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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00799903
Registration number
NCT00799903
Ethics application status
Date submitted
26/11/2008
Date registered
1/12/2008
Titles & IDs
Public title
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
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Scientific title
LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
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Secondary ID [1]
0
0
100601
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Universal Trial Number (UTN)
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Trial acronym
STABILITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis
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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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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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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 - Darapladib
Treatment: Drugs - Placebo
Experimental: Darapladib - Single daily oral tablet
Placebo comparator: Placebo - Single daily oral tablet
Treatment: Drugs: Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy
Treatment: Drugs: Placebo
Placebo administered in addition to standard therapy
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Intervention code [1]
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0
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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Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
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Assessment method [1]
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CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \>24 hours or results in death (in \<24 hours).
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Timepoint [1]
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [1]
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Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events
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Assessment method [1]
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CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention \[PCI: any attempt at CR even if not successful\] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.
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Timepoint [1]
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [2]
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Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events
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Assessment method [2]
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CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.
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Timepoint [2]
0
0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [3]
0
0
Number of Participants With CV Death During the Time Period for Follow-up of CV Events
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Assessment method [3]
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CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
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Timepoint [3]
0
0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [4]
0
0
Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
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Assessment method [4]
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Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
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Timepoint [4]
0
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [5]
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Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
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Assessment method [5]
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Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \>24 hours or results in death (in \<24 hours).
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Timepoint [5]
0
0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [6]
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Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events
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Assessment method [6]
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Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \>24 hours or results in death (in \<24 hours).
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Timepoint [6]
0
0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
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Secondary outcome [7]
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0
Number of Participants With All-cause Mortality During the Time Period for Vital Status
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Assessment method [7]
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The number of participants with all-cause mortality was assessed.
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Timepoint [7]
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From randomization until death or study completion (up to 4.49 years/average of 3.65 years)
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Eligibility
Key inclusion criteria
* Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
* Chronic coronary heart disease
* At least one of the following:
* At least 60 years old
* Diabetes requiring treatment with medication
* Low HDL cholesterol ("good cholesterol")
* Currently smoke cigarettes or stopped smoking within the past 3 months
* Diagnosed mild or moderate reduction in kidney function
* Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.
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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
* Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
* Liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Severe heart failure
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
* Severe asthma that is poorly controlled with medication
* Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
* Previous severe allergic response to food, drink, insect stings, etc.
* Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
* Certain medications that may interfere with the study medication (these will be identified by the study doctor)
* Participation in a study of an investigational medication within the past 30 days
* Current participation in a study of an investigational device
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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
Completed
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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
1/12/2008
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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
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Actual
17/10/2013
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Sample size
Target
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Accrual to date
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Final
15828
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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Recruitment hospital [2]
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GSK Investigational Site - Coffs Harbour
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Recruitment hospital [3]
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GSK Investigational Site - Concord
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GSK Investigational Site - Gosford
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Recruitment hospital [5]
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GSK Investigational Site - Liverpool
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Recruitment hospital [6]
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GSK Investigational Site - Auchenflower
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Recruitment hospital [7]
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GSK Investigational Site - Kippa Ring
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Recruitment hospital [8]
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GSK Investigational Site - Sherwood
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Recruitment hospital [9]
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GSK Investigational Site - Bedford Park
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Recruitment hospital [10]
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GSK Investigational Site - Ballarat
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Recruitment hospital [11]
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GSK Investigational Site - Caulfield South
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Recruitment hospital [12]
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GSK Investigational Site - Frankston
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Recruitment hospital [13]
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GSK Investigational Site - Malvern
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Recruitment hospital [14]
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GSK Investigational Site - Fremantle
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Recruitment hospital [15]
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GSK Investigational Site - Joondalup
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Recruitment hospital [16]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2606 - Garran
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Recruitment postcode(s) [2]
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2450 - Coffs Harbour
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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2250 - Gosford
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Recruitment postcode(s) [5]
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2170 - Liverpool
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Recruitment postcode(s) [6]
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4066 - Auchenflower
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Recruitment postcode(s) [7]
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4021 - Kippa Ring
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Recruitment postcode(s) [8]
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4075 - Sherwood
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Recruitment postcode(s) [9]
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5042 - Bedford Park
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Recruitment postcode(s) [10]
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- Ballarat
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Recruitment postcode(s) [11]
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3162 - Caulfield South
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Recruitment postcode(s) [12]
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3199 - Frankston
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Recruitment postcode(s) [13]
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3144 - Malvern
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Recruitment postcode(s) [14]
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6160 - Fremantle
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Recruitment postcode(s) [15]
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6027 - Joondalup
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Recruitment postcode(s) [16]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Illinois
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Argentina
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Buenos Aires
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Aalst
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Antwerpen
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Bonheiden
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Bruxelles
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Roeselaere
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Brazil
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Goiás
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Rio Grande Do Sul
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Brazil
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Bulgaria
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Dimitrovgrad
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Bulgaria
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Pleven
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Plovdiv
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Ruse
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Sofia
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Bulgaria
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Veliko Tarnovo
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Canada
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Alberta
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Canada
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Canada
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Ontario
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Quebec
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Chile
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Región Del Biobio
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Chile
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Región Metro De Santiago
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Chile
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0
Valparaíso
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Guangdong
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Jiangsu
Query!
