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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05757869
Registration number
NCT05757869
Ethics application status
Date submitted
24/02/2023
Date registered
7/03/2023
Titles & IDs
Public title
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
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Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
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Secondary ID [1]
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70033093AFL3002
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Secondary ID [2]
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CR109220
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Universal Trial Number (UTN)
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Trial acronym
LIBREXIA-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Milvexian
Treatment: Drugs - Apixaban
Treatment: Drugs - Placebo
Treatment: Drugs - Apixaban Placebo
Experimental: Milvexian - Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.
Active comparator: Apixaban - Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.
Treatment: Drugs: Milvexian
Milvexian will be administered orally.
Treatment: Drugs: Apixaban
Apixaban will be administered orally.
Treatment: Drugs: Placebo
Milvexian matching milvexian placebo will be administered orally.
Treatment: Drugs: Apixaban Placebo
Apixaban matching apixaban placebo will be administered orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
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Assessment method [1]
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Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.
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Timepoint [1]
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Up to 4 years
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Secondary outcome [1]
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Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding
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Assessment method [1]
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Time to the first occurrence of ISTH major bleeding will be reported.
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Timepoint [1]
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Up to 4 years
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Secondary outcome [2]
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Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding
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Assessment method [2]
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Time to the first occurrence of the composite of ISTH major and CRNM bleeding will be reported.
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Timepoint [2]
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Up to 4 years
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Secondary outcome [3]
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Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism
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Assessment method [3]
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Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism will be reported.
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Timepoint [3]
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Up to 4 years
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Secondary outcome [4]
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Time to CV Death
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Assessment method [4]
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Time to CV death will be reported.
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Timepoint [4]
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Up to 4 years
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Secondary outcome [5]
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Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism
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Assessment method [5]
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Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and Non-CNS systemic embolism will be reported.
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Timepoint [5]
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Up to 4 years
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Secondary outcome [6]
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Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature
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Assessment method [6]
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Time to the first occurrence of composite endpoint of CV death, MI, stroke, ALI \[any unanticipated revascularization or amputation of ischemic limb\]), and urgent hospitalization for vascular cause of ischemic nature (including deep vein thrombosis \[DVT\] and pulmonary embolism \[PE\]) will be reported.
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Timepoint [6]
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Up to 4 years
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Eligibility
Key inclusion criteria
* Minimum age of 18 years
* Medically stable and appropriate for chronic antithrombotic treatment
* Atrial fibrillation eligible to receive anticoagulation
* Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
* Any condition other than AF that requires chronic anticoagulation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/05/2027
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Actual
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Sample size
Target
15500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Adelaide
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Advara HeartCare Wesley - Brisbane
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Concord Repatriation General Hospital - Concord
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Peninsula Heart Center - Frankston
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Royal Brisbane and Women's Hospital - Herston
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GenesisCare Joondalup-Shenton House - Joondalup
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Novatrials - Kotara
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GenesisCare - Leabrook
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Core Research Group - Milton
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Brisbane Health Connect - Tarragindi
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5042 - Adelaide
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4066 - Brisbane
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2139 - Concord
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3199 - Frankston
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4029 - Herston
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6027 - Joondalup
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2289 - Kotara
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5068 - Leabrook
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4064 - Milton
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4121 - Tarragindi
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Recruitment outside Australia
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0
0
China
Query!
State/province [117]
0
0
Huhehaote
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Jieyang
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Jinan
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Jining
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Lanzhou
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Nanchang
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Ningbo
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Shanghai
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Shenyang
Query!
Country [126]
0
0
China
Query!
State/province [126]
0
0
Shijiazhuang
Query!
Country [127]
0
0
China
Query!
State/province [127]
0
0
Suzhou
Query!
Country [128]
0
0
China
Query!
State/province [128]
0
0
Taiyuan
Query!
Country [129]
0
0
China
Query!
State/province [129]
0
0
Taizhou
Query!
Country [130]
0
0
China
Query!
State/province [130]
0
0
Tianjin
Query!
Country [131]
0
0
China
Query!
State/province [131]
0
0
Wenzhou
Query!
Country [132]
0
0
China
Query!
State/province [132]
0
0
Wuhan
Query!
Country [133]
0
0
China
Query!
State/province [133]
0
0
Xinxiang
Query!
Country [134]
0
0
China
Query!
State/province [134]
0
0
Yangzhou
Query!
Country [135]
0
0
China
Query!
State/province [135]
0
0
Yantai
Query!
Country [136]
0
0
China
Query!
State/province [136]
0
0
Yinchuan
Query!
Country [137]
0
0
China
Query!
State/province [137]
0
0
Zhanjiang
Query!
Country [138]
0
0
China
Query!
State/province [138]
0
0
Zhengzhou
Query!
Country [139]
0
0
China
Query!
State/province [139]
0
0
Zunyi
Query!
