How long did the ASPREE study run?
The ASPREE 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 7 annual ASPREE study visits, while those who enrolled in 2014 will have 3 year’s of annual visits. The ‘average’ time takes into consideration the time it has taken to recruit enough people into the study and ensures that everyone finishes the study in the same year.
Since 2010, ASPREE has continued to expand and grow in size and complexity, which has increased the recruitment time to 4 years, but it will also provide more detailed findings at the end of the study.
An alternative model is that if each ASPREE participant could be followed for 5 years, we would need 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!
Do I find out if I am in the aspirin or placebo group during the study?
The ASPREE study is a randomised double-blind study (some would say triple-blind) which ensures that for the duration of the study, the ASPREE staff members, you, (and your GP), will not know which group (placebo or aspirin) you belong to. This is done to ensure that there is no bias in the results from participants, study staff or GPs.
Only in critical emergencies did we advise your doctor of which tablet you are taking. In an emergency situation, the treating physician/consultant physician should assume that you are taking aspirin.
You and your GP will learn which arm of the trial you were in around the same time as publication of the primary paper.
What happens at the end of the study?
What we call the ‘primary’ paper is expected to be published in a prestigious, global medical journal mid 2018. The study findings, which will be scrutinised by academic peers, will formally answer ASPREE’s main question: does daily low dose aspirin prolong life, free from dementia and persistent physical disability? ASPREE is the first large scale study in the world to consider the impact of disability on quality of life for older people. This main paper will also determine the overall benefit versus the risk of low dose aspirin for disease prevention in healthy older people.
Additional research on the effect of aspirin on specific diseases, such as cardiovascular disease and depression, will be published in future papers.
Around the time of publication of the primary paper this year, you and your GP will be notified which study tablet you were taking – aspirin or the placebo – and be given a summary of your ASPREE journey.
Additional research on the effect of aspirin on specific diseases, such as cardiovascular disease and depression, will be published in future papers.
Around the time of publication of the primary paper this year, you and your GP will be notified which study tablet you were taking – aspirin or the placebo – and be given a summary of your ASPREE journey.
No individual participants can be identified from any of the reports.
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 is an ‘intention to treat’ study, which means that all participants, even if they are not on any study medication, are included in the final analysis. Missing or incomplete data, dilutes the accuracy of the results. An ‘intention to treat’ analysis allows for 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. We greatly appreciated your ongoing participation in the study.
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 is 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 is 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 try to hold study updates in central locations, close to public transport and/or with good car parking. You will be sent an invitation to the nearest study update in the post. Attendance is completely voluntary and you are most welcome to bring a guest.
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.
Study medication was well tolerated by most people. However, we advised all our participants to discuss any concerns about study tablets with their GP.
What was in the placebo and aspirin tablets?
The placebo is an ‘inactive’ tablet which looks identical to the ‘active’ aspirin tablet in size and shape.
Constituents of the placebo tablets are:
- 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, are enteric-coated.
The enteric-coating of both the placebo and aspirin tablets contains:
- methacrylicacid – ethylacrylate copolymer
- talc
- triethyl citrate (the enteric-coating of the aspirin tablets contains two additional ingredients: polysorbate 80 and sodium laurilsulfate)
The ‘active’ tablet contains 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.
For more information about aspirin click here
Does aspirin react with other drugs?
Yes. While aspirin is considered a ‘safe’ drug and is readily available over the counter, it 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. If you are on any of these medications and have a question about whether or not you should take aspirin ASPREE recommends that you speak with your GP.
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
- Recruitment for the ASPREE study has now closed
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