CompletedPhase 4ACTRN12618002005235

Biomarker-Guided Risk Management for Secondary Prevention following Acute Coronary Syndromes: a Feasibility Study


Sponsor

Professor Rob Doughty

Enrollment

100 participants

Start Date

Dec 3, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • primary diagnosis of acute coronary syndrome
  • Age >18 years

Exclusion Criteria4

  • 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)

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Interventions

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 grou

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


Locations(1)

Auckland, New Zealand

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ACTRN12618002005235