A clinical research network would facilitate routinely including primary care patients in large clinical trials
Although aspirin‐containing medications prevent cardiovascular events,1 meta‐analyses of randomised trials have found that, overall, they do more harm than good when used for primary prevention.2 The recently published ASPREE trial3,4,5 confirmed that this holds true for older people without cardiovascular disease, dementia or physical disability. The well conducted trial — with 19 114 participants, the largest ever undertaken in Australia — found no benefit for treatment with low dose aspirin (compared with placebo) in terms of disability‐free survival,3 cardiovascular disease4 or fatal cancer.5 However, there was evidence of harm, with an increased risk of death and bleeding among participants receiving aspirin.4,5
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- 2. Seshasai SR, Wijesuriya S, Sivakumaran R, et al. Effect of aspirin on vascular and nonvascular outcomes: meta‐analysis of randomized controlled trials. Arch Intern Med 2012; 172: 209–216.
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- 7. Piepoli MF, Hoes AW, Agewall S, et al. 2016 European guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2016; 37: 2315–2381.
- 8. The ASPREE Investigators. ASPirin in Reducing Events in the Elderly: protocol, v9.0. Nov 2014. https://aspree.org/usa/wp-content/uploads/sites/3/2014/04/ASPREE-Protocol-Version-9_-Nov2014_FINAL.pdf (viewed Jan 2019).
- 9. Lockery JE, Collyer TA, Abhayaratna WP, et al. Recruiting general practice patients for large clinical trials: lessons from the Aspirin in Reducing Events in the Elderly (ASPREE) study. Med J Aust 2019; 210: 000–000.
- 10. Butler CC, Connor JT, Lewis RJ, et al. Answering patient‐centred questions efficiently: response‐adaptive platform trials in primary care. Br J Gen Pract 2018; 68: 294–295.
- 11. Gulliford MC, van Staa TP, McDermott L, et al. Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study). Trials 2014; 15: 220.
James Sheppard receives funding from the Wellcome Trust/Royal Society (Sir Henry Dale Fellowship, 211182/Z/18/Z). Chris Butler is a National Institute for Health Research (NIHR) Senior Investigator.
No relevant disclosures.