Country [140]
0
0
Croatia
Query!
State/province [140]
0
0
Dubrovnik
Query!
Country [141]
0
0
Croatia
Query!
State/province [141]
0
0
Karlovac
Query!
Country [142]
0
0
Croatia
Query!
State/province [142]
0
0
Krapinske Toplice
Query!
Country [143]
0
0
Croatia
Query!
State/province [143]
0
0
Varazdin
Query!
Country [144]
0
0
Croatia
Query!
State/province [144]
0
0
Zagreb
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Bilovec
Query!
Country [146]
0
0
Czechia
Query!
State/province [146]
0
0
Brandys nad Labem
Query!
Country [147]
0
0
Czechia
Query!
State/province [147]
0
0
Brandýs nad Labem
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Brno
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
Broumov
Query!
Country [150]
0
0
Czechia
Query!
State/province [150]
0
0
Ceske Budejovice
Query!
Country [151]
0
0
Czechia
Query!
State/province [151]
0
0
Chomutov
Query!
Country [152]
0
0
Czechia
Query!
State/province [152]
0
0
Chrudim
Query!
Country [153]
0
0
Czechia
Query!
State/province [153]
0
0
Jablonec nad Nisou
Query!
Country [154]
0
0
Czechia
Query!
State/province [154]
0
0
Kromeriz
Query!
Country [155]
0
0
Czechia
Query!
State/province [155]
0
0
Litovel
Query!
Country [156]
0
0
Czechia
Query!
State/province [156]
0
0
Olomouc
Query!
Country [157]
0
0
Czechia
Query!
State/province [157]
0
0
Ostrava Poruba
Query!
Country [158]
0
0
Czechia
Query!
State/province [158]
0
0
Pardubice
Query!
Country [159]
0
0
Czechia
Query!
State/province [159]
0
0
Plzen
Query!
Country [160]
0
0
Czechia
Query!
State/province [160]
0
0
Prague
Query!
Country [161]
0
0
Czechia
Query!
State/province [161]
0
0
Praha 10
Query!
Country [162]
0
0
Czechia
Query!
State/province [162]
0
0
Praha 1
Query!
Country [163]
0
0
Czechia
Query!
State/province [163]
0
0
Praha
Query!
Country [164]
0
0
Czechia
Query!
State/province [164]
0
0
Pribram
Query!
Country [165]
0
0
Czechia
Query!
State/province [165]
0
0
Slany
Query!
Country [166]
0
0
Czechia
Query!
State/province [166]
0
0
Trutnov
Query!
Country [167]
0
0
Czechia
Query!
State/province [167]
0
0
Uherske Hradiste
Query!
Country [168]
0
0
Czechia
Query!
State/province [168]
0
0
Zlin
Query!
Country [169]
0
0
Denmark
Query!
State/province [169]
0
0
Aarhus
Query!
Country [170]
0
0
Denmark
Query!
State/province [170]
0
0
Copenhagen S
Query!
Country [171]
0
0
Denmark
Query!
State/province [171]
0
0
Herlev
Query!
Country [172]
0
0
Denmark
Query!
State/province [172]
0
0
Herning
Query!
Country [173]
0
0
Denmark
Query!
State/province [173]
0
0
Holbæk
Query!
Country [174]
0
0
Denmark
Query!
State/province [174]
0
0
Hvidovre
Query!
Country [175]
0
0
Denmark
Query!
State/province [175]
0
0
Køge
Query!
Country [176]
0
0
Denmark
Query!
State/province [176]
0
0
Slagelse
Query!
Country [177]
0
0
Denmark
Query!
State/province [177]
0
0
Svendborg
Query!
Country [178]
0
0
Estonia
Query!
State/province [178]
0
0
Tallinn
Query!
Country [179]
0
0
France
Query!
State/province [179]
0
0
Angers Cedex 9
Query!
Country [180]
0
0
France
Query!
State/province [180]
0
0
Bayonne Cedex
Query!
Country [181]
0
0
France
Query!
State/province [181]
0
0
Beziers cedex
Query!
Country [182]
0
0
France
Query!
State/province [182]
0
0
Bron cedex
Query!
Country [183]
0
0
France
Query!
State/province [183]
0
0
Corbeil Essonnes cedex
Query!
Country [184]
0
0
France
Query!
State/province [184]
0
0
Creteil
Query!
Country [185]
0
0
France
Query!
State/province [185]
0
0
Limoges cedex
Query!
Country [186]
0
0
France
Query!
State/province [186]
0
0
Montauban
Query!
Country [187]
0
0
France
Query!
State/province [187]
0
0
Nice Cedex 1
Query!
Country [188]
0
0
France
Query!
State/province [188]
0
0
Paris Cedex 12
Query!
Country [189]
0
0
France
Query!
State/province [189]
0
0
Paris
Query!
