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NCT00680186 Clinical Trial

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

Thromboembolism Clinical Trial

— RE-COVER II  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00680186
Other study ID # 1160.46
Secondary ID 2007-002631-86
Status Completed
Phase Phase 3
First received May 16, 2008
Last updated May 8, 2014
Start date April 2008

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Dept of Health and Ageing Therapeutic Goods AdminBrazil: National Health Surveillance AgencyBulgaria: Bulgarian Drug Agency, BG-1504 SofiaCanada: Health Canada, Therapeutic Products DirectorateChina: Food and Drug AdministrationCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Denmark: Danish Medicines AgencyFrance: AFSSAPSGreat Britain: MHRAHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Drugs Controller General of IndiaIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteeKorea, Republic of: Korea Drug and Food AdministrationMalaysia: National Pharmaceutical Control BureauNetherlands: Central Committee Research Involving Human SubjectsNew Zealand: Multicentre Ethics Committee/MedsafeNorway: Norwegian Medicines Agency (Statens Legemiddelverk)Philippines: Department of HealthPoland: Registration Medicinal Product Medical Device Biocidal ProductRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSingapore: Health Sciences Authority,Ministry of HealthSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26South Africa: MCC (Medicines Control Council)Spain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyTaiwan: Department of HealthThailand: Ministry of Public HealthTurkey: 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 general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Recruitment information / eligibility
Status Completed
Enrollment 2589
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)

- Male or female, being 18 years of age or older

- Written informed consent for study participation

Exclusion criteria:

- Persistent symptoms of VTE

- PE requiring urgent intervention

- Use of vena cava filter

- Contraindications to anticoagulant therapy

- Allergy to study medications

- Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival

- Severe renal impairment

- Patients considered unsuitable for inclusion

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Warfarin
PRN (to maintain a target INR of 2.0-3.0)
• Dabigatran etexilate
150mg bid

