Spain	1160.53.34010 Boehringer Ingelheim Investigational Site	Madrid
Spain	1160.53.34004 Boehringer Ingelheim Investigational Site	Santander
Spain	1160.53.34005 Boehringer Ingelheim Investigational Site	Torrelavega.Santander
Spain	1160.53.34011 Boehringer Ingelheim Investigational Site	Valencia
Sweden	1160.53.46002 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	1160.53.46006 Boehringer Ingelheim Investigational Site	Jönköping
Sweden	1160.53.46001 Boehringer Ingelheim Investigational Site	Stockholm
Sweden	1160.53.46007 Boehringer Ingelheim Investigational Site	Stockholm
Sweden	1160.53.46008 Boehringer Ingelheim Investigational Site	Stockholm
Sweden	1160.53.46005 Boehringer Ingelheim Investigational Site	Sundsvall
Sweden	1160.53.46003 Boehringer Ingelheim Investigational Site	Uppsala
Turkey	1160.53.90003 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1160.53.90004 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1160.53.90005 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1160.53.90001 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1160.53.90002 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1160.53.90007 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1160.53.90006 Boehringer Ingelheim Investigational Site	Izmir
Ukraine	1160.53.38006 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1160.53.38005 Boehringer Ingelheim Investigational Site	Vinnitsa
Ukraine	1160.53.38003 Boehringer Ingelheim Investigational Site	Zaporozhye
United Kingdom	1160.53.44008 Boehringer Ingelheim Investigational Site	Aberdeen
United Kingdom	1160.53.44005 Boehringer Ingelheim Investigational Site	Headington, Oxford
United Kingdom	1160.53.44004 Boehringer Ingelheim Investigational Site	London
United Kingdom	1160.53.44009 Boehringer Ingelheim Investigational Site	London
United Kingdom	1160.53.44011 Boehringer Ingelheim Investigational Site	London
United Kingdom	1160.53.44006 Boehringer Ingelheim Investigational Site	Newcastle upon Tyne
United Kingdom	1160.53.44012 Boehringer Ingelheim Investigational Site	Sheffield
United States	1160.53.01036 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1160.53.01052 Boehringer Ingelheim Investigational Site	Altoona	Pennsylvania
United States	1160.53.01019 Boehringer Ingelheim Investigational Site	Augusta	Georgia
United States	1160.53.01014 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	1160.53.01027 Boehringer Ingelheim Investigational Site	Chapel Hill	North Carolina
United States	1160.53.01044 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1160.53.01008 Boehringer Ingelheim Investigational Site	Decatur	Georgia
United States	1160.53.01023 Boehringer Ingelheim Investigational Site	Detroit	Michigan
United States	1160.53.01030 Boehringer Ingelheim Investigational Site	Grand Forks	North Dakota
United States	1160.53.01056 Boehringer Ingelheim Investigational Site	Hartford	Connecticut
United States	1160.53.01031 Boehringer Ingelheim Investigational Site	Lebanon	New Hampshire
United States	1160.53.01010 Boehringer Ingelheim Investigational Site	Marietta	Georgia
United States	1160.53.01035 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	1160.53.01029 Boehringer Ingelheim Investigational Site	Pontiac	Michigan
United States	1160.53.01028 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	1160.53.01017 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	1160.53.01033 Boehringer Ingelheim Investigational Site	Sarasota	Florida
United States	1160.53.01046 Boehringer Ingelheim Investigational Site	Sarasota	Florida
United States	1160.53.01009 Boehringer Ingelheim Investigational Site	St. Louis Park	Minnesota
United States	1160.53.01055 Boehringer Ingelheim Investigational Site	Summerville	South Carolina
United States	1160.53.01013 Boehringer Ingelheim Investigational Site	Toledo	Ohio
United States	1160.53.01025 Boehringer Ingelheim Investigational Site	Valhalla	New York
United States	1160.53.01039 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Mexico,  Netherlands,  New Zealand,  Norway,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE	All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)	No
Secondary	Number of Participants With Recurrent Symptomatic VTE and All Deaths	VTE or any death which occured from randomisation to end of post treatment period.; All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.	No
Secondary	Number of Participants With Recurrent Symptomatic DVT	Symptomatic DVT which occured from randomisation to end of post treatment period.; All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.	No
Secondary	Number of Participants With Recurrent Symptomatic Non-fatal PE	Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.; All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.	No
Secondary	Number of Participants Who Died Due to VTE	VTE - related deaths which occured from randomisation to end of post treatment period.; All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.	No
Secondary	Number of Participants Who Died (Any Cause)	Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.	No
Secondary	Number of Participants With Bleeding Events	Major bleeding events (MBE) were defined as; Fatal bleeding; Symptomatic bleeding in a critical area or organ; Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically-relevant bleeding events (CRBE) was defined as; spontaneous skin hematoma >=25 cm²; spontaneous nose bleed >5 min; macroscopic hematuria spontaneous or >24 hours if associated with an intervention; spontaneous rectal bleeding (more than spotting on toilet paper); gingival bleeding >5 min; leading to hospitalisation and / or requiring surgical treatment; leading to a transfusion of <2 units of whole blood or red cells; any other bleeding event considered clinically relevant by the investigator; Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.	From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)	Yes
Secondary	Number of Participants With Acute Coronary Syndrome (ACS)	Any ACS occurring during the conduct of the study (centrally adjudicated as definite).; Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.; All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	From first intake of study drug to end of study conduct	No
Secondary	Laboratory Analyses	Frequency of patients with possible clinically significant abnormalities.	From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)	No

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