Country [190]
0
0
France
Query!
State/province [190]
0
0
Poitiers
Query!
Country [191]
0
0
France
Query!
State/province [191]
0
0
Rouen
Query!
Country [192]
0
0
France
Query!
State/province [192]
0
0
Valenciennes
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Altenburg
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Bad Friedrichshall
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Bad Homburg
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Bamberg
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Berlin
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Bielefeld
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Bonn-Beuel
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Dachau
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Deggingen
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Dessau-Rosslau
Query!
Country [203]
0
0
Germany
Query!
State/province [203]
0
0
Dresden
Query!
Country [204]
0
0
Germany
Query!
State/province [204]
0
0
Elsterwerda
Query!
Country [205]
0
0
Germany
Query!
State/province [205]
0
0
Essen
Query!
Country [206]
0
0
Germany
Query!
State/province [206]
0
0
Frankfurt
Query!
Country [207]
0
0
Germany
Query!
State/province [207]
0
0
Freiburg
Query!
Country [208]
0
0
Germany
Query!
State/province [208]
0
0
Hamburg
Query!
Country [209]
0
0
Germany
Query!
State/province [209]
0
0
Kiel
Query!
Country [210]
0
0
Germany
Query!
State/province [210]
0
0
Ludwigshafen, Rp
Query!
Country [211]
0
0
Germany
Query!
State/province [211]
0
0
Mainz
Query!
Country [212]
0
0
Germany
Query!
State/province [212]
0
0
Mannheim
Query!
Country [213]
0
0
Germany
Query!
State/province [213]
0
0
Neuwied
Query!
Country [214]
0
0
Germany
Query!
State/province [214]
0
0
Nuremberg
Query!
Country [215]
0
0
Germany
Query!
State/province [215]
0
0
Papenburg
Query!
Country [216]
0
0
Germany
Query!
State/province [216]
0
0
Stuhr
Query!
Country [217]
0
0
Germany
Query!
State/province [217]
0
0
Wermsdorf
Query!
Country [218]
0
0
Germany
Query!
State/province [218]
0
0
Worms
Query!
Country [219]
0
0
Greece
Query!
State/province [219]
0
0
Alexandroupolis
Query!
Country [220]
0
0
Hungary
Query!
State/province [220]
0
0
Baja
Query!
Country [221]
0
0
Hungary
Query!
State/province [221]
0
0
Balatonfured
Query!
Country [222]
0
0
Hungary
Query!
State/province [222]
0
0
Bekescsaba
Query!
Country [223]
0
0
Hungary
Query!
State/province [223]
0
0
Budapest
Query!
Country [224]
0
0
Hungary
Query!
State/province [224]
0
0
Debrecen
Query!
Country [225]
0
0
Hungary
Query!
State/province [225]
0
0
Gyongyos
Query!
Country [226]
0
0
Hungary
Query!
State/province [226]
0
0
Hatvan
Query!
Country [227]
0
0
Hungary
Query!
State/province [227]
0
0
Hodmezovasarhely
Query!
Country [228]
0
0
Hungary
Query!
State/province [228]
0
0
Kaposvar
Query!
Country [229]
0
0
Hungary
Query!
State/province [229]
0
0
Kecskemet
Query!
Country [230]
0
0
Hungary
Query!
State/province [230]
0
0
Miskolc
Query!
Country [231]
0
0
Hungary
Query!
State/province [231]
0
0
Mosonmagyarovar
Query!
Country [232]
0
0
Hungary
Query!
State/province [232]
0
0
Nyiregyhaza
Query!
Country [233]
0
0
Hungary
Query!
State/province [233]
0
0
Oroshaza
Query!
Country [234]
0
0
Hungary
Query!
State/province [234]
0
0
Pecs
Query!
Country [235]
0
0
Hungary
Query!
State/province [235]
0
0
Szeged
Query!
Country [236]
0
0
Hungary
Query!
State/province [236]
0
0
Szekesfehervar
Query!
Country [237]
0
0
Hungary
Query!
State/province [237]
0
0
Szolnok
Query!
Country [238]
0
0
Hungary
Query!
State/province [238]
0
0
Zalaegerszeg
Query!
Country [239]
0
0
Israel
Query!
State/province [239]
0
0
Afula
Query!
Country [240]
0
0
Israel
Query!
State/province [240]
0
0
Hadera
Query!
Country [241]
0
0
Israel
Query!
State/province [241]
0
0
Haifa
Query!
Country [242]
0
0
Israel
Query!
State/province [242]
0
0
Holon
Query!
Country [243]
0
0
Israel
Query!
State/province [243]
0
0
Jerusalem
Query!
Country [244]
0
0
Israel
Query!
State/province [244]
0
0
Kfar-Sava
Query!
Country [245]
0
0
Israel
Query!