Country [84]
0
0
China
Query!
State/province [84]
0
0
Shaanxi
Query!
Country [85]
0
0
China
Query!
State/province [85]
0
0
Shandong
Query!
Country [86]
0
0
China
Query!
State/province [86]
0
0
Zhejiang
Query!
Country [87]
0
0
China
Query!
State/province [87]
0
0
Beijing
Query!
Country [88]
0
0
China
Query!
State/province [88]
0
0
Guangzhou
Query!
Country [89]
0
0
China
Query!
State/province [89]
0
0
Haerbin
Query!
Country [90]
0
0
China
Query!
State/province [90]
0
0
Shanghai
Query!
Country [91]
0
0
China
Query!
State/province [91]
0
0
Wuhan
Query!
Country [92]
0
0
Czechia
Query!
State/province [92]
0
0
Caslav
Query!
Country [93]
0
0
Czechia
Query!
State/province [93]
0
0
Chomutov
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Chrudim
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Jihlava
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Kladno
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Kolin
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Kromeriz
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Milevsko
Query!
Country [100]
0
0
Czechia
Query!
State/province [100]
0
0
Pisek
Query!
Country [101]
0
0
Czechia
Query!
State/province [101]
0
0
Praha 2
Query!
Country [102]
0
0
Czechia
Query!
State/province [102]
0
0
Pribram
Query!
Country [103]
0
0
Czechia
Query!
State/province [103]
0
0
Slany
Query!
Country [104]
0
0
Czechia
Query!
State/province [104]
0
0
Svitavy
Query!
Country [105]
0
0
Czechia
Query!
State/province [105]
0
0
Tabor
Query!
Country [106]
0
0
Czechia
Query!
State/province [106]
0
0
Usti nad Orlici
Query!
Country [107]
0
0
Denmark
Query!
State/province [107]
0
0
Aarhus
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Esbjerg
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
Koebenhavn OE
Query!
Country [110]
0
0
Denmark
Query!
State/province [110]
0
0
Silkeborg
Query!
Country [111]
0
0
Estonia
Query!
State/province [111]
0
0
Tallinn
Query!
Country [112]
0
0
Estonia
Query!
State/province [112]
0
0
Tartu
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Aix en Provence cedex 1
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Avignon
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Besançon Cedex
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Bron Cedex
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Créteil
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Dijon
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Lille Cedex
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Marseille cedex 5
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Metz Cedex 03
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Nantes Cedex 1
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Narbonne Cedex
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Nimes
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Paris Cedex 13
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Paris Cedex 18
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Paris
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Pessac cedex
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Roubaix
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Strasbourg cedex
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Toulouse Cedex 09
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Tourcoing
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Baden-Wuerttemberg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Bayern
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Brandenburg
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Hessen
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Niedersachsen
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Nordrhein-Westfalen
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Rheinland-Pfalz
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Sachsen-Anhalt
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Sachsen
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Berlin
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Hamburg
Query!
Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Agia Varvara, Athens
Query!
Country [145]
0
0
Greece
Query!
State/province [145]
0
0
Alexandroupolis
Query!
Country [146]
0
0
Greece
Query!
State/province [146]
0
0
Athens
Query!
Country [147]
0
0
Greece
Query!
State/province [147]
0
0
Chalkida
Query!
Country [148]
0
0
Greece
Query!
State/province [148]
0
0
Ioannina
Query!
