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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00781391




Registration number
NCT00781391
Ethics application status
Date submitted
28/10/2008
Date registered
29/10/2008

Titles & IDs
Public title
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
Secondary ID [1] 0 0
DU176b-C-U301
Universal Trial Number (UTN)
Trial acronym
EngageAFTIMI48
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Atrial Fibrillation 0 0
Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - warfarin tablets
Treatment: Drugs - Edoxaban tablets (high dose regimen-60mg)
Treatment: Drugs - Edoxaban tablets (low dose regimen-30mg)
Treatment: Drugs - placebo warfarin
Treatment: Drugs - placebo edoxaban

Active comparator: Warfarin/placebo edoxaban - Warfarin tablets plus placebo Edoxaban tablets

Experimental: high dose edoxaban/placebo warfarin - Edoxaban tablets (60mg) plus warfarin placebo tablets

Experimental: low dose edoxaban/placebo warfarin - Edoxaban tablets (30mg) plus warfarin placebo tablets


Treatment: Drugs: warfarin tablets
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months

Treatment: Drugs: Edoxaban tablets (high dose regimen-60mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

Treatment: Drugs: Edoxaban tablets (low dose regimen-30mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

Treatment: Drugs: placebo warfarin
placebo warfarin

Treatment: Drugs: placebo edoxaban
placebo edoxaban

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Timepoint [1] 0 0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [2] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Timepoint [2] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [3] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Timepoint [3] 0 0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [4] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Timepoint [4] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Primary outcome [5] 0 0
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
Timepoint [5] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [1] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
Timepoint [1] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [2] 0 0
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
Timepoint [2] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [3] 0 0
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
Timepoint [3] 0 0
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcome [4] 0 0
Adjudicated Bleeding Events
Timepoint [4] 0 0
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Eligibility
Key inclusion criteria
* 21 years of age or older; male or female.
* Able to provide written informed consent.
* History of documented AF within the prior 12 months
* A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Transient atrial fibrillation secondary to other reversible disorders
* Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
* Subjects with any contraindication for anticoagulant agents;
* Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
* Females of childbearing potential including the following:

* Females with a history of tubal-ligation
* Females less than 2 years post-menopausal

