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Long-term study

What is the purpose of the ASCEND long-term study?

During the long-term follow-up phase of the study, we will collect data from central NHS registries. This will be used to assess whether the balance of benefits versus hazards of aspirin observed within the main trial, relating to major vascular events such as heart attack or stroke, continue long-term or whether additional benefits emerge during longer-term follow-up.

It had been suggested that low-dose aspirin might protect against cancer and ASCEND provides one of the first opportunities to test this hypothesis. The analyses based on the study treatment phase showed no reduction in any cancers during the (up to) 9 years of follow-up available so far. However, the main focus of the analyses will be after longer-term post-trial follow-up has been collected, when the study team will be much better position to assess whether there is any benefit.

Dementia and cognitive impairment are increasing globally with increasing lifespan. Diabetes is associated with an increased risk of developing these conditions and so the study team are investigating whether taking aspirin provides any benefit.

Diabetic retinopathy and diabetic maculopathy are among the most common causes of registerable blindness among working-age adults in the UK. The eye sub-study is assessing the impact of aspirin and omega-3 fatty acids on various eye outcomes including diabetic retinopathy, macular degeneration and cataracts by allowing linkage to diabetic screening registry information. Visual loss impacts significantly on the quality of life for those people affected, as well as generating financial costs to the NHS ophthalmology services. Therefore the preservation of vision is extremely important. This project will be part of a team member’s DPhil (being undertaken at the Nuffield Department of Population Health). The Macular Society has provided a grant to go towards the costs of this work.

The ASCEND work will also include two additional projects. One member of the team is undertaking a DPhil within the Nuffield Department of Population Health funded by the MRC Hubs for Trials Methodology Research (MRC HTMR). This project aims to investigate whether routine healthcare data can be used as the primary source of follow-up for clinical trials.

Another team member is undertaking an exploratory analysis of the effects of aspirin and omega-3 fatty acids on heart failure (HF) outcomes in ASCEND. The study also aims to develop streamlined methods of HF outcome ascertainment using routine healthcare data. This project is being undertaken within the Nuffield Department of Population Health in fulfilment of the academic requirements of a Doctor of Medicine degree registered at Warwick Medical School, University of Warwick.

The ASCEND trial and its sub-studies have been reviewed and approved by the North West – Haydock Research Ethics Committee (Ref: 03/8/087).

Who is doing the study?

The study is being conducted by researchers at the University of Oxford, which acts as the sponsor for the research.

Who is being included in the study?

The study includes participants of the original ASCEND study who have consented to being followed up long-term.

What information do you hold about me?

See our Privacy Notice for details of what information we may hold about you.

What will happen after the study treatment period finishes?

Information will continue to be gathered about you from NHS registries for many years beyond the end of the study treatment period so that any long-term effects of taking aspirin or fish oils can be discovered. If you do not wish to have further health information collected about you then you should inform the study team using the contact details in the Privacy Notice. Anonymised information about study participants, which would not identify you, may be shared in the future with other approved medical researchers. Sharing of information with other researchers helps ensure that research is open to scrutiny and that best use is made of the information collected. Researchers at Oxford University will remain responsible for the security and validity of the information held.

When will my participation in the study finish?

Your participation by taking study treatment in ASCEND finished during 2017. The results of the main ASCEND trial were published in 2018. We are continuing to collect information as described about hospital admissions and other outcomes of interest from NHS datasets, which will allow us to compare the long-term effects of the study medications. This extended follow-up is planned to continue until 2037.