Country [149]
0
0
Greece
Query!
State/province [149]
0
0
Magoula, Elefsina
Query!
Country [150]
0
0
Greece
Query!
State/province [150]
0
0
Patras
Query!
Country [151]
0
0
Greece
Query!
State/province [151]
0
0
Thessaloniki
Query!
Country [152]
0
0
Greece
Query!
State/province [152]
0
0
Voula / Athens
Query!
Country [153]
0
0
Hong Kong
Query!
State/province [153]
0
0
Hong Kong
Query!
Country [154]
0
0
Hong Kong
Query!
State/province [154]
0
0
Shatin, New Territories
Query!
Country [155]
0
0
Hungary
Query!
State/province [155]
0
0
Berettyóújfalu
Query!
Country [156]
0
0
Hungary
Query!
State/province [156]
0
0
Budapest
Query!
Country [157]
0
0
Hungary
Query!
State/province [157]
0
0
Esztergom
Query!
Country [158]
0
0
Hungary
Query!
State/province [158]
0
0
Gyula
Query!
Country [159]
0
0
Hungary
Query!
State/province [159]
0
0
Komárom
Query!
Country [160]
0
0
Hungary
Query!
State/province [160]
0
0
Mosonmagyaróvár
Query!
Country [161]
0
0
Hungary
Query!
State/province [161]
0
0
Szikszó
Query!
Country [162]
0
0
Hungary
Query!
State/province [162]
0
0
Szolnok
Query!
Country [163]
0
0
Hungary
Query!
State/province [163]
0
0
Székesfehérvár
Query!
Country [164]
0
0
Hungary
Query!
State/province [164]
0
0
Sátoraljaújhely
Query!
Country [165]
0
0
India
Query!
State/province [165]
0
0
Ahmedabad
Query!
Country [166]
0
0
India
Query!
State/province [166]
0
0
Bangalore
Query!
Country [167]
0
0
India
Query!
State/province [167]
0
0
Cochin
Query!
Country [168]
0
0
India
Query!
State/province [168]
0
0
Jaipur
Query!
Country [169]
0
0
India
Query!
State/province [169]
0
0
Mysore
Query!
Country [170]
0
0
India
Query!
State/province [170]
0
0
New Delhi
Query!
Country [171]
0
0
India
Query!
State/province [171]
0
0
Patiala
Query!
Country [172]
0
0
India
Query!
State/province [172]
0
0
Pune
Query!
Country [173]
0
0
India
Query!
State/province [173]
0
0
Saket,Delhi
Query!
Country [174]
0
0
India
Query!
State/province [174]
0
0
Vadodara
Query!
Country [175]
0
0
India
Query!
State/province [175]
0
0
Vijayawada
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Abruzzo
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Campania
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Emilia-Romagna
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Lazio
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Lombardia
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Marche
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Piemonte
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Toscana
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Veneto
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Aichi
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Chiba
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Fukuoka
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Hokkaido
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Kagoshima
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Kanagawa
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Kyoto
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Nagano
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Nagasaki
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Oita
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Osaka
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Shiga
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Shizuoka
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Tokyo
Query!
Country [199]
0
0
Korea, Republic of
Query!
State/province [199]
0
0
Cheongju
Query!
Country [200]
0
0
Korea, Republic of
Query!
State/province [200]
0
0
Dae-Gu
Query!
Country [201]
0
0
Korea, Republic of
Query!
State/province [201]
0
0
Gangnam-gu, Seoul
Query!
Country [202]
0
0
Korea, Republic of
Query!
State/province [202]
0
0
Gwangju
Query!
Country [203]
0
0
Korea, Republic of
Query!
State/province [203]
0
0
jeonju-si, Jeollabuk-Do
Query!
Country [204]
0
0
Korea, Republic of
Query!
State/province [204]
0
0
Seo-gu Busan
Query!
Country [205]
0
0
Korea, Republic of
Query!
State/province [205]
0
0
Seongnam-si Gyeonggi-do
Query!
Country [206]
0
0
Korea, Republic of
Query!
State/province [206]
0
0
Seoul
Query!
Country [207]
0
0
Korea, Republic of
Query!
State/province [207]
0
0
Uijeongbu-si Kyonggi-do
Query!
Country [208]
0
0
Mexico
Query!
State/province [208]
0
0
Nuevo León
Query!
Country [209]
0
0
Mexico
Query!