State/province [245]
0
0
Nazareth
Query!
Country [246]
0
0
Israel
Query!
State/province [246]
0
0
Petah Tikva
Query!
Country [247]
0
0
Israel
Query!
State/province [247]
0
0
Ramat Gan
Query!
Country [248]
0
0
Israel
Query!
State/province [248]
0
0
Rechovot
Query!
Country [249]
0
0
Israel
Query!
State/province [249]
0
0
Rishon Lezion
Query!
Country [250]
0
0
Israel
Query!
State/province [250]
0
0
Safed
Query!
Country [251]
0
0
Israel
Query!
State/province [251]
0
0
Yerushalayim
Query!
Country [252]
0
0
Italy
Query!
State/province [252]
0
0
Arezzo
Query!
Country [253]
0
0
Italy
Query!
State/province [253]
0
0
Aversa
Query!
Country [254]
0
0
Italy
Query!
State/province [254]
0
0
Bergamo
Query!
Country [255]
0
0
Italy
Query!
State/province [255]
0
0
Bologna
Query!
Country [256]
0
0
Italy
Query!
State/province [256]
0
0
Caserta
Query!
Country [257]
0
0
Italy
Query!
State/province [257]
0
0
Catania
Query!
Country [258]
0
0
Italy
Query!
State/province [258]
0
0
Catanzaro
Query!
Country [259]
0
0
Italy
Query!
State/province [259]
0
0
Ferrara
Query!
Country [260]
0
0
Italy
Query!
State/province [260]
0
0
Lecco
Query!
Country [261]
0
0
Italy
Query!
State/province [261]
0
0
Massa
Query!
Country [262]
0
0
Italy
Query!
State/province [262]
0
0
Milano
Query!
Country [263]
0
0
Italy
Query!
State/province [263]
0
0
Monza
Query!
Country [264]
0
0
Italy
Query!
State/province [264]
0
0
Pavia
Query!
Country [265]
0
0
Italy
Query!
State/province [265]
0
0
Pisa
Query!
Country [266]
0
0
Italy
Query!
State/province [266]
0
0
Roma
Query!
Country [267]
0
0
Italy
Query!
State/province [267]
0
0
Rozzano
Query!
Country [268]
0
0
Italy
Query!
State/province [268]
0
0
Sassari
Query!
Country [269]
0
0
Italy
Query!
State/province [269]
0
0
Torino
Query!
Country [270]
0
0
Italy
Query!
State/province [270]
0
0
Torrette Di Ancona
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Aichi
Query!
Country [272]
0
0
Japan
Query!
State/province [272]
0
0
Bunkyo Ku
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Chiba
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Chikushino-shi
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Fukuoka
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Funabashi-shi
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Gifu
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Higashiibaraki-gun
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Hirosaki-shi
Query!
Country [280]
0
0
Japan
Query!
State/province [280]
0
0
Hiroshima shi
Query!
Country [281]
0
0
Japan
Query!
State/province [281]
0
0
Hiroshima-shi
Query!
Country [282]
0
0
Japan
Query!
State/province [282]
0
0
Hokkaido
Query!
Country [283]
0
0
Japan
Query!
State/province [283]
0
0
Hyogo
Query!
Country [284]
0
0
Japan
Query!
State/province [284]
0
0
Isehara
Query!
Country [285]
0
0
Japan
Query!
State/province [285]
0
0
Ishikawa
Query!
Country [286]
0
0
Japan
Query!
State/province [286]
0
0
Itabashi Ku
Query!
Country [287]
0
0
Japan
Query!
State/province [287]
0
0
Kagoshima-shi
Query!
Country [288]
0
0
Japan
Query!
State/province [288]
0
0
Kasuga-shi
Query!
Country [289]
0
0
Japan
Query!
State/province [289]
0
0
Kawasaki-shi
Query!
Country [290]
0
0
Japan
Query!
State/province [290]
0
0
Kitakyushu-shi
Query!
Country [291]
0
0
Japan
Query!
State/province [291]
0
0
Kumamoto-shi
Query!
Country [292]
0
0
Japan
Query!
State/province [292]
0
0
Kumamoto
Query!
Country [293]
0
0
Japan
Query!
State/province [293]
0
0
Kusatsu-shi
Query!
Country [294]
0
0
Japan
Query!
State/province [294]
0
0
Kyoto-shi
Query!
Country [295]
0
0
Japan
Query!
State/province [295]
0
0
Matsuyama-shi
Query!
Country [296]
0
0
Japan
Query!
State/province [296]
0
0
Mito-shi
Query!
Country [297]
0
0
Japan
Query!
State/province [297]
0
0
Miyazaki-shi
Query!
Country [298]
0
0
Japan
Query!
State/province [298]
0
0
Miyazaki
Query!
Country [299]
0
0
Japan
Query!
