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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05686070
Registration number
NCT05686070
Ethics application status
Date submitted
6/01/2023
Date registered
17/01/2023
Titles & IDs
Public title
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke
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Scientific title
A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA
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Secondary ID [1]
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0
2023-503793-20-00
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Secondary ID [2]
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20604
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Universal Trial Number (UTN)
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Trial acronym
OCEANIC-STROKE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prevention of Ischemic Stroke
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Acute Non-cardioembolic Ischemic Stroke
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High-risk Transient Ischemic Attack
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Condition category
Condition code
Stroke
0
0
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Haemorrhagic
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Stroke
0
0
0
0
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Ischaemic
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Neurological
0
0
0
0
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Other neurological disorders
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Asundexian (BAY2433334)
Treatment: Drugs - Placebo
Experimental: Asundexian - Participants will receive asundexian.
Placebo comparator: Placebo - Participants will receive placebo.
Treatment: Drugs: Asundexian (BAY2433334)
Once daily, oral
Treatment: Drugs: Placebo
Placebo to asundexian, once daily, oral
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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 first occurrence of ischemic stroke
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Assessment method [1]
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0
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Timepoint [1]
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Up to 31 months
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Primary outcome [2]
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Time to first occurrence of ISTH major bleeding
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Assessment method [2]
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ISTH=International Society on Thrombosis and Hemostasis
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Timepoint [2]
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Up to 31 months
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Secondary outcome [1]
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Time to first occurrence of all strokes (ischemic and hemorrhagic)
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Assessment method [1]
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0
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Timepoint [1]
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Up to 31 months
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Secondary outcome [2]
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Time to first occurrence of composite of CV death, MI or stroke
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Assessment method [2]
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CV=Cardiovascular, MI=Myocardial infarction
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Timepoint [2]
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Up to 31 months
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Secondary outcome [3]
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Time to first occurrence of composite of all-cause mortality, MI or stroke
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Assessment method [3]
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Timepoint [3]
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Up to 31 months
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Secondary outcome [4]
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Time to first occurrence of disabling stroke (mRS =3 at 90 days)
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Assessment method [4]
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mRS=Modified Rankin Scale
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Timepoint [4]
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Up to 31 months
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Secondary outcome [5]
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Time to first occurrence of all-cause mortality
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Assessment method [5]
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0
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Timepoint [5]
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Up to 31 months
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Secondary outcome [6]
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Time to first occurrence of transient ischemic attack (TIA)
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Assessment method [6]
0
0
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Timepoint [6]
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Up to 31 months
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Secondary outcome [7]
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Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
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Assessment method [7]
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0
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Timepoint [7]
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Up to 31 months
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Secondary outcome [8]
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Time to first occurrence of ISTH clinically relevant non-major bleeding
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Assessment method [8]
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0
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Timepoint [8]
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Up to 31 months
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Secondary outcome [9]
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Time to first occurrence of symptomatic intracranial hemorrhage
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Assessment method [9]
0
0
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Timepoint [9]
0
0
Up to 31 months
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Secondary outcome [10]
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0
Time to first occurrence of hemorrhagic stroke
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Up to 31 months
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Secondary outcome [11]
0
0
Time to first occurrence of fatal bleeding
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Up to 31 months
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Secondary outcome [12]
0
0
Time to first occurrence of minor bleeding
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Up to 31 months
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Secondary outcome [13]
0
0
Time to first occurrence of composite of ischemic stroke or ISTH major bleeding
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Assessment method [13]
0
0
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Timepoint [13]
0
0
Up to 31 months
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Secondary outcome [14]
0
0
Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding
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Assessment method [14]
0
0
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Timepoint [14]
0
0
Up to 31 months
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Secondary outcome [15]
0
0
Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage
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Assessment method [15]
0
0
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Timepoint [15]
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Up to 31 months
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Secondary outcome [16]
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Time to first occurrence of ischemic stroke in the first 90 days
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Assessment method [16]
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Timepoint [16]
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Up to 31 months
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Eligibility
Key inclusion criteria
* Participants must be = 18 years of age
* Acute non-cardioembolic stroke or high-risk TIA
* Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
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Minimum age
18
Years
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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
* Ischemic stroke = 7 days before the index event
* Index stroke following procedures or strokes due to other rare causes
* History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring 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 administering the treatment/s
The people assessing the outcomes
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
26/01/2023
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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
10/10/2025
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Actual
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Sample size
Target
12300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Blacktown Hospital - Blacktownn
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Recruitment hospital [3]
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South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department - Liverpool
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Recruitment hospital [4]
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John Hunter Hospital - New Lambton
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Recruitment hospital [5]
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Royal Prince Alfred Hospital - Newtown
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Recruitment hospital [6]
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Prince of Wales Hospital NSW - Randwick
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Recruitment hospital [7]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [8]
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Nepean Hospital - Sydney
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Recruitment hospital [9]
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Westmead Hospital - Westmead
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Recruitment hospital [10]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [11]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [12]
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Princess Alexandra Hospital Australia - Brisbane
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Recruitment hospital [13]
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Redcliffe District Hospital - Redcliffe
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Recruitment hospital [14]
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Gold Coast University Hospital - Southport
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Recruitment hospital [15]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [16]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [17]
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Launceston General Hospital - Launceston
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Recruitment hospital [18]
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Grampians Health Ballarat - Ballarat
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Recruitment hospital [19]
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Eastern Health Box Hill Hospital - Box Hill
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Recruitment hospital [20]
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Monash Medical Centre - Clayton
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Recruitment hospital [21]
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The Alfred Hospital - Melbourne
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Recruitment hospital [22]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [23]
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Western Health Neuroscience Research Unit - St Albans
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Recruitment hospital [24]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [25]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2148 - Blacktownn
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2305 - New Lambton
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Recruitment postcode(s) [5]
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2042 - Newtown
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Recruitment postcode(s) [6]
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2031 - Randwick
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Recruitment postcode(s) [7]
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2065 - St Leonards
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Recruitment postcode(s) [8]
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2751 - Sydney
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment postcode(s) [10]
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4575 - Birtinya
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Recruitment postcode(s) [11]
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4029 - Brisbane
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Recruitment postcode(s) [12]
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4102 - Brisbane
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Recruitment postcode(s) [13]
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4020 - Redcliffe
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Recruitment postcode(s) [14]
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4215 - Southport
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Recruitment postcode(s) [15]
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5000 - Adelaide
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Recruitment postcode(s) [16]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [17]
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7250 - Launceston
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Recruitment postcode(s) [18]
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3350 - Ballarat
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Recruitment postcode(s) [19]
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3128 - Box Hill
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Recruitment postcode(s) [20]
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3168 - Clayton
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Recruitment postcode(s) [21]
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3004 - Melbourne
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Recruitment postcode(s) [22]
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3050 - Parkville
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Recruitment postcode(s) [23]
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3021 - St Albans
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Recruitment postcode(s) [24]
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6961 - Murdoch
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Recruitment postcode(s) [25]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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Arizona
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Connecticut
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Delaware
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Florida
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Illinois
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Louisiana
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Maryland
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Ciudad Auton. De Buenos Aires
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Rio de Janeiro
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Plovdiv
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Varna
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Canada
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Alberta
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Canada
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China
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China
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0
0
China
Query!
State/province [87]
0
0
Guangxi
Query!
Country [88]
0
0
China
Query!
State/province [88]
0
0
Hainan
Query!
Country [89]
0
0
China
Query!
State/province [89]
0
0
Hebei
Query!
Country [90]
0
0
China
Query!
State/province [90]
0
0
Heilongjiang
Query!
Country [91]
0
0
China
Query!
State/province [91]
0
0
Henan
Query!
Country [92]
0
0
China
Query!
State/province [92]
0
0
Hubei
Query!
Country [93]
0
0
China
Query!
State/province [93]
0
0
Hunan
Query!
Country [94]
0
0
China
Query!
State/province [94]
0
0
Inner Mongolia
Query!
Country [95]
0
0
China
Query!
State/province [95]
0
0
Jiangsu
Query!
Country [96]
0
0
China
Query!
State/province [96]
0
0
Jiangxi
Query!
Country [97]
0
0
China
Query!
State/province [97]
0
0
Jilin
Query!
Country [98]
0
0
China
Query!
State/province [98]
0
0
Liaoning
Query!
Country [99]
0
0
China
Query!
State/province [99]
0
0
Ningxia
Query!
