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Trial registered on ANZCTR
Registration number
ACTRN12619001445167
Ethics application status
Approved
Date submitted
10/10/2019
Date registered
18/10/2019
Date last updated
22/11/2024
Date data sharing statement initially provided
18/10/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Biomarker-guided Management Following a Heart Attack
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Scientific title
Effect of cardiac biomarker (Nt-proBNP and high sensitivity troponin) guided risk management on clinical outcomes (all-cause mortality and cardiovascular readmission) in patients in the convalescent phase following Acute Coronary Syndromes: a Randomised, Controlled Trial
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Secondary ID [1]
299490
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Nil Known
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Universal Trial Number (UTN)
U1111-1238-9283
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Trial acronym
BioMACS
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Linked study record
No
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Health condition
Health condition(s) or problem(s) studied:
Secondary prevention post-acute coronary syndromes
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Cardiovascular Disease
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Condition category
Condition code
Cardiovascular
313058
313058
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All patients will be seen between 1 and 12 months post hospital discharge for ACS, and have a baseline assessment. The patients will have NT-proBNP and high-sensitivity troponin measured, for those patients in the intervention group if the NT-proBNP is greater than 15pmol/L or NT-proBNP less than 15pmol/L with hsTnT greater than the 99th centile then existing renin-angiotensin inhibitor and beta-blocker will be titrated to maximum tolerated dosages. No pre-specified specific individual drug will be used. The drugs to be titrated will be the medications that the patients were on when they were discharged from hospital. Example would be titration of cilazapril to 5mg/day or maximum tolerated dose and bisoprolol to 10mg/day or maximum tolerated dose (upper limits of these medications will not be exceeded)
Maximum tolerated dosages will be determined by absence of symptoms such as postural dizziness for more than 2 weeks.
Titration protocol will be to aim to double the dose of these medications every 2 weeks. Duration of the study for these medications is 24 months post-enrolment
Adherence will be discussed with the patients at every visit but other specific strategies will not be utilised in this study.
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Intervention code [1]
315772
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Treatment: Drugs
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Intervention code [2]
315802
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Treatment: Other
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Comparator / control treatment
The control group patients will be those allocated to the control group after the baseline assessment and following the randomisation process. The cardiac biomarkers NT-proBNP and high sensitivity troponin will be measured but the study team and patient will be blinded to the result. The control group patients will continue to receive their usual medications but the dosages will not be titrated within the study protocol.
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Control group
Active
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Outcomes
Primary outcome [1]
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Composite outcome of time to first event of death from any cause or cardiovascular readmission Clinical outcome data will be collected by linkage to the NZ national mortality and hospitalisation databases.
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Assessment method [1]
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Timepoint [1]
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18 Months post-randomisation
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Primary outcome [2]
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Hierarchical composite, stratified by baseline risk: 1. Death from any cause 2. Hospitalisation for recurrent ACS or heart failure 3. Hospitalisation for other IHD (including coronary revascularisation [CABG or PCI] during unplanned hospital admission) 4. Hospitalisation for cerebrovascular disease (including stroke and TIA) 5. Change in systolic blood pressure from baseline to 3 months Clinical events will be collected by anonymised linkage to the NZ national datasets (mortality and hospitalisations). All events in the hierarchical end-point will be collected with higher priority given to the most severe event (as per the order of the events listed).
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Assessment method [2]
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Timepoint [2]
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Median follow up 2 years post-randomisation
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Secondary outcome [1]
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Time to first cardiovascular readmission 18 months post-randomisation Clinical outcome data will be collected by linkage to the NZ national mortality and hospitalisation databases.
