How long did the ASPREE study run?
ASPREE started in March 2010 and formally concluded in January 2018. The trial followed the health of participants for an AVERAGE of 4.5 years. This means that people who joined the study in 2010 may have had seven annual ASPREE study visits, while those who enrolled in 2014 will have three year’s of annual visits. The ‘average’ time takes into consideration the time it has taken to recruit enough people into the study and ensured that everyone finished the study in the same year.
Had every ASPREE participant been followed for five years, we would have needed to wait until those enrolled in 2014, completed their time. That would make for an even longer study – the results wouldn’t be known until 2020!
When did participants find out which study tablet they were assigned?
The ASPREE study was a randomised double-blind study (some would say triple-blind) which ensured that for the duration of the study, the ASPREE team members, you, (and your GP), did not know which group (placebo or aspirin) you belonged to. This was done to ensure that there was no bias in the results from participants, study staff or GPs. Only in critical emergencies did we advise your doctor of which tablet you were taking.
You and your GP learned which arm of the trial you were in around the same time as publication of the main study paper in September 2018.
What happened at the end of the study?
ASPREE formally concluded in January 2018. Three major research papers were published in a prestigious, global medical journal, The New England Journal of Medicine in September 2018.
- Effect of Aspirin on Disability-free Survival in the Healthy Elderly (primary paper)
- Effect of Aspirin on All-Cause Mortality in the Healthy Elderly
- Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly
The study findings had been closely scrutinised by academic peers with relevant clinical expertise, as expected prior to publication in a high quality medical journal. ASPREE is the first large scale study in the world to consider the impact of disability on quality of life for older people. More information about the results can be found on the associated media release and FAQs. Additional research on the effect of aspirin on specific diseases, such as depression and cancer, will be published in future papers.
All ASPREE participants were invited to be involved in an important follow-up observational study, called ASPREE-XT (eXTension), to determine whether aspirin has a longer term effect on health, such as prevention of cancer or dementia. ASPREE-XT, which commenced in January 2018, will help also identify factors that may contribute to good or poor health in later years.
Why did you want to see me if I could not take study tablets during the trial?
Health information from all our participants was critical to the ASPREE study. Even if you had to stop taking study medication for medical reasons, your participation in study activity was still very important to the study.
ASPREE was an ‘intention to treat’ study, which means that all participants, even if they were not on any study medication, were included in the final analysis. Missing or incomplete data, diluted the accuracy of the results. An ‘intention to treat’ analysis enabled researchers to test the effectiveness of aspirin in real world scenarios, such as someone developing illness or being unable to take the study medication.
By continuing with annual visits you helped us learn about changes in health with and without aspirin during the trial period.
What are the phases of a clinical trial? What phase is the ASPREE study?
Most clinical drug trials are conducted in phases. The early phases of clinical trials typically involve a small number of participants to determine product safety and effectiveness. Later phases test the product in larger number of participants to collect more information on effectiveness, safety and possible side-effects.
ASPREE was a Phase IV study because the trial was conducted after a drug has been approved for use in human care. Phase IV studies collect more information about the intervention, such as: long term benefits and side effects in the wider community; human safety when the intervention is used in different conditions; and human safety when it is combined with other therapies.
ASPREE was a Phase IV study because the trial was conducted after a drug has been approved for use in human care. Phase IV studies collect more information about the intervention, such as: long term benefits and side effects in the wider community; human safety when the intervention is used in different conditions; and human safety when it is combined with other therapies.
Every phase in a clinical trial, does require approval from a Human Research Ethics Committee. Results from Phase IV studies can lead to new recommendations or withdrawal of an intervention from the market. For more information on different phases of a clinical trial see this post
What are ASPREE study updates and do I need to attend?
We have found study updates to be one of the most enjoyable aspects of the ASPREE trial. These informal events included a presentation on the progress of the trial and provided the opportunity to ask the research team questions.
As much as possible, we tried to hold study updates in central locations, close to public transport and/or with good car parking. You were sent an invitation to the nearest study update in the post. Attendance was completely voluntary and guests were welcome.
What dosage of aspirin was used in the trial and why?
‘Low-dose’ 100mg of enteric-coated aspirin was trialled in ASPREE. The enteric coating on the aspirin acts to reduce abdominal discomfort. Half of ASPREE participants were randomly assigned low-dose aspirin, the other half a matching placebo.