Country [100]
0
0
China
Query!
State/province [100]
0
0
Qinghai
Query!
Country [101]
0
0
China
Query!
State/province [101]
0
0
Shaanxi
Query!
Country [102]
0
0
China
Query!
State/province [102]
0
0
Shandong
Query!
Country [103]
0
0
China
Query!
State/province [103]
0
0
Shanxi
Query!
Country [104]
0
0
China
Query!
State/province [104]
0
0
Sichuan
Query!
Country [105]
0
0
China
Query!
State/province [105]
0
0
Zhejiang
Query!
Country [106]
0
0
China
Query!
State/province [106]
0
0
Beijing
Query!
Country [107]
0
0
China
Query!
State/province [107]
0
0
Shanghai
Query!
Country [108]
0
0
China
Query!
State/province [108]
0
0
Tianjin
Query!
Country [109]
0
0
Colombia
Query!
State/province [109]
0
0
Antioquia
Query!
Country [110]
0
0
Colombia
Query!
State/province [110]
0
0
Atlantico
Query!
Country [111]
0
0
Colombia
Query!
State/province [111]
0
0
Atlántico
Query!
Country [112]
0
0
Colombia
Query!
State/province [112]
0
0
Cundinamarca
Query!
Country [113]
0
0
Colombia
Query!
State/province [113]
0
0
Distrito Capital De Bogotá
Query!
Country [114]
0
0
Colombia
Query!
State/province [114]
0
0
Quindío
Query!
Country [115]
0
0
Colombia
Query!
State/province [115]
0
0
Valle Del Cauca
Query!
Country [116]
0
0
Colombia
Query!
State/province [116]
0
0
Cali
Query!
Country [117]
0
0
Colombia
Query!
State/province [117]
0
0
Florida Blanca
Query!
Country [118]
0
0
Colombia
Query!
State/province [118]
0
0
Floridablabca
Query!
Country [119]
0
0
Colombia
Query!
State/province [119]
0
0
Medellin
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Brno
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Ceské Budejovice
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Chomutov
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Jihlava
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Karvina
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Liberec
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Ostrava - Poruba
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Ostrava - Vitkovice
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Pardubice
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Praha 4
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Praha 5-Motol
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Praha 6
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Praha
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Zlín
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Ústí nad Labem
Query!
Country [135]
0
0
Denmark
Query!
State/province [135]
0
0
Aalborg
Query!
Country [136]
0
0
Denmark
Query!
State/province [136]
0
0
Aarhus N
Query!
Country [137]
0
0
Denmark
Query!
State/province [137]
0
0
Glostrup
Query!
Country [138]
0
0
Denmark
Query!
State/province [138]
0
0
Herlev
Query!
Country [139]
0
0
Denmark
Query!
State/province [139]
0
0
Herning
Query!
Country [140]
0
0
Denmark
Query!
State/province [140]
0
0
Kolding
Query!
Country [141]
0
0
Denmark
Query!
State/province [141]
0
0
København NV
Query!
Country [142]
0
0
Denmark
Query!
State/province [142]
0
0
Odense C
Query!
Country [143]
0
0
Finland
Query!
State/province [143]
0
0
Helsinki
Query!
Country [144]
0
0
Finland
Query!
State/province [144]
0
0
Joensuu
Query!
Country [145]
0
0
Finland
Query!
State/province [145]
0
0
Kuopio
Query!
Country [146]
0
0
Finland
Query!
State/province [146]
0
0
Tampere
Query!
Country [147]
0
0
Finland
Query!
State/province [147]
0
0
Turku
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Besancon
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
BORDEAUX cedex
Query!
Country [150]
0
0
France
Query!
State/province [150]
0
0
Boulogne-sur-mer
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Brest Cedex
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
Corbeil-essonnes
Query!
Country [153]
0
0
France
Query!
State/province [153]
0
0
DIJON Cedex
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Garches
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Le Kremlin-bicetre
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Le Mans
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Lille
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
LOMME cedex
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Lyon
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Marseille
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Nancy
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Nantes
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Nice
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Nîmes
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Paris
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Reims
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Rennes Cedex
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Strasbourg
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
SURESNES Cedex
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Toulon cedex 09
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Toulouse
Query!
Country [172]
0
0
France
Query!