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Assessment method [1]
375690
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Timepoint [1]
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18 months post-randomisation
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Secondary outcome [2]
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Death from any cause (national administrative dataset linkage)
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Assessment method [2]
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Timepoint [2]
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Median follow up of 2 years post-randomisation
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Secondary outcome [3]
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Hospitalisation for recurrent ACS or heart failure (national administrative dataset linkages)
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Assessment method [3]
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Timepoint [3]
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Median follow up of 2 years post-randomisation
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Secondary outcome [4]
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Hospitalisation for recurrent ACS or heart failure (national administrative dataset linkages)
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Assessment method [4]
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Timepoint [4]
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Median follow up 2 years post-randomisation
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Secondary outcome [5]
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Hospitalisation for other IHD event (defined as any IHD ICD coded event excluding ACS: data from national administrative dataset linkages)
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Assessment method [5]
442115
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Timepoint [5]
442115
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Median follow up 2 years post-randomisation
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Secondary outcome [6]
442116
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Hospitalisation for other IHD event (defined as any IHD ICD coded event excluding ACS: data from national administrative dataset linkages)
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Assessment method [6]
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Timepoint [6]
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The trial commenced in December 2019, was delayed during the pandemic, end-point revised as per the previous section (primary end-point) Enrolment still ongoing when this revision was made Median follow up 2 years post-randomisation
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Secondary outcome [7]
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Hospitalisation for cerebrovascular disease (data available from national administrative dataset linkages)
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Assessment method [7]
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Timepoint [7]
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The trial commenced in December 2019, was delayed during the pandemic, end-point revised as per the previous section (primary end-point) Enrolment still ongoing when this revision was made Median follow up 2 years post-randomisation
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Secondary outcome [8]
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Change in systolic blood pressure from baseline to 3 months (BP recorded by sphygmomanometer at clinic visit)
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Assessment method [8]
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Timepoint [8]
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The trial commenced in December 2019, was delayed during the pandemic, end-point revised as per the previous section (primary end-point) Enrolment still ongoing when this revision was made Median follow up 2 years post-randomisation
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Secondary outcome [9]
442120
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Change in systolic blood pressure from baseline to 3 months (BP recorded by sphygmomanometer at clinic visit)
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Assessment method [9]
442120
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Timepoint [9]
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Baseline to 3 month follow up post-randomisation
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Eligibility
Key inclusion criteria
Primary diagnosis of acute coronary syndrome
Age > 18yrs
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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
Previously known left ventricular ejection fraction < 35%,
severe aortic stenosis
other life-limiting disease (life expectancy<1 year),
end-stage renal disease (eGFR < 15mL/min) or
inability to provide consent
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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)
Online electronic randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary end point will be analysed using the win ratio approach using patient pairs within the same strata of risk which reduces variability and thus enhances statistical power.
BioMACS has a 1:1 randomisation, we assume a 20% reduction in risk with the Intervention, and if only 10% of the cohort end up with a tie at the end of the hierarchy of outcome comparisons, we need 1028 people in the trial for 80% power.
Statistical analyses will be undertaken by study statistician using the software "R".
A formal statistical analysis plan will be developed to prospectively detail the approach to analysis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
9/12/2019
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Actual
2/12/2019
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1028
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Accrual to date
948
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Final
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Recruitment outside Australia
Country [1]
21914
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New Zealand
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State/province [1]
21914
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NZ Health Research Council
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Address [1]
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110 Stanley Street, Auckland, 1010
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Professor Rob Doughty
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Address
University of Auckland, Park Road, Grafton, Auckland 1024, NZ
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
304159
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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28/08/2019
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Approval date [1]
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25/11/2019
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Ethics approval number [1]
304484
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Summary
Brief summary
Patients who present with a heart attack are at risk of recurrent heart events in the next few years. A simple blood test can measure whether the heart is under stress. If this blood test is elevated then the potential is for specific medications to be used to reduce the risk of further heart events. The hypothesis is that a biomarker-guided approach to risk assessment and management will reduce the risk of recurrent clinical events for people following heart attacks. Patients will be those discharged from hospital following a heart attack within the last 1-12 months. Patients will be randomised (1:1) to either usual care group or to biomarker group. A stratified approach to patient management will be undertaken for the patients in the biomarker group, using heart biomarkers measured at the baseline visit. The “low biomarker” subgroup will be defined by NT-proBNP less than15pmol/L and hsTnT<99th centile; these patients will continue with follow up as per the usual care group. The “high biomarker” subgroup (NT-proBNP greater than 15pmol/L or NT-proBNP less than 15pmol/L with hsTnT greater than the 99th centile) will be seen for initiation/titration of ACE inhibitors/beta-blockers. Primary end point is the time to first event of death from any cause or cardiovascular readmission. The study will include 1770 patients at 3 centres in New Zealand, and follow up will be for 18 months.
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Trial website
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Trial related presentations / publications
Nil to date
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Public notes
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Contacts
Principal investigator
Name
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Prof Rob Doughty
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Address
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Heart Foundation Chair of Heart Health University of Auckland Dept of Medicine Park Road Grafton Auckland 1024 New Zealand
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Country
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New Zealand
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Phone
97106
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+64 9 9239804
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Fax
97106
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+64 9 377149
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Email
97106
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[email protected]
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Contact person for public queries
Name
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Rob Doughty
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Address
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Heart Foundation Chair of Heart Health University of Auckland Dept of Medicine Park Road Grafton Auckland 1024
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Country
97107
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New Zealand
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Phone
97107
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+64 9 9239804
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Fax
97107
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+64 9 377149
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Email
97107
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[email protected]
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Contact person for scientific queries
Name
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Rob Doughty
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Address
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Heart Foundation Chair of Heart Health University of Auckland Dept of Medicine Park Road Grafton Auckland 1024
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Country
97108
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New Zealand
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Phone
97108
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+64 9 9239804
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Fax
97108
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+64 9 377149
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Email
97108
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers in the same field can request data by contact with the PI
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
Baseline characteristics and clinical outcomes
What types of analyses could be done with individual participant data?
•
Available for appropriate meta-analyses addressing biomarker-guided risk management for patients with established CVD
When can requests for individual participant data be made (start and end dates)?
From:
On trial completion (2025), and no end date as yet determined
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Through contact with the PI, with contact information available in the ANZCTR record.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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