State/province [299]
0
0
Nagoya-shi
Query!
Country [300]
0
0
Japan
Query!
State/province [300]
0
0
Narashino-shi
Query!
Country [301]
0
0
Japan
Query!
State/province [301]
0
0
Nishinomiya-shi
Query!
Country [302]
0
0
Japan
Query!
State/province [302]
0
0
Nishitokyo-shi
Query!
Country [303]
0
0
Japan
Query!
State/province [303]
0
0
Okayama-shi
Query!
Country [304]
0
0
Japan
Query!
State/province [304]
0
0
Okinawa
Query!
Country [305]
0
0
Japan
Query!
State/province [305]
0
0
Osaka Sayama shi
Query!
Country [306]
0
0
Japan
Query!
State/province [306]
0
0
Osaka-shi
Query!
Country [307]
0
0
Japan
Query!
State/province [307]
0
0
Osaka
Query!
Country [308]
0
0
Japan
Query!
State/province [308]
0
0
Sagamihara
Query!
Country [309]
0
0
Japan
Query!
State/province [309]
0
0
Saitama-shi
Query!
Country [310]
0
0
Japan
Query!
State/province [310]
0
0
Sapporo-shi
Query!
Country [311]
0
0
Japan
Query!
State/province [311]
0
0
Sendai shi
Query!
Country [312]
0
0
Japan
Query!
State/province [312]
0
0
Shinagawa
Query!
Country [313]
0
0
Japan
Query!
State/province [313]
0
0
Shinjuku-ku
Query!
Country [314]
0
0
Japan
Query!
State/province [314]
0
0
Suita-Shi
Query!
Country [315]
0
0
Japan
Query!
State/province [315]
0
0
Takatsuki-shi
Query!
Country [316]
0
0
Japan
Query!
State/province [316]
0
0
Tokyo
Query!
Country [317]
0
0
Japan
Query!
State/province [317]
0
0
Tomakomai
Query!
Country [318]
0
0
Japan
Query!
State/province [318]
0
0
Toyoake
Query!
Country [319]
0
0
Japan
Query!
State/province [319]
0
0
Uwajima-shi
Query!
Country [320]
0
0
Japan
Query!
State/province [320]
0
0
Yokohama
Query!
Country [321]
0
0
Japan
Query!
State/province [321]
0
0
Yufu
Query!
Country [322]
0
0
Korea, Republic of
Query!
State/province [322]
0
0
Anyang-si
Query!
Country [323]
0
0
Korea, Republic of
Query!
State/province [323]
0
0
Busan
Query!
Country [324]
0
0
Korea, Republic of
Query!
State/province [324]
0
0
Cheongju-si
Query!
Country [325]
0
0
Korea, Republic of
Query!
State/province [325]
0
0
Chuncheon
Query!
Country [326]
0
0
Korea, Republic of
Query!
State/province [326]
0
0
Daegu
Query!
Country [327]
0
0
Korea, Republic of
Query!
State/province [327]
0
0
Daejeon
Query!
Country [328]
0
0
Korea, Republic of
Query!
State/province [328]
0
0
Goyang-si
Query!
Country [329]
0
0
Korea, Republic of
Query!
State/province [329]
0
0
Guri-Si
Query!
Country [330]
0
0
Korea, Republic of
Query!
State/province [330]
0
0
Gwangju
Query!
Country [331]
0
0
Korea, Republic of
Query!
State/province [331]
0
0
Gyeonggi-do
Query!
Country [332]
0
0
Korea, Republic of
Query!
State/province [332]
0
0
Incheon
Query!
Country [333]
0
0
Korea, Republic of
Query!
State/province [333]
0
0
Seongnam
Query!
Country [334]
0
0
Korea, Republic of
Query!
State/province [334]
0
0
Seoul
Query!
Country [335]
0
0
Korea, Republic of
Query!
State/province [335]
0
0
Suwon
Query!
Country [336]
0
0
Korea, Republic of
Query!
State/province [336]
0
0
Wonju
Query!
Country [337]
0
0
Korea, Republic of
Query!
State/province [337]
0
0
Yongin si
Query!
Country [338]
0
0
Latvia
Query!
State/province [338]
0
0
Daugavpils
Query!
Country [339]
0
0
Latvia
Query!
State/province [339]
0
0
Riga
Query!
Country [340]
0
0
Lithuania
Query!
State/province [340]
0
0
Kaunas
Query!
Country [341]
0
0
Lithuania
Query!
State/province [341]
0
0
Klaipeda
Query!
Country [342]
0
0
Lithuania
Query!
State/province [342]
0
0
Vilnius
Query!
Country [343]
0
0
Malaysia
Query!
State/province [343]
0
0
Alor Setar
Query!
Country [344]
0
0
Malaysia
Query!
State/province [344]
0
0
Kota Kinabalu
Query!