State/province [172]
0
0
TOURS cedex 9
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Baden-Württemberg
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Bayern
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Hessen
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Mecklenburg-Vorpommern
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Niedersachsen
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Nordrhein-Westfalen
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Rheinland-Pfalz
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Sachsen-Anhalt
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Sachsen
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Thüringen
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Berlin
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Hamburg
Query!
Country [185]
0
0
Greece
Query!
State/province [185]
0
0
Alexandroupolis
Query!
Country [186]
0
0
Greece
Query!
State/province [186]
0
0
Athens
Query!
Country [187]
0
0
Greece
Query!
State/province [187]
0
0
Chaidari
Query!
Country [188]
0
0
Greece
Query!
State/province [188]
0
0
Heraklion
Query!
Country [189]
0
0
Greece
Query!
State/province [189]
0
0
Ioannina
Query!
Country [190]
0
0
Greece
Query!
State/province [190]
0
0
Larissa
Query!
Country [191]
0
0
Greece
Query!
State/province [191]
0
0
Neo Faliro Piraeus
Query!
Country [192]
0
0
Greece
Query!
State/province [192]
0
0
Patra
Query!
Country [193]
0
0
Greece
Query!
State/province [193]
0
0
Pilea Chortiatis
Query!
Country [194]
0
0
Greece
Query!
State/province [194]
0
0
Thessaloniki
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Baja
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Budapest
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Debrecen
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Gyor
Query!
Country [199]
0
0
Hungary
Query!
State/province [199]
0
0
Kistarcsa
Query!
Country [200]
0
0
Hungary
Query!
State/province [200]
0
0
Kisvarda
Query!
Country [201]
0
0
Hungary
Query!
State/province [201]
0
0
Nagykanizsa
Query!
Country [202]
0
0
Hungary
Query!
State/province [202]
0
0
Nyiregyhaza
Query!
Country [203]
0
0
Hungary
Query!
State/province [203]
0
0
Pecs
Query!
Country [204]
0
0
Hungary
Query!
State/province [204]
0
0
Sopron
Query!
Country [205]
0
0
Hungary
Query!
State/province [205]
0
0
Szeged
Query!
Country [206]
0
0
Hungary
Query!
State/province [206]
0
0
Zalaegerszeg
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Andhra Pradesh
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Gujarat
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Karnataka
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Kerala
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Telangana
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Chandigarh
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
Coimbatore
Query!
Country [214]
0
0
India
Query!
State/province [214]
0
0
Gurgaon
Query!
Country [215]
0
0
India
Query!
State/province [215]
0
0
Guwahati
Query!
Country [216]
0
0
India
Query!
State/province [216]
0
0
Hyderabad
Query!
Country [217]
0
0
India
Query!
State/province [217]
0
0
Jaipur
Query!
Country [218]
0
0
India
Query!
State/province [218]
0
0
Karamsad
Query!
Country [219]
0
0
India
Query!
State/province [219]
0
0
Kolkata
Query!
Country [220]
0
0
India
Query!
State/province [220]
0
0
Ludhiana
Query!
Country [221]
0
0
India
Query!
State/province [221]
0
0
Nagpur
Query!
Country [222]
0
0
India
Query!
State/province [222]
0
0
New Delhi
Query!
Country [223]
0
0
India
Query!
State/province [223]
0
0
Pune
Query!
Country [224]
0
0
India
Query!
State/province [224]
0
0
Thiruvananthapuram
Query!
Country [225]
0
0
India
Query!
State/province [225]
0
0
Vellore
Query!
Country [226]
0
0
Israel
Query!
State/province [226]
0
0
Ashdod
Query!
Country [227]
0
0
Israel
Query!
State/province [227]
0
0
Ashkelon
Query!
Country [228]
0
0
Israel
Query!
State/province [228]
0
0
Beer Sheva
Query!
Country [229]
0
0
Israel
Query!
State/province [229]
0
0
Hadera
Query!
Country [230]
0
0
Israel
Query!
State/province [230]
0
0
Haifa
Query!
Country [231]
0
0
Israel
Query!
State/province [231]
0
0
Holon
Query!
Country [232]
0
0
Israel
Query!
State/province [232]
0
0
Jerusalem
Query!
Country [233]
0
0
Israel
Query!