Locations
Country Name City State
Australia 1160.46.61003 Boehringer Ingelheim Investigational Site Box Hill Victoria
Australia 1160.46.61001 Boehringer Ingelheim Investigational Site Clayton Victoria
Australia 1160.46.61007 Boehringer Ingelheim Investigational Site Concord New South Wales
Australia 1160.46.61005 Boehringer Ingelheim Investigational Site Perth Western Australia
Australia 1160.46.61006 Boehringer Ingelheim Investigational Site Windsor Victoria
Brazil 1160.46.55010 Boehringer Ingelheim Investigational Site Brasília
Brazil 1160.46.55007 Boehringer Ingelheim Investigational Site Campinas
Brazil 1160.46.55014 Boehringer Ingelheim Investigational Site Curitiba
Brazil 1160.46.55017 Boehringer Ingelheim Investigational Site Curitiba
Brazil 1160.46.55019 Boehringer Ingelheim Investigational Site Porto Alegre
Brazil 1160.46.55021 Boehringer Ingelheim Investigational Site Recife
Brazil 1160.46.55016 Boehringer Ingelheim Investigational Site Rio de Janeiro - RJ
Brazil 1160.46.55018 Boehringer Ingelheim Investigational Site São Bernardo do Campo
Brazil 1160.46.55020 Boehringer Ingelheim Investigational Site São Paulo
Bulgaria 1160.46.35901 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.46.35903 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.46.35906 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1160.46.35905 Boehringer Ingelheim Investigational Site Varna
Canada 1160.46.02006 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1160.46.02013 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1160.46.02001 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1160.46.02002 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.46.02005 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.46.02010 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1160.46.02008 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.46.02009 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.46.02014 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.46.02017 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1160.46.02015 Boehringer Ingelheim Investigational Site Ottawa Ontario
Canada 1160.46.02020 Boehringer Ingelheim Investigational Site Quebec
Canada 1160.46.02004 Boehringer Ingelheim Investigational Site Saint John New Brunswick
Canada 1160.46.02019 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1160.46.02021 Boehringer Ingelheim Investigational Site Victoria British Columbia
China 1160.46.86001 Boehringer Ingelheim Investigational Site Beijing
China 1160.46.86002 Boehringer Ingelheim Investigational Site Beijing
China 1160.46.86019 Boehringer Ingelheim Investigational Site Beijing
China 1160.46.86014 Boehringer Ingelheim Investigational Site Guangzhou
China 1160.46.86015 Boehringer Ingelheim Investigational Site Guangzhou
China 1160.46.86016 Boehringer Ingelheim Investigational Site Hangzhou
China 1160.46.86003 Boehringer Ingelheim Investigational Site Shanghai
China 1160.46.86004 Boehringer Ingelheim Investigational Site Shanghai
China 1160.46.86005 Boehringer Ingelheim Investigational Site Shanghai
China 1160.46.86011 Boehringer Ingelheim Investigational Site Shanghai
China 1160.46.86007 Boehringer Ingelheim Investigational Site Shenyang
China 1160.46.86017 Boehringer Ingelheim Investigational Site Shijiazhuang
China 1160.46.86018 Boehringer Ingelheim Investigational Site Shijiazhuang
China 1160.46.86021 Boehringer Ingelheim Investigational Site Taiyuan
China 1160.46.86006 Boehringer Ingelheim Investigational Site Tianjin
China 1160.46.86020 Boehringer Ingelheim Investigational Site Yinchuan
Czech Republic 1160.46.42001 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1160.46.42002 Boehringer Ingelheim Investigational Site Hradec Kralove
Czech Republic 1160.46.42012 Boehringer Ingelheim Investigational Site Liberec
Czech Republic 1160.46.42018 Boehringer Ingelheim Investigational Site Litomerice
Czech Republic 1160.46.42015 Boehringer Ingelheim Investigational Site Novy Jicin
Czech Republic 1160.46.42005 Boehringer Ingelheim Investigational Site Ostrava-Vitkovice
Czech Republic 1160.46.42017 Boehringer Ingelheim Investigational Site Prague 4
Czech Republic 1160.46.42014 Boehringer Ingelheim Investigational Site Tabor
Czech Republic 1160.46.42016 Boehringer Ingelheim Investigational Site Teplice
Czech Republic 1160.46.42010 Boehringer Ingelheim Investigational Site Usti nad Labem
Czech Republic 1160.46.42007 Boehringer Ingelheim Investigational Site Zlin
