Clinical trial NCT00986154: Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
Official title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Thromboembolism
Venous Thrombosis
Keywords: Recurrent Thrombosis
Recurrent Pulmonary Embolism
Symptomatic Deep Vein Thrombosis
Symptomatic Pulmonary Embolism
Venous Thromboembolism (VTE)
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 8292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects older than the minimum legal adult age (country specific);
* Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
* Able to provide written informed consent

Exclusion Criteria:

* thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
* More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
* Calculated Creatinine clearance (CrCL) \< 30 mL/min;
* significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
* patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
* active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
* chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
* treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
* concurrent treatment with potent P-gp inhibitors;
* subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study

Primary outcomes:
measure: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
timeFrame: 12 months from time of randomization
Secondary outcomes:
measure: The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
timeFrame: 12 months from time of randomization
measure: Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
timeFrame: 12 months from time of randomization
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Investigational Site 7103
state: Alabama
city: Montgomery
country: United States
facility: Investigational Site 7132
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site 7126
state: Arizona
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facility: Investigational Site 1005
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city: Orlando
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city: Sarasota
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facility: Investigational Site 2902
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country: Canada
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country: Chile
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country: Chile
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country: China
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country: China
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country: China
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country: China
facility: Investigational Site 4316
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country: China
city: Jiangsu
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facility: Investigational Site 1902
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city: Ostrava
country: Czechia
facility: Investigational Site 1905
city: Plzen
country: Czechia
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city: Plzen
country: Czechia
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city: Praha
country: Czechia
facility: Investigational Site 1904
city: Usti Nad Labem
country: Czechia
city: Aarhus
country: Denmark
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country: Denmark
city: Copenhagen
country: Denmark
city: Herlev
country: Denmark
facility: Investigational Site 6003
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city: Svendborg
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facility: Investigational Site 6001
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country: Estonia
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city: Tartu
country: Estonia
facility: Investigational Site 2102
city: Agen
country: France
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city: Amiens
country: France
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city: Angers
country: France
facility: Investigational Site 3311
city: Annecy
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city: Arras
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facility: Investigational Site 3329
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city: Cannes
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city: Dijon
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city: Hetztessy
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facility: Investigational Site 3325
city: Le Mans
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city: Lille
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city: Lyon
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city: Nantes
country: France
city: Nice
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city: Paris
country: France
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city: Paris
country: France
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city: Paris
country: France
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city: Pessac
country: France
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city: Pessac
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country: France
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city: Roskilde
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country: France
facility: Investigational Site 3305
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city: Berlin
country: Germany
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city: Darmstadt
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city: Dresden
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city: Hamburg
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city: Magdeburg
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city: Mainz
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city: Munchen
country: Germany
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city: Nordhausen
country: Germany
facility: Investigational Site 1714
city: Paderborn
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city: Tubingen
country: Germany
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city: Witten
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city: Baja
country: Hungary
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city: Budapest
country: Hungary
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city: Budapest
country: Hungary
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country: Hungary
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city: Debrecen
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city: Kistarcsa
country: Hungary
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city: Maglodi
country: Hungary
city: Miskolc
country: Hungary
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city: Pecs
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facility: Investigational Site 5410
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city: Szentes
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city: Szombathely
country: Hungary
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city: Zalaegerszeg
country: Hungary
facility: Investigational Site 5412
city: Zrinyi
country: Hungary
city: Ahmedabad
country: India
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country: India
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country: India
facility: Investigational Site 4402
city: Bangalore
country: India
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country: India
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country: India