State/province [233]
0
0
Kfar Saba
Query!
Country [234]
0
0
Israel
Query!
State/province [234]
0
0
Petach Tikva
Query!
Country [235]
0
0
Israel
Query!
State/province [235]
0
0
Ramat Gan
Query!
Country [236]
0
0
Israel
Query!
State/province [236]
0
0
Tel Aviv
Query!
Country [237]
0
0
Israel
Query!
State/province [237]
0
0
Zefat
Query!
Country [238]
0
0
Israel
Query!
State/province [238]
0
0
Zerifin
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Abruzzo
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Campania
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
Emilia-Romagna
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
Friuli-Venezia Giulia
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
Lazio
Query!
Country [244]
0
0
Italy
Query!
State/province [244]
0
0
Liguria
Query!
Country [245]
0
0
Italy
Query!
State/province [245]
0
0
Lombardia
Query!
Country [246]
0
0
Italy
Query!
State/province [246]
0
0
Puglia
Query!
Country [247]
0
0
Italy
Query!
State/province [247]
0
0
Sicilia
Query!
Country [248]
0
0
Italy
Query!
State/province [248]
0
0
Toscana
Query!
Country [249]
0
0
Italy
Query!
State/province [249]
0
0
Umbria
Query!
Country [250]
0
0
Italy
Query!
State/province [250]
0
0
Veneto
Query!
Country [251]
0
0
Italy
Query!
State/province [251]
0
0
Ancona
Query!
Country [252]
0
0
Italy
Query!
State/province [252]
0
0
Torino
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Aichi
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Chiba
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Fukuoka
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Fukushima
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Gifu
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Gunma
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Hiroshima
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Hokkaido
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Hyogo
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Ibaraki
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Kagawa
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Kanagawa
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Kyoto
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Miyagi
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Nagano-ken
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Nagano
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Oita
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Okayama
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Osaka
Query!
Country [272]
0
0
Japan
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Saga
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Wakayama
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Japan
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Yamaguchi
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Japan
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Yamanashi
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Japan
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Kagoshima
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Japan
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Kochi
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Japan
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Kumamoto
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Kazakhstan
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Aktobe
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Almaty
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Shymkent
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Chungcheongbugdo
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Daegu Gwang''yeogsi
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Gyeonggido
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Seoul Teugbyeolsi
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Busan
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Incheon
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Seoul,
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Seoul
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Riga
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Kaunas
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Lørenskog
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Molde
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Oslo
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Trondheim
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Norway
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Ålesund
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Bialystok
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Grodzisk Mazowiecki
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Katowice
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Opole
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Lisboa
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Porto
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Portugal
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Setúbal
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Portugal
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Coimbra
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Iasi
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Romania
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Oradea
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Romania
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Sibiu
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Romania
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Suceava
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Romania
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Targu Mures
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Romania
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Timisoara
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Bratislava
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Dolny Kubin
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Komarno
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Levoca
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Slovakia
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Slovakia
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Lucenec
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Martin
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Presov
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Skalica
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Slovakia
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Trnava
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Slovakia
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Ziar nad Hronom
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Spain
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Spain
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Albacete
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Spain
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Girona
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Spain
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León
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Spain
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Lleida
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Tarragona
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Spain
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Valencia
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Spain
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Spain
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Zaragoza
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Danderyd
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Lund
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Stockholm
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Sweden
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Uppsala
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Sweden
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Östersund
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Aargau
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Genève
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Sankt Gallen
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Ticino
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Vaud
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Bern
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Zürich
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Changhua
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Taiwan
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Keelung
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Tainan
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Taipei City
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Taiwan
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Taoyuan
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Turkey
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Elazig
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Konya
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Samsun
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Sivas
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London
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Manchester
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Staffordshire
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United Kingdom
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Tyne And Wear
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West Yorkshire
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United Kingdom
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Derby
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Edinburgh
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Exeter
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: * an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or * TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: * Check vital signs such as blood pressure and heart rate * Examine the participants' heart health using an electrocardiogram (ECG) * Take blood samples * Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.
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Trial website
https://clinicaltrials.gov/study/NCT05686070
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Public notes
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Contacts
Principal investigator
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Bayer Clinical Trials Contact
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(+)1-888-84 22937
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Query!
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/NCT05686070