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Broken Hill
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- East Gosford
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- Carina Heights
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- Milton
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- Adelaide
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- Frankston
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- Ashford
Recruitment hospital [8] 0 0
- Camperdown
Recruitment hospital [9] 0 0
- Elizabeth Vale
Recruitment hospital [10] 0 0
- Joondalup
Recruitment hospital [11] 0 0
- Melbourne
Recruitment hospital [12] 0 0
- Parkville
Recruitment hospital [13] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Broken Hill
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- East Gosford
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- Carina Heights
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- Milton
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- Adelaide
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- Frankston
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- Ashford
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- Camperdown
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- Elizabeth Vale
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- Joondalup
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- Melbourne
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- Parkville
Recruitment postcode(s) [13] 0 0
- Perth
Recruitment outside Australia
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Finland
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Finland
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Finland
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Finland
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France
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France
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Amiens Cedex
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France
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France
State/province [222] 0 0
Cambrai
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France
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Clamart
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France
State/province [224] 0 0
La Roche sur Yon
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France
State/province [225] 0 0
Lille
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France
State/province [226] 0 0
Lyon Cedex
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France
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Massy
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France
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Nantes
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France
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Paris
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France
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Pau
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France
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Pessac
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France
State/province [232] 0 0
Poitiers
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France
State/province [233] 0 0
Tours Cedex
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France
State/province [234] 0 0
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Germany
State/province [235] 0 0
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Germany
State/province [236] 0 0
Aschaffenburg
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Germany
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Germany
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Bad Nauheim
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Germany
State/province [239] 0 0
Berlin
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Germany
State/province [240] 0 0
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Germany
State/province [241] 0 0
Cloppenburg
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Germany
State/province [242] 0 0
Dortmund
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Germany
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Dresden
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Germany
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Germany
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Frankfurt
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Germany
State/province [246] 0 0
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Germany
State/province [247] 0 0
Goerlitz
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Germany
State/province [248] 0 0
Grossheirath
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Germany
State/province [249] 0 0
Hamburg
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Germany
State/province [250] 0 0
Heidelberg
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Germany
State/province [251] 0 0
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Germany
State/province [252] 0 0
Homburg
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Germany
State/province [253] 0 0
Ingelheim
