Every year, around 19,000 heart attacks and strokes occur within 90 days of a pneumonia hospitalisation in England alone. Pneumonia is the most common cause of unplanned hospital admission in the NHS, with roughly 270,000 emergency admissions annually, and it temporarily raises the risk of major cardiovascular events. Despite observational studies suggesting aspirin might protect against these events, no large randomised controlled trial has tested this. The ASPECT trial will recruit 22,600 patients over 50, giving half aspirin (150mg daily for 7 days, then 75mg daily up to 90 days) alongside standard care, and comparing outcomes against standard care alone. If aspirin reduces the risk by 15–20%, this would prevent an estimated 2,800 to 3,800 cardiovascular events each year in England alone. Because aspirin is cheap and widely available, a positive result could rapidly change treatment guidelines for pneumonia patients, reducing long-term disability and death without requiring expensive new infrastructure. The trial uses routine NHS data for follow-up, making it efficient and scalable.
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Research question: Does aspirin prescription reduce the risk of Major Adverse Cardiovascular Events (MACE) following emergency hospital admission with community acquired pneumonia? Background: Pneumonia is the commonest cause of unplanned hospital admissions worldwide with an estimated 270,000 emergency admissions to NHS hospitals in England every year. Pneumonia causes a short to medium term increased risk of major adverse cardiovascular events (MACE) such as myocardial infarction (MI) or stroke. Although observational studies exist suggesting a protective role for aspirin in preventing post-pneumonia MACE there have been no adequately powered randomised control trials (RCTs). Aims and objectives: To evaluate the effectiveness of aspirin versus usual standard care in preventing MACE in patients over 50 years old admitted to hospital with community-acquired pneumonia. The primary outcome is to estimate the difference between randomised groups in MACE within 90 days of randomisation. Secondary outcomes include the difference in all-cause mortality, cardiovascular mortality and major bleeding events up to 90 days. Methods: Multi-centre, open-label, parallel group RCT in 22,600 patients hospitalised with pneumonia, with internal pilot and efficient remote outcome measurement. Participants will be randomised to receive oral aspirin as 150mg once daily for 7 days (or until hospital discharge if sooner) followed by 75mg once daily up to 90 days. Follow-up will be facilitated by the remote collection of all outcome data from routine data sources: Hospital Episode Statistics Admitted Patient Care (HES-APC) and Office for National Statistics (ONS) mortality register, as opposed to additional follow-up visits. During the pilot phase of the trial the first 2000 participants will be contacted to assess adverse events which did not lead to hospitalisation and concordance with prescribed medication. Timelines for delivery: Total duration 48 months (m), comprising: set up (8m), internal pilot (12m), main trial recruitment (18m), additional follow-up (4m), analysis and reporting (6m). The pilot phase will conclude after the first 12 months recruitment (22 months after contract start) with progression criteria focused on recruitment, safety and MACE event rates. Anticipated impact and dissemination: Around 19,000 fatal and non-fatal MACE occur up to 90 days after admission with pneumonia in English hospitals annually, causing significant long-term morbidity and excess mortality. The high incidence of pneumonia means that there would be about 2,800-3,800 fewer MACE per year if aspirin were to reduce the risk by 15-20% (in England alone). Combined with the cost-effectiveness of aspirin the potential impact of this trial on health policy is very large. We will disseminate trial results on a dedicated trial webpage which will also be updated on progress and recruitment throughout the trial to inform participants and stakeholders. We will prepare press releases and communicate headline findings through social media channels. We will publish our results in medical journals and ensure they are rapidly incorporated into treatment guidelines, if appropriate, using established links with acute care, respiratory and primary care organisations.
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