IMPACT: A clinical trial evaluating if polypill-based care improves adherence, blood pressure & cholesterol in people at high cardiovascular risk

IMPACT: A clinical trial evaluation if polypill-based care improves adherence, blood pressure and cholesterol in people at high cardiovascular risk


Rationale

Cardiovascular disease is NZ's biggest killer and leading cause of loss of healthy life years. Maori are disproportionately affected and cardiovascular disease is the main reason for the increasing difference in life expectancy between Maori and non Maori. Reducing cardiovascular disease and removing these inequalities will require extensive public health strategies.


One approach, which could achieve substantial benefits within a few years, is fixed-dose combination medication (a "polypill"). The polypill has the potential to address the current treatment gap for individuals at high risk of cardiovascular disease, and to improve the utilisation of long-term preventive therapies consistent with guideline recommendations.


Aims

The primary aim of the study is to assess whether provision of combination cardiovascular medication (a "polypill") compared to continuing usual cardiovascular medications improves clinical outcomes in high-risk patients by increasing adherence to guideline recommended therapy; and to assess whether results are similar for Maori and non-Maori.


Design

This is an open label, randomised, controlled trial. 600 participants (including 300 Maori) at high risk of cardiovascular disease will be recruited through primary care. Participants will be randomised to the polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) or to usual care (cardiovascular medication as prescribed by their general practitioner) and followed for one year. The primary outcomes are adherence, and change in blood pressure and cholesterol levels.

Funding

Health Research Council of New Zealand

CTRU Investigators

  • Anthony Rodgers, Principal Investigator
  • Valery Feigin
  • Natasha Rafter
  • Vanessa Selak
  • Stephen Vander Hoorn
  • Puti Wilson

Collaborators

  • Bruce Arroll, General Practice & Primary Health Care, University of Auckland;
  • Dale Bramley, Waitemata DHB;
  • Jennie Connor, Rod Jackson, and Richard Milne, Epidemiology & Biostatistics, University of Auckland;
  • Rob Cook, Bazian Ltd, London, UK;
  • Sue Crengle, Maori Health, University of Auckland;
  • Rob Doughty, Auckland DHB;
  • Tim Maling, Capital & Coast DHB;
  • Bruce Neal, The George Institute for International Health, Sydney, Australia;
  • Anushka Patel, The George Institute for International Health, Sydney, Australia;
  • David Simmons, Institute of Metabolic Sciences, University of Cambridge, UK.