The 100mg dose of aspirin has blood thinning (anti-platelet) actions with low side effects from bleeding. This dose is lower than that usually taken for pain relief and for reducing fever. It is the same dose prescribed for people who need it for secondary prevention e.g. to prevent a second heart attack or stroke.
What was in the placebo and aspirin tablets?
The placebo was an ‘inactive’ tablet which looked identical to the ‘active’ aspirin tablet in size and shape.
Constituents of the placebo tablets:
- calcium hydrogen phosphate dehydrate
- cellulose (microcrystalline)
- citric acid anhydrous
- lactose monohydrate
- magnesium stearate
- maize starch and
- silica (colloidal anhydrous)
The placebo tablets, like the aspirin tablets, were enteric-coated.
The enteric-coating of both the placebo and aspirin tablets contained:
- methacrylicacid – ethylacrylate copolymer
- talc
- triethyl citrate (the enteric-coating of the aspirin tablets contained two additional ingredients: polysorbate 80 and sodium laurilsulfate)
The ‘active’ tablet contained 100 mg of acetylsalicylic acid (aspirin).
Are there any risks with taking aspirin?
All medications have the potential to cause adverse effects, and aspirin is no exception. Aspirin has risks related to its actions on chemicals in the body called prostaglandins and on platelets, a type of cell in the blood responsible for blood clotting.
Some prostaglandins cause fever, inflammation and pain, while other prostaglandins form a layer on the stomach wall to protect it from harsh stomach acid. Aspirin inhibits the production of prostaglandins, which will reduce fever, pain and inflammation, but it will also put the stomach at risk of this layer thinning. If the layer becomes too thin stomach acid can erode the wall of the stomach and form an ulcer.
Others side effects of aspirin are related to its action on platelets. Aspirin’s anti-platelet or blood thinning effect leads to a delay in blood clotting. This means that if you bleed and are taking aspirin, the bleeding may take longer to stop. Symptoms of this longer bleeding time may include bruises, blood in the stools (due to gastrointestinal bleeding), or in the worst case, a bleed into the brain (cerebral haemorrhage or a bleeding stroke). These adverse effects are risks. Although some people unfortunately experience side-effects, not everyone that takes aspirin will experiences adverse effects.
The balance of benefit and risks of aspirin in healthy older people were unknown prior to the ASPREE study. Your GP is the best person to give individual health advice on whether you should or should not take daily low-dose aspirin.
For more information about aspirin click here
Does aspirin react with other drugs?
Yes. Aspirin can interact with the following drugs: acetazolamide, corticosteroids, ibuprofen, probenecid, sodium valproate and warfarin. The significance of the interaction between aspirin and these medications varies depending upon the person taking them.
Aspirin belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). If you take a number of NSAIDs at the same time the side effects can be cumulative. If you have any concerns about any medications, please seek medical advice.
Who was eligible to be in the ASPREE study?
To enrol in the ASPREE trial participants needed to be:
- Aged 70 plus (No one was too old!)
- Able-bodied
- Without a history of a heart attack, stroke or a known bleeding risk
- Able to take aspirin or placebo tablet
- Able to undertake annual health checks
I know someone who was very interested in being in the ASPREE study. Is there another similar study?
We appreciate your friend’s interest in medical research.
A Monash University-led trial, which is currently recruiting older people, is the STAREE (STatins in Reducing Events in the Elderly) study. The randomised, placebo-controlled trial is investigating the balance of benefit versus the risk of cholesterol lowering medications (statins) in healthy older people. Participants need to be aged 70 and over, in good health and have no prior history of heart disease, stroke or diabetes. To find out more ring 1800 770 664 (toll free from a landline).
If your friend is interested in being involved in other future research projects run by Monash University, they are welcome to contact us on 1800 728 745 (toll free from a landline)
Did ASPREE include people with different cultural backgrounds?
Yes. We encouraged people of all different backgrounds to take part in the ASPREE study, provided that the individual could read and write in English. This is because all the forms and questionnaires are written in English.
Can’t find your question here? Contact the ASPREE team on 1800 728 745 (toll free from a landline) or email aspree@monash.edu