Denmark 1160.46.45001 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1160.46.45008 Boehringer Ingelheim Investigational Site Esbjerg
Denmark 1160.46.45009 Boehringer Ingelheim Investigational Site Holbæk
Denmark 1160.46.45004 Boehringer Ingelheim Investigational Site København NV
France 1160.46.3301A Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.46.3301B Boehringer Ingelheim Investigational Site Brest Cedex
France 1160.46.3315A Boehringer Ingelheim Investigational Site La Roche-Sur-Yon cedex 09
France 1160.46.3315B Boehringer Ingelheim Investigational Site La Roche-Sur-Yon cedex 09
France 1160.46.3313A Boehringer Ingelheim Investigational Site Nantes
France 1160.46.3316A Boehringer Ingelheim Investigational Site Pessac
France 1160.46.3316B Boehringer Ingelheim Investigational Site Pessac
France 1160.46.3303C Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.46.3303D Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.46.3303E Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.46.3303F Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.46.3303G Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.46.3303H Boehringer Ingelheim Investigational Site St Etienne Cedex 2
France 1160.46.3303A Boehringer Ingelheim Investigational Site St Priest En Jarez Cedex
France 1160.46.3303B Boehringer Ingelheim Investigational Site St Priest En Jarez Cedex
Hungary 1160.46.36002 Boehringer Ingelheim Investigational Site Debrecen
Hungary 1160.46.36010 Boehringer Ingelheim Investigational Site Szekesfehervar
Hungary 1160.46.36011 Boehringer Ingelheim Investigational Site Szombathely
India 1160.46.91006 Boehringer Ingelheim Investigational Site Bangalore
India 1160.46.91010 Boehringer Ingelheim Investigational Site Bangalore
India 1160.46.91002 Boehringer Ingelheim Investigational Site Chennai
India 1160.46.91007 Boehringer Ingelheim Investigational Site Chennai
India 1160.46.91012 Boehringer Ingelheim Investigational Site Kolkata
India 1160.46.91009 Boehringer Ingelheim Investigational Site Ludhiana
India 1160.46.91008 Boehringer Ingelheim Investigational Site Nagpur
India 1160.46.91005 Boehringer Ingelheim Investigational Site New Delhi
India 1160.46.91014 Boehringer Ingelheim Investigational Site New Delhi
India 1160.46.91001 Boehringer Ingelheim Investigational Site Pune
India 1160.46.91004 Boehringer Ingelheim Investigational Site Pune
India 1160.46.91011 Boehringer Ingelheim Investigational Site Tamil Nadu
India 1160.46.91013 Boehringer Ingelheim Investigational Site Vadodara
India 1160.46.91003 Boehringer Ingelheim Investigational Site Vadodra
Israel 1160.46.97202 Boehringer Ingelheim Investigational Site Afula
Israel 1160.46.97207 Boehringer Ingelheim Investigational Site Ashkelon
Israel 1160.46.97212 Boehringer Ingelheim Investigational Site DN Lower Galillee
Israel 1160.46.97211 Boehringer Ingelheim Investigational Site Haifa
Israel 1160.46.97203 Boehringer Ingelheim Investigational Site Holon
Israel 1160.46.97205 Boehringer Ingelheim Investigational Site KfarSaba
Israel 1160.46.97209 Boehringer Ingelheim Investigational Site Nazareth
Israel 1160.46.97206 Boehringer Ingelheim Investigational Site Petah Tiqwa
Israel 1160.46.97210 Boehringer Ingelheim Investigational Site Tel Aviv
Israel 1160.46.97204 Boehringer Ingelheim Investigational Site Tel Hashomer, Ramat Gan
Israel 1160.46.97201 Boehringer Ingelheim Investigational Site Zerifin
Italy 1160.46.39011 Boehringer Ingelheim Investigational Site Catania
Italy 1160.46.39015 Boehringer Ingelheim Investigational Site Firenze
Italy 1160.46.39012 Boehringer Ingelheim Investigational Site Palermo
Italy 1160.46.39007 Boehringer Ingelheim Investigational Site Reggio Emilia
Italy 1160.46.39013 Boehringer Ingelheim Investigational Site Verona
Italy 1160.46.39005 Boehringer Ingelheim Investigational Site Vittorio Veneto (TV)
Korea, Republic of 1160.46.82007 Boehringer Ingelheim Investigational Site Busan
Korea, Republic of 1160.46.82003 Boehringer Ingelheim Investigational Site Goyang-si
Korea, Republic of 1160.46.82008 Boehringer Ingelheim Investigational Site Gyeonggi-do
Korea, Republic of 1160.46.82010 Boehringer Ingelheim Investigational Site Gyeonggi-do
Korea, Republic of 1160.46.82002 Boehringer Ingelheim Investigational Site Kyunggi-do
Korea, Republic of 1160.46.82004 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.46.82005 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.46.82006 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1160.46.82009 Boehringer Ingelheim Investigational Site Seoul