State/province [209]
0
0
Durango
Query!
Country [210]
0
0
Mexico
Query!
State/province [210]
0
0
Mexico
Query!
Country [211]
0
0
Mexico
Query!
State/province [211]
0
0
México D.F,
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Amsterdam
Query!
Country [213]
0
0
Netherlands
Query!
State/province [213]
0
0
Beverwijk
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
Den Haag
Query!
Country [215]
0
0
Netherlands
Query!
State/province [215]
0
0
Doetinchem
Query!
Country [216]
0
0
Netherlands
Query!
State/province [216]
0
0
Eindhoven
Query!
Country [217]
0
0
Netherlands
Query!
State/province [217]
0
0
Enschede
Query!
Country [218]
0
0
Netherlands
Query!
State/province [218]
0
0
Goes
Query!
Country [219]
0
0
Netherlands
Query!
State/province [219]
0
0
Harderwijk
Query!
Country [220]
0
0
Netherlands
Query!
State/province [220]
0
0
Hoofddorp
Query!
Country [221]
0
0
Netherlands
Query!
State/province [221]
0
0
Leeuwarden
Query!
Country [222]
0
0
Netherlands
Query!
State/province [222]
0
0
Rotterdam
Query!
Country [223]
0
0
Netherlands
Query!
State/province [223]
0
0
Sittard-geleen
Query!
Country [224]
0
0
Netherlands
Query!
State/province [224]
0
0
Sneek
Query!
Country [225]
0
0
Netherlands
Query!
State/province [225]
0
0
Tiel
Query!
Country [226]
0
0
New Zealand
Query!
State/province [226]
0
0
Christchurch
Query!
Country [227]
0
0
New Zealand
Query!
State/province [227]
0
0
Dunedin
Query!
Country [228]
0
0
New Zealand
Query!
State/province [228]
0
0
Grafton, Auckland
Query!
Country [229]
0
0
New Zealand
Query!
State/province [229]
0
0
Hamilton
Query!
Country [230]
0
0
New Zealand
Query!
State/province [230]
0
0
Lower Hutt
Query!
Country [231]
0
0
New Zealand
Query!
State/province [231]
0
0
Nelson
Query!
Country [232]
0
0
New Zealand
Query!
State/province [232]
0
0
Otahuhu, Auckland
Query!
Country [233]
0
0
New Zealand
Query!
State/province [233]
0
0
Palmerston North
Query!
Country [234]
0
0
New Zealand
Query!
State/province [234]
0
0
Takapuna, Auckland
Query!
Country [235]
0
0
New Zealand
Query!
State/province [235]
0
0
Tauranga
Query!
Country [236]
0
0
New Zealand
Query!
State/province [236]
0
0
Timaru
Query!
Country [237]
0
0
New Zealand
Query!
State/province [237]
0
0
Whangarei
Query!
Country [238]
0
0
Norway
Query!
State/province [238]
0
0
Bergen
Query!
Country [239]
0
0
Norway
Query!
State/province [239]
0
0
Moss
Query!
Country [240]
0
0
Norway
Query!
State/province [240]
0
0
Oslo
Query!
Country [241]
0
0
Pakistan
Query!
State/province [241]
0
0
Karachi
Query!
Country [242]
0
0
Pakistan
Query!
State/province [242]
0
0
Korangi / Karachi
Query!
Country [243]
0
0
Pakistan
Query!
State/province [243]
0
0
Lahore
Query!
Country [244]
0
0
Pakistan
Query!
State/province [244]
0
0
Multan
Query!
Country [245]
0
0
Pakistan
Query!
State/province [245]
0
0
Rawalpindi Cantt
Query!
Country [246]
0
0
Peru
Query!
State/province [246]
0
0
Lima
Query!
Country [247]
0
0
Peru
Query!
State/province [247]
0
0
Callao
Query!
Country [248]
0
0
Philippines
Query!
State/province [248]
0
0
Ermita, Manila
Query!
Country [249]
0
0
Philippines
Query!
State/province [249]
0
0
Manila
Query!
Country [250]
0
0
Philippines
Query!
State/province [250]
0
0
Quezon City
Query!
Country [251]
0
0
Philippines
Query!
State/province [251]
0
0
San Juan
Query!
Country [252]
0
0
Poland
Query!
State/province [252]
0
0
Bydgoszcz
Query!
