What do I do now I am part of the study?
All participants will have been randomly assigned (by a computer system) to either low-dose aspirin or a placebo tablet to take every day. You will receive a courtesy phone call approximately every three months lasting between 2 and 10 minutes. We also ask you to attend an annual study visit with an ASPREE research staff member.
Measurements and assessments will be undertaken at these annual visits, similar to the baseline study visits conducted when you enrolled in the trial. To see a summary of study visits, click here.
Where do I attend annual study visits?
Most participants in this study travel to their local ASPREE study site to attend the study visits.
How long will I be in the ASPREE study?
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. Using the ‘average’ 5 year participation in the trial means the results should be available in 2018.
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!
Am I able to find out if I am in the aspirin or placebo group during the study?
Only in critical emergencies can 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.
At the end of 2017, we will break the code enabling you and your provider to learn which arm of the trial you were in.
What happens at the end of the study?
If I need to have surgery while I am in the study, do I have to come off the study medication?
Ceasing study medication for a short period of time (e.g. in preparation for forthcoming surgery) is allowable in the study. Please resume taking your study medication as soon as your doctor or surgeon advises it is safe to do so.
The decision to cease your study medication for medical reasons rests with your provider or physician. If you need to come off the study medication (whether the cessation is temporary, such as for surgery, or even if it is permanent) you are still a very important to the ASPREE study.
Can I be in the study and take aspirin during extended travels?
ASPREE study medications consist of 100mg aspirin or a placebo. For the purposes of travel, there are two options: participants could take 100 mg of aspirin in addition to study medication (meaning participants would be taking between 100 mg or 200 mg aspirin daily) OR they could stop study medication for this period and take 100 mg aspirin only. If you do stop study medication temporarily, we ask that you resume as soon as possible after completion of the travel.
If I develop a condition during the study, such as a stomach ulcer, does that rule me out of the study?
ASPREE has been designed on an intention-to-treat basis – this means that, regardless of whether or not you continue taking your study medication, we will seek to follow your progress for the duration of the study as your health information will help complete the ASPREE study.
Why do you still want to see me if I can no longer take study medication?
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.
If you are no longer able to take study mediation, by continuing with annual visits you will help us learn about changes in health with and without aspirin. We greatly appreciate your ongoing participation in the study.
What am I to make of aspirin stories I've read or seen on TV?
Aspirin is such a commonly used drug, it often attracts mainstream press. Journalists rarely have the space or time to write in-depth stories about aspirin or to report the limitations of a new study (e.g., the type of study, the age of the participants and the dose and duration of aspirin use.) For this reason, ASPREE will often issue a statement in the ‘news’ section of this website in response to an aspirin study and sometimes we may send you a letter explaining the research.
If you do have any concerns about a media report, please contact your study staff.
A team of highly experienced doctors, scientists and researchers monitor aspirin studies and will notify you should there be any concerns.
As required by government health agencies, we also have an independent international committee of specialists dedicated to monitoring ASPREE study data. If there is a likelihood of overall harm, the study will be stopped immediately.
What dosage of aspirin is used in the trial and why?
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, i.e., to prevent a second heart attack or stroke.
Study medication is well tolerated by most people. However, we advise all our participants to discuss any concerns about study medication with their provider or ASPREE study staff.
What is in the placebo and aspirin tablets?
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
- 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?
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 hemorrhage 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.
ASPREE is the first study in the world to determine the balance of the benefit of aspirin versus the risk of side-effects in healthy older people.
Does aspirin react with other drugs?
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. For this reason, if you are taking regular NSAIDs we ask you to speak with your provider about their use and potential alternatives.
If I have forgotten that I have already taken the study medication in the morning, and I take another tablet later in the day, could I give myself an overdose?
However, we do recommend that you take your study medication at the same time each day, so that you develop a routine (thereby minimizing the chances of taking more than one tablet per day).
If you discover that you have missed taking your study medication on a given day, take the missed tablet as soon as possible that same day.
Is it safe to take aspirin with my cholesterol lowering medication and blood pressure medication?
If I experience stomach discomfort during the study, can I take medication to counteract the discomfort?
It may be appropriate for you to cease your study medication temporarily (it may be aspirin or it may be placebo) to see whether the stomach discomfort or other adverse effect subsides, and if it doesn’t, then the discomfort is most likely not due to the study medication. It would then be appropriate to try study medication again, which is called a ‘re-challenge’.
I take paracetamol, is that the same as aspirin? Is it OK to take paracetamol and my study medication at the same time?
However, we do recommend that you take your study medication at the same time each day, so that you develop a routine (thereby minimising the chances of taking more than one tablet per day).
When will I know which tablet I've been on?
Who was eligible to be in the ASPREE study?
- Aged 65 plus (No one was too old!)
- Male or female
- 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.