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Germany
State/province [254] 0 0
Kallstadt
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Germany
State/province [255] 0 0
Kassel
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Germany
State/province [256] 0 0
Kiel-Kronshagen
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Germany
State/province [257] 0 0
Koeln
Country [258] 0 0
Germany
State/province [258] 0 0
Leipzig
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Germany
State/province [259] 0 0
Ludwigshafen
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Germany
State/province [260] 0 0
Luebeck
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Germany
State/province [261] 0 0
Magdeburg
Country [262] 0 0
Germany
State/province [262] 0 0
Mainz
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Germany
State/province [263] 0 0
Mannheim
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Germany
State/province [264] 0 0
Markkleeberg
Country [265] 0 0
Germany
State/province [265] 0 0
Muenchen
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Germany
State/province [266] 0 0
Nienburg
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Germany
State/province [267] 0 0
Northeinm
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Germany
State/province [268] 0 0
Offenbach-beiber
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Germany
State/province [269] 0 0
Potsdam
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Germany
State/province [270] 0 0
Ruedersdorf
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Germany
State/province [271] 0 0
Siegen
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Germany
State/province [272] 0 0
Stuhr
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Germany
State/province [273] 0 0
Ulm
Country [274] 0 0
Germany
State/province [274] 0 0
Unterschneidheim
Country [275] 0 0
Germany
State/province [275] 0 0
Wardenburg
Country [276] 0 0
Germany
State/province [276] 0 0
Wermsdorf
Country [277] 0 0
Germany
State/province [277] 0 0
Weyhe
Country [278] 0 0
Germany
State/province [278] 0 0
Witten
Country [279] 0 0
Germany
State/province [279] 0 0
Woerishofen
Country [280] 0 0
Germany
State/province [280] 0 0
Wuppertal
Country [281] 0 0
Greece
State/province [281] 0 0
Athens
Country [282] 0 0
Greece
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Larissa
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Greece
State/province [283] 0 0
Rhodes
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Greece
State/province [284] 0 0
Rio-Patras
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Greece
State/province [285] 0 0
Thessaloniki
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Greece
State/province [286] 0 0
Trikala
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Greece
State/province [287] 0 0
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State/province [288] 0 0
Ciudad
Country [289] 0 0
Guatemala
State/province [289] 0 0
Clinica
Country [290] 0 0
Guatemala
State/province [290] 0 0
Edificio Multimedica
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Guatemala
State/province [291] 0 0
Nivel
Country [292] 0 0
Guatemala
State/province [292] 0 0
Oficina
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Guatemala
State/province [293] 0 0
Quetzaltenango
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Guatemala
State/province [294] 0 0
Zacapa
Country [295] 0 0
Hungary
State/province [295] 0 0
Ajka
Country [296] 0 0
Hungary
State/province [296] 0 0
Baja
Country [297] 0 0
Hungary
State/province [297] 0 0
Bekescsaba
Country [298] 0 0
Hungary
State/province [298] 0 0
Budapest
Country [299] 0 0
Hungary
State/province [299] 0 0
Debrecen
Country [300] 0 0
Hungary
State/province [300] 0 0
Hodmezovasarhely
Country [301] 0 0
Hungary
State/province [301] 0 0
Kecskemet
Country [302] 0 0
Hungary
State/province [302] 0 0
Keeskemet
Country [303] 0 0
Hungary
State/province [303] 0 0
Kistarcsa
Country [304] 0 0
Hungary
State/province [304] 0 0
Komarom
Country [305] 0 0
Hungary
State/province [305] 0 0
Mako
Country [306] 0 0
Hungary
State/province [306] 0 0
Nagykanizsa
Country [307] 0 0
Hungary
State/province [307] 0 0
Nyiregyhaza
Country [308] 0 0
Hungary
State/province [308] 0 0
Pecs
Country [309] 0 0
Hungary
State/province [309] 0 0
Sopron
Country [310] 0 0
Hungary
State/province [310] 0 0
Szekszard
Country [311] 0 0
Hungary
State/province [311] 0 0
Szombathely
Country [312] 0 0
Hungary
State/province [312] 0 0
Zalaegerszeg
Country [313] 0 0
India
State/province [313] 0 0
AP
Country [314] 0 0
India
State/province [314] 0 0
Kerala
Country [315] 0 0
India
State/province [315] 0 0
Ahmedabad
Country [316] 0 0
India
State/province [316] 0 0
Anddhra Pradesh
Country [317] 0 0
India
State/province [317] 0 0
Andhra Pradesh
Country [318] 0 0
India
State/province [318] 0 0
Aurangabad
Country [319] 0 0
India
State/province [319] 0 0
Bangalore
Country [320] 0 0
India
State/province [320] 0 0
Bikaner
Country [321] 0 0
India
State/province [321] 0 0
Chennai
Country [322] 0 0
India
State/province [322] 0 0
Coimbatore
Country [323] 0 0
India
State/province [323] 0 0
Delhi
Country [324] 0 0
India
State/province [324] 0 0
Gujrat