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city: Bangalore
country: India
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country: India
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city: Gujarat
country: India
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country: India
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country: India
city: Holon
country: India
facility: Investigational Site 5514
city: Hyderabad
country: India
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city: Hyderabad
country: India
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city: Hyderabad
country: India
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country: India
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city: Karnataka
country: India
city: Kerala
country: India
city: Lucknow
country: India
facility: Investigational Site 4420
city: Madhya Pradesh
country: India
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country: India
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country: India
facility: Investigational Site 4409
city: Mumbai
country: India
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city: New Delhi
country: India
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city: New Delhi
country: India
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country: India
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city: Pune
country: India
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country: India
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city: Pune
country: India
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country: India
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city: Punjab
country: India
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country: India
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country: India
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city: Tamil Nadu
country: India
city: Uttar Pradesh
country: India
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country: India
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country: India
city: Afula
country: Israel
city: Ashkelon
country: Israel
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country: Israel
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country: Israel
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city: Haifa
country: Israel
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city: Holon
country: Israel
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city: Jerusalem
country: Israel
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city: Kfar Saba
country: Israel
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city: Nahariya
country: Israel
facility: Investigational Site 5513
city: Petah-Tikva
country: Israel
facility: Investigational Site 5510
city: Poriya
country: Israel
facility: Investigational Site 5512
city: Tel Aviv
country: Israel
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city: Tel Hashomer
country: Israel
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city: Bergamo
country: Italy
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city: Chieti
country: Italy
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city: Emilia
country: Italy
facility: Investigational Site 3500
city: Milano
country: Italy
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city: Padova
country: Italy
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country: Italy
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country: Italy
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city: Pavia
country: Italy
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city: Rozzano
country: Italy
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city: Udine
country: Italy
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city: Varese
country: Italy
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city: Venezia
country: Italy
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city: Aichi
country: Japan
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city: Aomori
country: Japan
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city: Chiba
country: Japan
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city: Fukuoka
country: Japan
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city: Fukuoka
country: Japan
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country: Japan
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city: Hiroshima
country: Japan
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city: Hokkaido
country: Japan
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city: Hokkaido
country: Japan
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city: Hyogo
country: Japan
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city: Hyogo
country: Japan
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country: Japan
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city: Kagoshima
country: Japan
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city: Kanagawa
country: Japan
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city: Kumamoto
country: Japan
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city: Kumamoto
country: Japan
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city: Kumamoto
country: Japan
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city: Mie
country: Japan
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city: Nagano
country: Japan
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country: Japan
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city: Niigata
country: Japan
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city: Okayama
country: Japan
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city: Okinawa
country: Japan
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city: Osaka
country: Japan
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city: Sapporo
country: Japan
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city: Shizuoka
country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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country: Japan
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city: Tokyo
country: Japan
facility: Investigational Site 6142
city: Tokyo
country: Japan
facility: Investigational Site 6145
city: Tottori
country: Japan
facility: Investigational Site 6149
city: Busan
country: Korea, Republic of
facility: Investigational Site 4513
city: Daegu
country: Korea, Republic of
facility: Investigational Site 4509
city: Gyeonggi-do
country: Korea, Republic of
facility: Investigational Site 4501
city: Seoul
country: Korea, Republic of
facility: Investigational Site 4506
city: Seoul
country: Korea, Republic of
facility: Investigational Site 4507
city: Seoul
country: Korea, Republic of
facility: Investigational Site 4508
city: Seoul
country: Korea, Republic of
facility: Investigational Site 4515
city: Zapopan
country: Mexico
facility: Investigational Site 1303
state: Jalisco
city: Monterrey
country: Mexico
facility: Investigational Site 1302
state: Nuevo Leon
city: Col. Lomas Altas C.P
country: Mexico
facility: Investigational Site 1311
city: Guadalajara
country: Mexico
facility: Investigational Site 1304
city: Guadalajara
country: Mexico
facility: Investigational Site 1312
city: Hermosillo
country: Mexico
facility: Investigational Site 1300
city: Monterrey, Nuevo Leon
country: Mexico
facility: Investigational Site 1305
city: San Luis Potosi
country: Mexico
facility: Investigational Site 1308
city: Yucatan
country: Mexico