Country [345]
0
0
Malaysia
Query!
State/province [345]
0
0
Kuala Lumpur
Query!
Country [346]
0
0
Malaysia
Query!
State/province [346]
0
0
Seri Manjung
Query!
Country [347]
0
0
Malaysia
Query!
State/province [347]
0
0
Taiping
Query!
Country [348]
0
0
Netherlands
Query!
State/province [348]
0
0
Alkmaar
Query!
Country [349]
0
0
Netherlands
Query!
State/province [349]
0
0
Almelo
Query!
Country [350]
0
0
Netherlands
Query!
State/province [350]
0
0
Amersfoort
Query!
Country [351]
0
0
Netherlands
Query!
State/province [351]
0
0
Amsterdam
Query!
Country [352]
0
0
Netherlands
Query!
State/province [352]
0
0
Delft
Query!
Country [353]
0
0
Netherlands
Query!
State/province [353]
0
0
Deventer
Query!
Country [354]
0
0
Netherlands
Query!
State/province [354]
0
0
Doetinchem
Query!
Country [355]
0
0
Netherlands
Query!
State/province [355]
0
0
Ede
Query!
Country [356]
0
0
Netherlands
Query!
State/province [356]
0
0
Eindhoven
Query!
Country [357]
0
0
Netherlands
Query!
State/province [357]
0
0
Gouda
Query!
Country [358]
0
0
Netherlands
Query!
State/province [358]
0
0
Heerlen
Query!
Country [359]
0
0
Netherlands
Query!
State/province [359]
0
0
Helmond
Query!
Country [360]
0
0
Netherlands
Query!
State/province [360]
0
0
Leiderdorp
Query!
Country [361]
0
0
Netherlands
Query!
State/province [361]
0
0
Nieuwegein
Query!
Country [362]
0
0
Netherlands
Query!
State/province [362]
0
0
Nijmegen
Query!
Country [363]
0
0
Netherlands
Query!
State/province [363]
0
0
Rotterdam
Query!
Country [364]
0
0
Netherlands
Query!
State/province [364]
0
0
s-Hertogenbosch
Query!
Country [365]
0
0
Netherlands
Query!
State/province [365]
0
0
Sneek
Query!
Country [366]
0
0
Netherlands
Query!
State/province [366]
0
0
Tilburg
Query!
Country [367]
0
0
Netherlands
Query!
State/province [367]
0
0
Veldhoven
Query!
Country [368]
0
0
Netherlands
Query!
State/province [368]
0
0
Zutphen
Query!
Country [369]
0
0
New Zealand
Query!
State/province [369]
0
0
Auckland
Query!
Country [370]
0
0
New Zealand
Query!
State/province [370]
0
0
Christchurch
Query!
Country [371]
0
0
New Zealand
Query!
State/province [371]
0
0
Dunedin
Query!
Country [372]
0
0
New Zealand
Query!
State/province [372]
0
0
Hamilton
Query!
Country [373]
0
0
New Zealand
Query!
State/province [373]
0
0
Hastings
Query!
Country [374]
0
0
New Zealand
Query!
State/province [374]
0
0
New Plymouth
Query!
Country [375]
0
0
New Zealand
Query!
State/province [375]
0
0
Rotorua
Query!
Country [376]
0
0
New Zealand
Query!
State/province [376]
0
0
Tauranga
Query!
Country [377]
0
0
Poland
Query!
State/province [377]
0
0
Bydgoszcz
Query!
Country [378]
0
0
Poland
Query!
State/province [378]
0
0
Chojnice
Query!
Country [379]
0
0
Poland
Query!
State/province [379]
0
0
Chorzow
Query!
Country [380]
0
0
Poland
Query!
State/province [380]
0
0
Chrzanow
Query!
Country [381]
0
0
Poland
Query!
State/province [381]
0
0
Elblag
Query!
Country [382]
0
0
Poland
Query!
State/province [382]
0
0
Gdansk
Query!
Country [383]
0
0
Poland
Query!
State/province [383]
0
0
Gdynia
Query!
Country [384]
0
0
Poland
Query!
State/province [384]
0
0
Grodzisk Mazowiecki
Query!
Country [385]
0
0
Poland
Query!
State/province [385]
0
0
Jelenia Góra
Query!
Country [386]
0
0
Poland
Query!
State/province [386]
0
0
Katowice
Query!
Country [387]
0
0
Poland
Query!
State/province [387]
0
0
Kielce
Query!
Country [388]
0
0
Poland
Query!
State/province [388]
0
0
Krakow
Query!
Country [389]
0
0
Poland
Query!
State/province [389]
0
0
Legnica
Query!
Country [390]
0
0
Poland
Query!
State/province [390]
0
0
Lodz
Query!
Country [391]
0
0
Poland
Query!