Country [325] 0 0
India
State/province [325] 0 0
Indore
Country [326] 0 0
India
State/province [326] 0 0
Jaipur
Country [327] 0 0
India
State/province [327] 0 0
Karnataka
Country [328] 0 0
India
State/province [328] 0 0
Kolkata
Country [329] 0 0
India
State/province [329] 0 0
Ludhiana
Country [330] 0 0
India
State/province [330] 0 0
Madhya Pradesh
Country [331] 0 0
India
State/province [331] 0 0
Maharashtra
Country [332] 0 0
India
State/province [332] 0 0
Mangalore
Country [333] 0 0
India
State/province [333] 0 0
Mumbai
Country [334] 0 0
India
State/province [334] 0 0
Nagpur
Country [335] 0 0
India
State/province [335] 0 0
Nashik
Country [336] 0 0
India
State/province [336] 0 0
New Delhi
Country [337] 0 0
India
State/province [337] 0 0
Pune
Country [338] 0 0
India
State/province [338] 0 0
Puni
Country [339] 0 0
India
State/province [339] 0 0
Punjab
Country [340] 0 0
India
State/province [340] 0 0
Rajasthan
Country [341] 0 0
India
State/province [341] 0 0
Ramnagar
Country [342] 0 0
India
State/province [342] 0 0
Shimoga
Country [343] 0 0
India
State/province [343] 0 0
Surat
Country [344] 0 0
India
State/province [344] 0 0
Trivandrum
Country [345] 0 0
India
State/province [345] 0 0
Vadodara
Country [346] 0 0
Israel
State/province [346] 0 0
Afula
Country [347] 0 0
Israel
State/province [347] 0 0
Beer-Sheva
Country [348] 0 0
Israel
State/province [348] 0 0
Dimona
Country [349] 0 0
Israel
State/province [349] 0 0
Givatayim
Country [350] 0 0
Israel
State/province [350] 0 0
Hadera
Country [351] 0 0
Israel
State/province [351] 0 0
Haifa
Country [352] 0 0
Israel
State/province [352] 0 0
Holon
Country [353] 0 0
Israel
State/province [353] 0 0
Jerusalem
Country [354] 0 0
Israel
State/province [354] 0 0
Kfar Saba
Country [355] 0 0
Israel
State/province [355] 0 0
Nahariya
Country [356] 0 0
Israel
State/province [356] 0 0
Nazareth
Country [357] 0 0
Israel
State/province [357] 0 0
Petach Tikva
Country [358] 0 0
Israel
State/province [358] 0 0
Petah-Tikva
Country [359] 0 0
Israel
State/province [359] 0 0
Poriya
Country [360] 0 0
Israel
State/province [360] 0 0
Raanana
Country [361] 0 0
Israel
State/province [361] 0 0
Rehovot
Country [362] 0 0
Israel
State/province [362] 0 0
Tel Aviv
Country [363] 0 0
Israel
State/province [363] 0 0
Tel Hashomer
Country [364] 0 0
Israel
State/province [364] 0 0
Zerifin
Country [365] 0 0
Italy
State/province [365] 0 0
Bologna
Country [366] 0 0
Italy
State/province [366] 0 0
Brescia
Country [367] 0 0
Italy
State/province [367] 0 0
Cantania
Country [368] 0 0
Italy
State/province [368] 0 0
Casarano
Country [369] 0 0
Italy
State/province [369] 0 0
Caserta
Country [370] 0 0
Italy
State/province [370] 0 0
Chieti
Country [371] 0 0
Italy
State/province [371] 0 0
Cremona
Country [372] 0 0
Italy
State/province [372] 0 0
Genova
Country [373] 0 0
Italy
State/province [373] 0 0
Grosseto
Country [374] 0 0
Italy
State/province [374] 0 0
Legnano
Country [375] 0 0
Italy
State/province [375] 0 0
Manerbio
Country [376] 0 0
Italy
State/province [376] 0 0
Milano
Country [377] 0 0
Italy
State/province [377] 0 0
Monserrato
Country [378] 0 0
Italy
State/province [378] 0 0
Napoli
Country [379] 0 0
Italy
State/province [379] 0 0
Novara
Country [380] 0 0
Italy
State/province [380] 0 0
Ostia
Country [381] 0 0
Italy
State/province [381] 0 0
Pavia
Country [382] 0 0
Italy
State/province [382] 0 0
Pisa
Country [383] 0 0
Italy
State/province [383] 0 0
Pozzuoli
Country [384] 0 0
Italy
State/province [384] 0 0
Roma
Country [385] 0 0
Italy
State/province [385] 0 0
Santa Maria Capua Vetere
Country [386] 0 0
Italy
State/province [386] 0 0
Sassari
Country [387] 0 0
Italy
State/province [387] 0 0
Seriate
Country [388] 0 0
Italy
State/province [388] 0 0
Siena
Country [389] 0 0
Italy
State/province [389] 0 0
Trieste
Country [390] 0 0
Italy
State/province [390] 0 0
Venezia Mestre
Country [391] 0 0
Japan
State/province [391] 0 0
Kyoto
Country [392] 0 0
Japan
State/province [392] 0 0
Nagano
Country [393] 0 0
Japan
State/province [393] 0 0
Tokyo
Country [394] 0 0
Japan
State/province [394] 0 0
Aichi
Country [395] 0 0
Japan
State/province [395] 0 0
Aomori
Country [396] 0 0
Japan
State/province [396] 0 0
Chiaki
Country [397] 0 0
Japan
State/province [397] 0 0
Chiba
Country [398] 0 0
Japan
State/province [398] 0 0
Ehime
Country [399] 0 0
Japan
State/province [399] 0 0
Fukuoka
Country [400] 0 0
Japan
State/province [400] 0 0
Fukushima
Country [401] 0 0
Japan
State/province [401] 0 0
Gifu
Country [402] 0 0
Japan
State/province [402] 0 0
Gunma
Country [403] 0 0
Japan
State/province [403] 0 0
Hiroshima
Country [404] 0 0
Japan
State/province [404] 0 0
Hokkai-do
Country [405] 0 0
Japan
State/province [405] 0 0
Hokkaido
Country [406] 0 0
Japan
State/province [406] 0 0
Hyogo
Country [407] 0 0
Japan
State/province [407] 0 0
Ibaraki
Country [408] 0 0
Japan
State/province [408] 0 0
Isesaki-shi
Country [409] 0 0
Japan
State/province [409] 0 0
Ishikawa
Country [410] 0 0
Japan
State/province [410] 0 0
Iwate
Country [411] 0 0
Japan
State/province [411] 0 0
Kagawa
Country [412] 0 0
Japan
State/province [412] 0 0
Kanagawa
Country [413] 0 0
Japan
State/province [413] 0 0
Kumamoto
Country [414] 0 0
Japan
State/province [414] 0 0
Kyota
Country [415] 0 0
Japan
State/province [415] 0 0