Malaysia 1160.46.60001 Boehringer Ingelheim Investigational Site Kelantan Kota Bahru
Malaysia 1160.46.60003 Boehringer Ingelheim Investigational Site Melaka
Malaysia 1160.46.60004 Boehringer Ingelheim Investigational Site Pahang
Malaysia 1160.46.60002 Boehringer Ingelheim Investigational Site Selangor
Netherlands 1160.46.31017 Boehringer Ingelheim Investigational Site Alkmaar
Netherlands 1160.46.31001 Boehringer Ingelheim Investigational Site Amersfoort
Netherlands 1160.46.31010 Boehringer Ingelheim Investigational Site Den Bosch
Netherlands 1160.46.31013 Boehringer Ingelheim Investigational Site Eindhoven
Netherlands 1160.46.31014 Boehringer Ingelheim Investigational Site Heerlen
Netherlands 1160.46.31002 Boehringer Ingelheim Investigational Site Nieuwegein
Netherlands 1160.46.31004 Boehringer Ingelheim Investigational Site Rotterdam
Netherlands 1160.46.31015 Boehringer Ingelheim Investigational Site Zwolle
New Zealand 1160.46.64004 Boehringer Ingelheim Investigational Site Christchurch
New Zealand 1160.46.64003 Boehringer Ingelheim Investigational Site Grafton Auckland
New Zealand 1160.46.64002 Boehringer Ingelheim Investigational Site Otahuhu Auckland
New Zealand 1160.46.64001 Boehringer Ingelheim Investigational Site Takapuna Auckland
Norway 1160.46.47001 Boehringer Ingelheim Investigational Site Oslo
Norway 1160.46.47005 Boehringer Ingelheim Investigational Site Trondheim
Philippines 1160.46.63001 Boehringer Ingelheim Investigational Site Manila
Philippines 1160.46.63005 Boehringer Ingelheim Investigational Site Muntinlupa
Philippines 1160.46.63003 Boehringer Ingelheim Investigational Site Quezon City
Philippines 1160.46.63004 Boehringer Ingelheim Investigational Site Quezon City
Poland 1160.46.48004 Boehringer Ingelheim Investigational Site Kielce
Poland 1160.46.48001 Boehringer Ingelheim Investigational Site Krakow
Poland 1160.46.48005 Boehringer Ingelheim Investigational Site Krakow
Poland 1160.46.48003 Boehringer Ingelheim Investigational Site Poznan
Poland 1160.46.48006 Boehringer Ingelheim Investigational Site Warsaw
Russian Federation 1160.46.07021 Boehringer Ingelheim Investigational Site Chelyabinsk
Russian Federation 1160.46.07007 Boehringer Ingelheim Investigational Site Ekaterinburg
Russian Federation 1160.46.07016 Boehringer Ingelheim Investigational Site Krasnodar
Russian Federation 1160.46.07004 Boehringer Ingelheim Investigational Site Kursk
Russian Federation 1160.46.07009 Boehringer Ingelheim Investigational Site Rostov-na-Donu
Russian Federation 1160.46.07024 Boehringer Ingelheim Investigational Site Rostov-na-Donu
Russian Federation 1160.46.07014 Boehringer Ingelheim Investigational Site Ufa
Russian Federation 1160.46.07005 Boehringer Ingelheim Investigational Site Yaroslavl
Russian Federation 1160.46.07006 Boehringer Ingelheim Investigational Site Yaroslavl
Singapore 1160.46.65001 Boehringer Ingelheim Investigational Site Singapore
Singapore 1160.46.65002 Boehringer Ingelheim Investigational Site Singapore
Singapore 1160.46.65003 Boehringer Ingelheim Investigational Site Singapore
Slovakia 1160.46.42107 Boehringer Ingelheim Investigational Site Banska Bystrica
Slovakia 1160.46.42106 Boehringer Ingelheim Investigational Site Lucenec
Slovakia 1160.46.42102 Boehringer Ingelheim Investigational Site Nitra
Slovakia 1160.46.42103 Boehringer Ingelheim Investigational Site Nove Zamky
South Africa 1160.46.27001 Boehringer Ingelheim Investigational Site Bryanston
South Africa 1160.46.27013 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1160.46.27007 Boehringer Ingelheim Investigational Site Centurion
South Africa 1160.46.27014 Boehringer Ingelheim Investigational Site Kempton Park
South Africa 1160.46.27015 Boehringer Ingelheim Investigational Site Krugersdorp
South Africa 1160.46.27002 Boehringer Ingelheim Investigational Site Morningside
South Africa 1160.46.27012 Boehringer Ingelheim Investigational Site Plumstead
South Africa 1160.46.27006 Boehringer Ingelheim Investigational Site Sunninghill
Spain 1160.46.34002 Boehringer Ingelheim Investigational Site Barcelona
Spain 1160.46.34007 Boehringer Ingelheim Investigational Site Cartagena. Murcia
Spain 1160.46.34009 Boehringer Ingelheim Investigational Site Madrid
Spain 1160.46.34015 Boehringer Ingelheim Investigational Site Palma de Mallorca
Spain 1160.46.34014 Boehringer Ingelheim Investigational Site Sabadell - barcelona
Spain 1160.46.34011 Boehringer Ingelheim Investigational Site Valencia