facility: Investigational Site 1301
city: Alkmaar
country: Netherlands
facility: Investigational Site 3608
city: Almere
country: Netherlands
facility: Investigational Site 3607
city: Amersfoort
country: Netherlands
facility: Investigational Site 3617
city: Amsterdam
country: Netherlands
facility: Investigational Site 3611
city: Assen
country: Netherlands
facility: Investigational Site 3609
city: Groningen
country: Netherlands
facility: Investigational Site 3603
city: Heerlen
country: Netherlands
facility: Investigational Site 3612
city: Hoofddorp
country: Netherlands
facility: Investigational Site 3613
city: Nijmegen
country: Netherlands
facility: Investigational Site 3602
city: Rotterdam
country: Netherlands
facility: Investigational Site 3615
city: Auckland
country: New Zealand
facility: Investigational Site 4702
city: Auckland
country: New Zealand
facility: Investigational Site 4703
city: Christchurch
country: New Zealand
facility: Investigational Site 4700
city: Wellington
country: New Zealand
facility: Investigational Site 4704
city: Fredrikstad
country: Norway
facility: Investigational Site 3701
city: Oslo
country: Norway
facility: Investigational Site 3700
city: Pasig City
country: Philippines
city: Quezon City
country: Philippines
facility: Investigational Site 4800
city: Quezon City
country: Philippines
facility: Investigational site 4801
city: Quezon City
country: Philippines
facility: Investigational Site 4802
city: Bialystok
country: Poland
facility: Investigational Site 5015
city: Krakow
country: Poland
facility: Investigational Site 5005
city: Olsztyn
country: Poland
facility: Investigational Site 5019
city: Tarnow
country: Poland
facility: Investigational Site 5018
city: Warszawa
country: Poland
facility: Investigational Site 5003
city: Warszawa
country: Poland
facility: Investigational Site 5007
city: Warszawa
country: Poland
facility: Investigational Site 5008
city: Warszawa
country: Poland
facility: Investigational Site 5014
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site 3023
city: Irkutsk
country: Russian Federation
facility: Investigational Site 3017
city: Kemerovo
country: Russian Federation
facility: Investigational Site 3019
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site 3020
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site 3030
city: Moscow
country: Russian Federation
facility: Investigational Site 3029
city: Novosibirsk
country: Russian Federation
facility: Investigational Site 3028
city: Omsk
country: Russian Federation
facility: Investigational Site 3009
city: Ryazan
country: Russian Federation
facility: Investigational Site 3022
city: Saratov
country: Russian Federation
city: Sochi
country: Russian Federation
facility: Investigational Site 3024
city: St. Petersburg
country: Russian Federation
facility: Investigational Site 3000
city: St. Petersburg
country: Russian Federation
facility: Investigational Site 3003
city: St. Petersburg
country: Russian Federation
facility: Investigational Site 3027
city: Tyumen
country: Russian Federation
facility: Investigational Site 3025
city: Ufa
country: Russian Federation
facility: Investigational Site 3016
city: Yaroslavl
country: Russian Federation
facility: Investigational Site 3004
city: Yaroslavl
country: Russian Federation
facility: Investigational Site 3010
city: Outram Road
country: Singapore
facility: Investigational Site 5900
city: Singapore
country: Singapore
facility: Investigational Site 5902
city: Cape Town
country: South Africa
facility: Investigational Site 4912
city: Centurion
country: South Africa
facility: Investigational Site 4907
city: Johannesburg
country: South Africa
facility: Investigational Site 4901
city: Johannesburg
country: South Africa
facility: Investigational Site 4905
city: Johannesburg
country: South Africa
facility: Investigational Site 4909
city: Johannesburg
country: South Africa
facility: Investigational Site 4910
city: Lyttleton
country: South Africa
facility: Investigational Site 4908
city: Pretoria
country: South Africa
facility: Investigational Site 4903
city: Pretoria
country: South Africa
facility: Investigational Site 4906
city: Somerset West
country: South Africa
facility: Investigational Site 4904
city: Worcester
country: South Africa
facility: Investigational Site 4900
city: Barcelona
country: Spain
facility: Investigational site 1503
city: Cabra
country: Spain
facility: Investigational Site 1502
city: Hallingsjo
country: Sweden
facility: Investigational Site 3900
city: Kristianstad
country: Sweden
facility: Investigational Site 3904
city: Stockholm
country: Sweden
facility: Investigational Site 3903
city: Stockholm
country: Sweden
facility: Investigational Site 3905
city: Sundsvall
country: Sweden
facility: Investigational Site 3902
city: Aarau
country: Switzerland
facility: Investigational Site 4103
city: Basel
country: Switzerland
facility: Investigational Site 4110
city: Bellinzona
country: Switzerland
facility: Investigational Site 4104
city: Chur
country: Switzerland
facility: Investigational Site 4102
city: Lausanne
country: Switzerland
facility: Investigational Site 4109
city: Luzern
country: Switzerland
facility: Investigational Site 4100
city: Hualien City
country: Taiwan
city: Kaohsiung
country: Taiwan
facility: Investigational Site 5104
city: Taichung
country: Taiwan
facility: Investigational Site 5105
city: Taipei
country: Taiwan
facility: Investigational Site 5101
city: Taipei
country: Taiwan
facility: Investigational Site 5103
city: Bangkok
country: Thailand
facility: Investigational Site 5200
city: Bangkok
country: Thailand
facility: Investigational Site 5202
city: Nakhorn Nayok
country: Thailand
facility: Investigational Site 5203
city: Ankara
country: Turkey
facility: Investigational Site 5702
city: Ankara
country: Turkey
facility: Investigational Site 5703
city: Istanbul
country: Turkey
facility: Investigational Site 5702
city: Istanbul
country: Turkey
facility: Investigational Site 5706
city: Chernigiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site 4008
city: Donetsk
country: Ukraine
facility: Investigational Site 4010
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site 4000
city: Kharkiv
country: Ukraine
facility: Investigational Site 4002
city: Kiev
country: Ukraine
facility: Investigational Site 4001
city: Ternopil
country: Ukraine
facility: Investigational Site 4007
city: Uzhgorod
country: Ukraine
facility: Investigational Site 4009
city: Vinnitsya
country: Ukraine
facility: Investigational Site 4003
city: Zaporizhzhia
country: Ukraine
facility: Investigational Site 4006
city: Coventry
country: United Kingdom
facility: Investigational Site 7005
city: Hull
country: United Kingdom
facility: Investigational Site 7006
city: London
country: United Kingdom
facility: Investigational Site 7000
city: London
country: United Kingdom
facility: Investigational Site 7003
city: London
country: United Kingdom
facility: Investigational Site 7004
city: Newcastle
country: United Kingdom
facility: Investigational Site 7001
city: Plymouth
country: United Kingdom
facility: Investigational Site 7007
Study officials:
References:
citation: Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.
citation: Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.
citation: Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.
citation: Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.
citation: Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.
citation: Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
citation: Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.