Mie
Country [416] 0 0
Japan
State/province [416] 0 0
Miyagi
Country [417] 0 0
Japan
State/province [417] 0 0
Nagaoka-shi
Country [418] 0 0
Japan
State/province [418] 0 0
Nagasaki
Country [419] 0 0
Japan
State/province [419] 0 0
Niigata
Country [420] 0 0
Japan
State/province [420] 0 0
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Country [421] 0 0
Japan
State/province [421] 0 0
Osaka
Country [422] 0 0
Japan
State/province [422] 0 0
Saitama
Country [423] 0 0
Japan
State/province [423] 0 0
Shimane
Country [424] 0 0
Japan
State/province [424] 0 0
Shizuoka
Country [425] 0 0
Japan
State/province [425] 0 0
Tokushima
Country [426] 0 0
Japan
State/province [426] 0 0
Yamaguchi
Country [427] 0 0
Japan
State/province [427] 0 0
Yokohama-shi
Country [428] 0 0
Korea, Republic of
State/province [428] 0 0
Busan
Country [429] 0 0
Korea, Republic of
State/province [429] 0 0
Daegu
Country [430] 0 0
Korea, Republic of
State/province [430] 0 0
Daejeon
Country [431] 0 0
Korea, Republic of
State/province [431] 0 0
Gangwon-do
Country [432] 0 0
Korea, Republic of
State/province [432] 0 0
Gwangju-si
Country [433] 0 0
Korea, Republic of
State/province [433] 0 0
Gyeonggi-do
Country [434] 0 0
Korea, Republic of
State/province [434] 0 0
Incheon
Country [435] 0 0
Korea, Republic of
State/province [435] 0 0
Pusan
Country [436] 0 0
Korea, Republic of
State/province [436] 0 0
Seoul
Country [437] 0 0
Mexico
State/province [437] 0 0
Jalisco
Country [438] 0 0
Mexico
State/province [438] 0 0
Veracruz
Country [439] 0 0
Mexico
State/province [439] 0 0
Aguascalientes
Country [440] 0 0
Mexico
State/province [440] 0 0
Chihuahua
Country [441] 0 0
Mexico
State/province [441] 0 0
Distrito Federal
Country [442] 0 0
Mexico
State/province [442] 0 0
Durango
Country [443] 0 0
Mexico
State/province [443] 0 0
Monterrey
Country [444] 0 0
Mexico
State/province [444] 0 0
San Luis Potosi
Country [445] 0 0
Mexico
State/province [445] 0 0
Yucatan
Country [446] 0 0
Netherlands
State/province [446] 0 0
Almere
Country [447] 0 0
Netherlands
State/province [447] 0 0
Amstelveen
Country [448] 0 0
Netherlands
State/province [448] 0 0
Amsterdam
Country [449] 0 0
Netherlands
State/province [449] 0 0
Dordrecht
Country [450] 0 0
Netherlands
State/province [450] 0 0
Eindhoven
Country [451] 0 0
Netherlands
State/province [451] 0 0
Ewijk
Country [452] 0 0
Netherlands
State/province [452] 0 0
Leiderdorp
Country [453] 0 0
Netherlands
State/province [453] 0 0
Maastricht
Country [454] 0 0
Netherlands
State/province [454] 0 0
Rotterdam
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Netherlands
State/province [455] 0 0
Venlo
Country [456] 0 0
Netherlands
State/province [456] 0 0
Wildervlank
Country [457] 0 0
New Zealand
State/province [457] 0 0
Wellington
Country [458] 0 0
New Zealand
State/province [458] 0 0
Auckland
Country [459] 0 0
New Zealand
State/province [459] 0 0
Christchurch
Country [460] 0 0
New Zealand
State/province [460] 0 0
Dunedin
Country [461] 0 0
New Zealand
State/province [461] 0 0
Hamilton
Country [462] 0 0
New Zealand
State/province [462] 0 0
Nelson
Country [463] 0 0
New Zealand
State/province [463] 0 0
Tauranga
Country [464] 0 0
Norway
State/province [464] 0 0
Bodo
Country [465] 0 0
Norway
State/province [465] 0 0
Harstad
Country [466] 0 0
Norway
State/province [466] 0 0
Haugesund
Country [467] 0 0
Norway
State/province [467] 0 0
Oslo
Country [468] 0 0
Norway
State/province [468] 0 0
Rud
Country [469] 0 0
Peru
State/province [469] 0 0
Arequipa
Country [470] 0 0
Peru
State/province [470] 0 0
Callao
Country [471] 0 0
Peru
State/province [471] 0 0
Lima
Country [472] 0 0
Philippines
State/province [472] 0 0
Cebu City
Country [473] 0 0
Philippines
State/province [473] 0 0
Cebu
Country [474] 0 0
Philippines
State/province [474] 0 0
Davao City
Country [475] 0 0
Philippines
State/province [475] 0 0
Pasig City
Country [476] 0 0
Philippines
State/province [476] 0 0
Quezon City
Country [477] 0 0
Poland
State/province [477] 0 0
Mazowiecka
Country [478] 0 0
Poland
State/province [478] 0 0
Bydgoszcz
Country [479] 0 0
Poland
State/province [479] 0 0
Chojnice
Country [480] 0 0
Poland
State/province [480] 0 0
Elblag
Country [481] 0 0
Poland
State/province [481] 0 0
Elk
Country [482] 0 0
Poland
State/province [482] 0 0
Gdansk
Country [483] 0 0
Poland
State/province [483] 0 0
Inowroclaw
Country [484] 0 0
Poland
State/province [484] 0 0
Jaroslaw
Country [485] 0 0
Poland
State/province [485] 0 0
Katowice
Country [486] 0 0
Poland
State/province [486] 0 0
Kolobrzeg
Country [487] 0 0
Poland
State/province [487] 0 0
Komenskiego
Country [488] 0 0
Poland
State/province [488] 0 0
Krakow
Country [489] 0 0
Poland
State/province [489] 0 0
Kutno
Country [490] 0 0
Poland
State/province [490] 0 0
Libiaz
Country [491] 0 0
Poland
State/province [491] 0 0
Lodz
Country [492] 0 0
Poland
State/province [492] 0 0
Lubartow
Country [493] 0 0
Poland
State/province [493] 0 0
Lublin
Country [494] 0 0
Poland
State/province [494] 0 0
Plock
Country [495] 0 0
Poland
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Surrey
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Wolverhampton
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The TIMI Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.