Country [253]
0
0
Poland
Query!
State/province [253]
0
0
Gdynia
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Kowanowko
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Krakow
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Mielec
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Ostrow Wielkopolski
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Plonsk
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Radom
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Ruda Slaska
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Siemianowice Slaskie
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Skierniewice
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Torun
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Funding & Sponsors
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Commercial sector/industry
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Name
GlaxoSmithKline
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Summary
Brief summary
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.
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Trial website
https://clinicaltrials.gov/study/NCT00799903
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Trial related presentations / publications
Sjolin K, Aulin J, Wallentin L, Eriksson N, Held C, Kultima K, Oldgren J, Burman J. Serum Neurofilament Light Chain in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jul 19;11(14):e025910. doi: 10.1161/JAHA.122.025910. Epub 2022 Jul 15. Held C, Hadziosmanovic N, Aylward PE, Hagstrom E, Hochman JS, Stewart RAH, White HD, Wallentin L. Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy. J Am Heart Assoc. 2022 Feb;11(3):e023667. doi: 10.1161/JAHA.121.023667. Epub 2022 Jan 21. Siddiqui MK, Smith G, St Jean P, Dawed AY, Bell S, Soto-Pedre E, Kennedy G, Carr F, Wallentin L, White H, Macphee CH, Waterworth D, Palmer CNA. Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events. Diabetologia. 2022 Jan;65(1):101-112. doi: 10.1007/s00125-021-05574-5. Epub 2021 Sep 25. Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagstrom E, Held C, Kleber ME, Koenig W, Marz W, Stewart RAH, White HD, Aberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan. White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18. Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylha A, Lindback J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy. J Am Heart Assoc. 2020 May 18;9(10):e015258. doi: 10.1161/JAHA.119.015258. Epub 2020 May 7. Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and Lifestyle Risk Factors and Cognitive Function in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2019 Apr 2;8(7):e010641. doi: 10.1161/JAHA.118.010641. Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Ostlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077. Hagstrom E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, Lopez-Sendon J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23. Guimaraes PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagstrom E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9):e006695. doi: 10.1161/JAHA.117.006695. Stewart RAH, Hagstrom E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, Lopez-Sendon JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8):e006096. doi: 10.1161/JAHA.117.006096. Lindholm D, Lindback J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagstrom E, Held C, Koenig W, Ostlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, Marz W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030. Vedin O, Hagstrom E, Ostlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17. Hagstrom E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Ostlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3. Wallentin L, Held C, Armstrong PW, Cannon CP, Davies RY, Granger CB, Hagstrom E, Harrington RA, Hochman JS, Koenig W, Krug-Gourley S, Mohler ER 3rd, Siegbahn A, Tarka E, Steg PG, Stewart RA, Weiss R, Ostlund O, White HD; STABILITY Investigators. Lipoprotein-Associated Phospholipase A2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2016 Jun 21;5(6):e003407. doi: 10.1161/JAHA.116.003407. Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25. Vedin O, Hagstrom E, Budaj A, Denchev S, Harrington RA, Koenig W, Soffer J, Sritara P, Stebbins A, Stewart RH, Swart HP, Viigimaa M, Vinereanu D, Wallentin L, White HD, Held C; STABILITY Investigators. Tooth loss is independently associated with poor outcomes in stable coronary heart disease. Eur J Prev Cardiol. 2016 May;23(8):839-46. doi: 10.1177/2047487315621978. Epub 2015 Dec 16. Vedin O, Hagstrom E, Gallup D, Neely ML, Stewart R, Koenig W, Budaj A, Sritara P, Wallentin L, White HD, Held C. Periodontal disease in patients with chronic coronary heart disease: Prevalence and association with cardiovascular risk factors. Eur J Prev Cardiol. 2015 Jun;22(6):771-8. doi: 10.1177/2047487314530660. Epub 2014 Apr 10. STABILITY Investigators; White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, Lopez-Sendon J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30. Vedin O, Hagstrom E, Stewart R, Brown R, Krug-Gourley S, Davies R, Wallentin L, White H, Held C. Secondary prevention and risk factor target achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2013 Aug;20(4):678-85. doi: 10.1177/2047487312444995. Epub 2012 Apr 10.
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Public notes
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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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?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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How or where can data be obtained?
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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 are available at
https://clinicaltrials.gov/study/NCT00799903