State/province [391]
0
0
Lowicz
Query!
Country [392]
0
0
Poland
Query!
State/province [392]
0
0
Lublin
Query!
Country [393]
0
0
Poland
Query!
State/province [393]
0
0
Olsztyn
Query!
Country [394]
0
0
Poland
Query!
State/province [394]
0
0
Ostrowiec Swietokrzyski
Query!
Country [395]
0
0
Poland
Query!
State/province [395]
0
0
Oswiecim
Query!
Country [396]
0
0
Poland
Query!
State/province [396]
0
0
Piaseczno
Query!
Country [397]
0
0
Poland
Query!
State/province [397]
0
0
Poznan
Query!
Country [398]
0
0
Poland
Query!
State/province [398]
0
0
Przemysl
Query!
Country [399]
0
0
Poland
Query!
State/province [399]
0
0
Ruda Slaska
Query!
Country [400]
0
0
Poland
Query!
State/province [400]
0
0
Rzeszow
Query!
Country [401]
0
0
Poland
Query!
State/province [401]
0
0
Siedlce
Query!
Country [402]
0
0
Poland
Query!
State/province [402]
0
0
Skierniewice
Query!
Country [403]
0
0
Poland
Query!
State/province [403]
0
0
Warsaw
Query!
Country [404]
0
0
Poland
Query!
State/province [404]
0
0
Warszawa
Query!
Country [405]
0
0
Poland
Query!
State/province [405]
0
0
Wroclaw
Query!
Country [406]
0
0
Poland
Query!
State/province [406]
0
0
Zamosc
Query!
Country [407]
0
0
Portugal
Query!
State/province [407]
0
0
Covilha
Query!
Country [408]
0
0
Portugal
Query!
State/province [408]
0
0
Figueira da Foz
Query!
Country [409]
0
0
Portugal
Query!
State/province [409]
0
0
Lisboa
Query!
Country [410]
0
0
Portugal
Query!
State/province [410]
0
0
Santa Maria da Feira
Query!
Country [411]
0
0
Portugal
Query!
State/province [411]
0
0
Torres Novas
Query!
Country [412]
0
0
Portugal
Query!
State/province [412]
0
0
Vila Nova de Gaia
Query!
Country [413]
0
0
Portugal
Query!
State/province [413]
0
0
Vila Real
Query!
Country [414]
0
0
Romania
Query!
State/province [414]
0
0
Baia Mare
Query!
Country [415]
0
0
Romania
Query!
State/province [415]
0
0
Braila
Query!
Country [416]
0
0
Romania
Query!
State/province [416]
0
0
Brasov
Query!
Country [417]
0
0
Romania
Query!
State/province [417]
0
0
Bucharest
Query!
Country [418]
0
0
Romania
Query!
State/province [418]
0
0
Bucuresti
Query!
Country [419]
0
0
Romania
Query!
State/province [419]
0
0
Cluj-Napoca
Query!
Country [420]
0
0
Romania
Query!
State/province [420]
0
0
Iasi
Query!
Country [421]
0
0
Romania
Query!
State/province [421]
0
0
Oradea
Query!
Country [422]
0
0
Romania
Query!
State/province [422]
0
0
Pitesti
Query!
Country [423]
0
0
Romania
Query!
State/province [423]
0
0
Sibiu
Query!
Country [424]
0
0
Romania
Query!
State/province [424]
0
0
Suceava
Query!
Country [425]
0
0
Romania
Query!
State/province [425]
0
0
Targu Mures
Query!
Country [426]
0
0
Romania
Query!
State/province [426]
0
0
Tg. Mures
Query!
Country [427]
0
0
Romania
Query!
State/province [427]
0
0
Timisoara
Query!
Country [428]
0
0
Serbia
Query!
State/province [428]
0
0
Belgrade
Query!
Country [429]
0
0
Serbia
Query!
State/province [429]
0
0
Kragujevac
Query!
Country [430]
0
0
Serbia
Query!
State/province [430]
0
0
Niska Banja
Query!
Country [431]
0
0
Serbia
Query!
State/province [431]
0
0
Nis
Query!
Country [432]
0
0
Serbia
Query!
State/province [432]
0
0
Pancevo
Query!
Country [433]
0
0
Serbia
Query!
State/province [433]
0
0
Smederevo
Query!
Country [434]
0
0
Serbia
Query!
State/province [434]
0
0
Sremska Mitrovica
Query!
Country [435]
0
0
Serbia
Query!
State/province [435]
0
0
Zajecar
Query!
Country [436]
0
0
Slovakia
Query!
State/province [436]
0
0
Bardejov
Query!
Country [437]
0
0
Slovakia
Query!
State/province [437]
0
0
Bratislava
Query!
Country [438]
0
0
Slovakia
Query!
State/province [438]
0
0
Brezno
Query!