Sweden 1160.46.46002 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1160.46.46010 Boehringer Ingelheim Investigational Site Kristianstad
Sweden 1160.46.46001 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.46.46008 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1160.46.46003 Boehringer Ingelheim Investigational Site Uppsala
Taiwan 1160.46.88607 Boehringer Ingelheim Investigational Site ChangHua
Taiwan 1160.46.88604 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.46.88606 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.46.88608 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1160.46.88609 Boehringer Ingelheim Investigational Site Taipei
Thailand 1160.46.66007 Boehringer Ingelheim Investigational Site Bangkok
Thailand 1160.46.66010 Boehringer Ingelheim Investigational Site Bangkok
Thailand 1160.46.66001 Boehringer Ingelheim Investigational Site Khon Kaen
Thailand 1160.46.66004 Boehringer Ingelheim Investigational Site Muang Nakhonratchasima
Thailand 1160.46.66005 Boehringer Ingelheim Investigational Site Nakhonratchasima
Thailand 1160.46.66006 Boehringer Ingelheim Investigational Site Nokorn Nayok
Thailand 1160.46.66008 Boehringer Ingelheim Investigational Site Phayathai
Turkey 1160.46.90003 Boehringer Ingelheim Investigational Site Ankara
Turkey 1160.46.90004 Boehringer Ingelheim Investigational Site Ankara
Turkey 1160.46.90001 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.46.90002 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.46.90007 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.46.90008 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.46.90009 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1160.46.90010 Boehringer Ingelheim Investigational Site Istanbul
Ukraine 1160.46.38005 Boehringer Ingelheim Investigational Site Vinnitsa
United Kingdom 1160.46.44005 Boehringer Ingelheim Investigational Site Headington, Oxford
United Kingdom 1160.46.44011 Boehringer Ingelheim Investigational Site London
United Kingdom 1160.46.44006 Boehringer Ingelheim Investigational Site Newcastle upon Tyne
United Kingdom 1160.46.44013 Boehringer Ingelheim Investigational Site Plymouth
United Kingdom 1160.46.44012 Boehringer Ingelheim Investigational Site Sheffield
United States 1160.46.01062 Boehringer Ingelheim Investigational Site Bellevue Washington
United States 1160.46.01059 Boehringer Ingelheim Investigational Site Bend Oregon
United States 1160.46.01044 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1160.46.01061 Boehringer Ingelheim Investigational Site Columbus Ohio
United States 1160.46.01063 Boehringer Ingelheim Investigational Site Corvallis Oregon
United States 1160.46.01073 Boehringer Ingelheim Investigational Site Little Rock Arkansas
United States 1160.46.01068 Boehringer Ingelheim Investigational Site Normal Illinois
United States 1160.46.01071 Boehringer Ingelheim Investigational Site Shreveport Louisiana
United States 1160.46.01060 Boehringer Ingelheim Investigational Site Stony Brook New York
United States 1160.46.01055 Boehringer Ingelheim Investigational Site Summerville South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  China,  Czech Republic,  Denmark,  France,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  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 ptp. 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 ptp. 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 ptp. 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 ptp. 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. Hazard ratios and 95% CI were not calculated because of insufficient number of events. From randomisation to 6 months (up to day 180) and 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 ptp. 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 Fatal and Non-fatal PE Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. 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 MBE, MBE and/or CRBE, and Any Bleeding Events Major bleeding events (MBE) are 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) are 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
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 Yes
Secondary Number of Participants With Acute Coronary Syndrome (ACS) Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings. From first intake of study drug to last contact date 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 No
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