Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002005235
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Biomarker-Guided Risk Management for Secondary Prevention following Acute Coronary Syndromes: a Feasibility Study
Scientific title
Biomarker-Guided Risk Management for Secondary Prevention following Acute Coronary Syndromes: a Feasibility Study
Secondary ID [1] 296831 0
Nil
Universal Trial Number (UTN)
U1111-1220-7638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary prevention post-acute coronary syndrome 310732 0
cardiovascular disease 310733 0
Condition category
Condition code
Cardiovascular 309424 309424 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be seen between 1 and 6 months post hospital discharge for ACS, and have a baseline assessment. The patients will have NT-proBNP measured, for those patients in the intervention group if the NT-proBNP is above 15pmol/L then the patients 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 3 months post-enrolment
Adherence will be discussed with the patients at every visit but other specific strategies will not be utilised in this feasibility study
Intervention code [1] 313115 0
Treatment: Drugs
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 NT-proBNP 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.
Control group
Active

Outcomes
Primary outcome [1] 308379 0
Maximum tolerated dosages of ACEI/ARB and beta-blocker (composite outcome)
This is assessed by review of the dispensed medications up to the 3 month post-enrolment visit. These are available on the electronic medical record, the class of drugs and the medication dosages will be available and recorded for this study. These will be checked at the clinic visits with the patients.
Timepoint [1] 308379 0
3 months post-enrolment
Secondary outcome [1] 354812 0
Number of clinic visits needed to achieve dose titration within 3 months of the enrolment
These are assessed using the clinical records
Timepoint [1] 354812 0
3 months post-enrolment
Secondary outcome [2] 354855 0
Assessment of methods for enrolment - this is a qualitative assessment of the processes involved with recruitment through the hospital clinics, cardiac rehabilitation services and primary care
These will be assessed using one-on-one interviews with the healthcare providers in the clinics, cardiac rehabilitation services and primary care physicians
Timepoint [2] 354855 0
3 months post enrolment

Eligibility
Key inclusion criteria
primary diagnosis of acute coronary syndrome
Age >18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Left ventricular ejection fraction (LVEF) < 35%
Severe aortic stenosis
other life-limiting disease (life expectancy<1 year),
end-stage renal disease (defined as eGFR < 15ml/min)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this end point is based on maximum dosages of these drugs in 50% of the NT-proBNP group compared with 20% of usual care group: 95 patients are required, with 2:1 randomisation (32 usual care and 63 biomarker group: 100 patients in total to allow 5% drop-out).
The proportions with maximum medication dosages will be compared using standard statistical techniques in the statistical software "R"

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/12/2018
Actual
Date of last participant enrolment
Anticipated
26/04/2019
Actual
Date of last data collection
Anticipated
30/08/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 21112 0
New Zealand
State/province [1] 21112 0
Auckland

Funding & Sponsors
Funding source category [1] 301404 0
Other Collaborative groups
Name [1] 301404 0
Auckland Academic Health Alliance
Country [1] 301404 0
New Zealand
Funding source category [2] 301405 0
Charities/Societies/Foundations
Name [2] 301405 0
Heart Foundation of New Zealand
Country [2] 301405 0
New Zealand
Primary sponsor type
Individual
Name
Professor Rob Doughty
Address
University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 301081 0
None
Name [1] 301081 0
Address [1] 301081 0
Country [1] 301081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302141 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 302141 0
Ministry of Health, 133 Molesworth Street, Wellington, 6011
Ethics committee country [1] 302141 0
New Zealand
Date submitted for ethics approval [1] 302141 0
28/09/2018
Approval date [1] 302141 0
19/10/2018
Ethics approval number [1] 302141 0
18/STH/190

Summary
Brief summary
Background. Recurrent clinical events remain common among patients following acute coronary syndromes and there is thus a need to improve secondary prevention to reduce clinical outcomes. Brain natriuretic peptide (NT-proBNP) is a predictor of outcome, independent of standard clinical risk factors, in patients with established cardiovascular disease. Initial studies suggest the potential for intensified renin-angiotensin antagonist/beta-blocker therapy in patients with elevated NT-proBNP to improve clinical outcomes in patients with cardiovascular disease.

Aim. The aim of this is to develop the infrastructure to support a sustainable process to deliver a large-scale randomised controlled trial in primary care of a biomarker guided approach for long-term secondary prevention for people following hospitalisation for acute coronary syndromes in NZ.

Methods. This feasibility study will assess a number of key pathways that need to be established and tested to ensure a large scale randomised controlled trial can be successfully implemented in the NZ healthcare setting. The study will include 100 patients with recent ACS, randomised 2:1 to NT-proBNP and usual care groups. The study primary end point will be the proportion of patients achieving the maximum tolerated medications and secondary end-points will include assessment of the number of clinic visits required to titrate the medications following randomisation and qualitative assessment of the methods for enrolment of the patients for this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89258 0
Prof Rob Doughty
Address 89258 0
Dept of Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand
Country 89258 0
New Zealand
Phone 89258 0
+6499239804
Fax 89258 0
Email 89258 0
r.doughty@auckland.ac.nz
Contact person for public queries
Name 89259 0
Prof Rob Doughty
Address 89259 0
Dept of Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand
Country 89259 0
New Zealand
Phone 89259 0
+6499239804
Fax 89259 0
Email 89259 0
r.doughty@auckland.ac.nz
Contact person for scientific queries
Name 89260 0
Prof Rob Doughty
Address 89260 0
Dept of Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand
Country 89260 0
New Zealand
Phone 89260 0
+6499239804
Fax 89260 0
Email 89260 0
r.doughty@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study designed to inform the development of a larger clinical trial and thus the individual data are specific to this stage of the trial development


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.