Could aspirin and fish oil help prevent heart attacks and stroke in diabetics?
Senior Cardiac Nurse Christopher Allen puts the questions to Professor Jane Armitage, Professor of Clinical Trials and Epidemiology at the University of Oxford.
Aspirin is commonly prescribed following a heart attack or stroke to reduce your risk of having another. It helps prevent blood clots that form when fatty plaques (atheroma) rupture in the arteries. Clots can disrupt blood flow to the heart or brain.
Contrary to some popular belief, healthy people should not take a daily aspirin because the risk of bleeding counterbalances any benefits. However, an ambitious BHF-funded clinical trial, led by Professor Jane Armitage from the University of Oxford, aims to discover whether people with diabetes could benefit from a small daily dose of aspirin. Their increased risk of heart attack and stroke means benefits may outweigh risks.
What the study consists of
Professor Armitage is studying 15,000 people with diabetes (type 1 and type 2) for seven years to see whether a daily dose of aspirin reduces their heart attack and stroke risk. The trial will also examine whether a fish oil supplement benefits people with diabetes.
This could have a huge impact and prevent many people dying
“Fish oil may have a small impact on reducing clotting and very small beneficial effects on cholesterol, but there is more uncertainty than with aspirin,” says Professor Armitage. “What this trial allows us to do, in a very neat way, is test two treatments at the same time in what is known as a 2x2 trial.”
Participants don’t know if they’re taking aspirin and the supplement, a placebo or a combination of the two. A quarter are receiving aspirin and a placebo fish oil, a quarter aspirin and fish oil, a quarter placebo aspirin and fish oil and the remaining quarter a placebo aspirin and placebo fish oil. Every six months, participants complete a questionnaire about their health, including whether they have had a heart attack or stroke during this time.
The study will follow people for seven years, on average, until 2017. “The response has been fantastic and we’d really like to thank everyone who is taking part,” says Professor Armitage.
She admits that keeping track of 15,000 people isn’t always easy. “We have a dedicated admin team who work tirelessly, keeping things ticking over day to day,” she says.
“The biggest part of their job is translating all of the data and information that comes in via the questionnaires and making sure this is all entered correctly into IT programs that can analyse the data.”
Support from the BHF to fund the trial
The BHF has provided £3.9m to fund the trial. “When you’re carrying out research into the effect of older drugs that are no longer under patent, it’s incredibly difficult to get any funding from drug companies,” explains Professor Armitage. “Without the BHF, we may not have been able to carry out this research to the high standards we’re currently working at. Your supporters are helping us to answer a very important question.”
Without the BHF, we may not have been able to carry out this research to the high standards
The bulk of the funding pays for staff managing the trial. “As well as our admin team, who handle the questionnaires and data input, we have a further two senior administrators responsible for the overall running of the study.
“Associate Professor Dr Louise Bowman and I have joint clinical and overall responsibility alongside the other doctors and nurses involved in the running of all other aspects of the trial,” says Professor Armitage.
“We also offer our participants a dedicated 24-hour free phone service for any questions they have or information they need to give us. These queries are dealt with by different members of the team.”
While trial costs are significant, the result could be a low-cost, life saving solution. “Aspirin is cheap and easy to take, and if we can show clearly that benefits outweigh risks, then a very general recommendation can be made that people with diabetes should take a daily aspirin,” says Professor Armitage.
“This could have a huge impact and prevent many people dying or having a heart attack or stroke.”
CV Professor Jane Armitage
- Professor of Clinical Trials and Epidemiology at the University of Oxford
- Honorary Consultant in Public Health Medicine in the Nuffield Department of Population Health (NDPH)
- Co-ordinates large-scale clinical trials including the MRC/BHF Heart Protection Study, SEARCH and HPS2-THRIVE
- Main research interests are lipids and the epidemiology of cardiovascular and other chronic disease, including osteoporosis