Country [439]
0
0
Slovakia
Query!
State/province [439]
0
0
Dolny Kubin
Query!
Country [440]
0
0
Slovakia
Query!
State/province [440]
0
0
Kosice
Query!
Country [441]
0
0
Slovakia
Query!
State/province [441]
0
0
Košice
Query!
Country [442]
0
0
Slovakia
Query!
State/province [442]
0
0
Lucenec
Query!
Country [443]
0
0
Slovakia
Query!
State/province [443]
0
0
Moldava nad Bodvou
Query!
Country [444]
0
0
Slovakia
Query!
State/province [444]
0
0
Nitra
Query!
Country [445]
0
0
Slovakia
Query!
State/province [445]
0
0
Nove Zamky
Query!
Country [446]
0
0
Slovakia
Query!
State/province [446]
0
0
Presov
Query!
Country [447]
0
0
Slovakia
Query!
State/province [447]
0
0
Prešov
Query!
Country [448]
0
0
Slovakia
Query!
State/province [448]
0
0
Svidnik
Query!
Country [449]
0
0
Slovakia
Query!
State/province [449]
0
0
Zilina
Query!
Country [450]
0
0
South Africa
Query!
State/province [450]
0
0
Cape Town
Query!
Country [451]
0
0
South Africa
Query!
State/province [451]
0
0
Centurion
Query!
Country [452]
0
0
South Africa
Query!
State/province [452]
0
0
Johannesburg
Query!
Country [453]
0
0
South Africa
Query!
State/province [453]
0
0
Krugersdorp
Query!
Country [454]
0
0
South Africa
Query!
State/province [454]
0
0
Pretoria
Query!
Country [455]
0
0
South Africa
Query!
State/province [455]
0
0
Somerset West
Query!
Country [456]
0
0
South Africa
Query!
State/province [456]
0
0
Tongaat
Query!
Country [457]
0
0
South Africa
Query!
State/province [457]
0
0
Worcester
Query!
Country [458]
0
0
Spain
Query!
State/province [458]
0
0
A Coruña
Query!
Country [459]
0
0
Spain
Query!
State/province [459]
0
0
Alicante
Query!
Country [460]
0
0
Spain
Query!
State/province [460]
0
0
Barcelona
Query!
Country [461]
0
0
Spain
Query!
State/province [461]
0
0
El Palmar
Query!
Country [462]
0
0
Spain
Query!
State/province [462]
0
0
Lleida
Query!
Country [463]
0
0
Spain
Query!
State/province [463]
0
0
Madrid
Query!
Country [464]
0
0
Spain
Query!
State/province [464]
0
0
Malaga
Query!
Country [465]
0
0
Spain
Query!
State/province [465]
0
0
Manises
Query!
Country [466]
0
0
Spain
Query!
State/province [466]
0
0
Santiago de Compostela
Query!
Country [467]
0
0
Spain
Query!
State/province [467]
0
0
Valencia
Query!
Country [468]
0
0
Taiwan
Query!
State/province [468]
0
0
Changhua
Query!
Country [469]
0
0
Taiwan
Query!
State/province [469]
0
0
Kaohsiung
Query!
Country [470]
0
0
Taiwan
Query!
State/province [470]
0
0
New Taipei
Query!
Country [471]
0
0
Taiwan
Query!
State/province [471]
0
0
Taichung
Query!
Country [472]
0
0
Taiwan
Query!
State/province [472]
0
0
Taipei City
Query!
Country [473]
0
0
Taiwan
Query!
State/province [473]
0
0
Taipei
Query!
Country [474]
0
0
Taiwan
Query!
State/province [474]
0
0
Taoyuan County
Query!
Country [475]
0
0
United Kingdom
Query!
State/province [475]
0
0
Bristol
Query!
Country [476]
0
0
United Kingdom
Query!
State/province [476]
0
0
Clydebank
Query!
Country [477]
0
0
United Kingdom
Query!
State/province [477]
0
0
Dorchester
Query!
Country [478]
0
0
United Kingdom
Query!
State/province [478]
0
0
High Wycombe
Query!
Country [479]
0
0
United Kingdom
Query!
State/province [479]
0
0
Lincoln
Query!
Country [480]
0
0
United Kingdom
Query!
State/province [480]
0
0
London
Query!
Country [481]
0
0
United Kingdom
Query!
State/province [481]
0
0
Sheffield
Query!
Country [482]
0
0
United Kingdom
Query!
State/province [482]
0
0
Truro
Query!
Country [483]
0
0
United Kingdom
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State/province [483]
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Wigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Bristol-Myers Squibb
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.
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Trial website
https://clinicaltrials.gov/study/NCT05757869
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Contact person for public queries
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Study Contact
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Phone
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844-434-4210
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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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.
Results not provided in
https://clinicaltrials.gov/study/NCT05757869