FREQUENTLY ASKED QUESTIONS ABOUT ASPREE
Scroll down to find answers to common questions about the ASPREE study. To see frequently asked questions about aspirin click here.
If you haven’t found an answer to your question, please call the ASPREE Co-ordinating Centre on 1800 728 745 for a confidential discussion with one of our staff members.
Study Related Questions:
Eligibility:
Aspirin and Study Medications:
Study Related Answers
A low-dose form of aspirin is used in the ASPREE study. The dosage is 100mg of enteric-coated aspirin. The enteric coating on the aspirin acts to reduce abdominal discomfort.
What is in the placebo?
The placebo is an inactive tablet which looks identical to the aspirin tablet in size and shape. The 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 and triethyl citrate (the enteric coating of the aspirin tablets contains two additional ingredients: polysorbate 80 and sodium laurilsulfate).
The ASPREE study is a randomised double-blind study which ensures that for the duration of the study, neither ASPREE staff members, nor participants, nor the participant’s GP, know which group (placebo or aspirin) a participant belongs to. This is done to ensure that there is no bias in the results.
Participants in this study will need to travel to their local GP Clinic to attend the study visits. There is also an opportunity for participants to visit our clinical trial centre next to the Alfred Hospital if they wish. If participants choose to come to the Alfred Hospital, we are able to arrange reimbursement for car parking costs, and we also provide a pick-up and drop-off service for those who prefer to be transported.
In order to enrol in the study, participants are required to attend two baseline study visits with an ASPREE research staff member, scheduled approximately 4 weeks apart. At these two study visits, participants will have a range of measurements taken (blood pressure, height, weight, abdominal circumference), and will participate in a few tasks that involve thinking and memory, physical ability, lifestyle questionnaires and a hand grip strength test. These two visits normally take 1 hour each.
In the 4-week interval between the two study visits, participants visit their GP clinic, where they will have the opportunity to speak to their doctor about ASPREE. During this visit, the GP will also review the participant’s suitability for the study. After the second baseline study visit, participants will be randomised (randomly assigned by a computer system) to either low-dose aspirin or placebo, and will be sent their study medication in the mail.
Once randomised, participants will receive 3-monthly courtesy phone calls, and will attend Annual Visits with an ASPREE research staff member. The same series of measurements and assessments will be undertaken at these Annual Visits, as the initial two baseline study visits. For further details about the study visits, or the GP visit click here.
Yes. We encourage people of all different backgrounds to take part in the ASPREE study, provided that the individual can read and write in English. This is because all the forms and questionnaires are written in English.
Eligibility
Yes! Please call us on 1800 728 745 once you turn 70 years old. We will still be recruiting for the next twelve months.
Yes. For the ASPREE study, participants need to be 70 years or older, and there is no upper age limit.
Anyone who has experienced an allergic reaction to aspirin such as itchy skin, no matter how mild or severe, will not be eligible for the study.
A profoundly deaf person cannot enter the study – in order for a participant to be part of the study they must be able to hear instructions. It is not impossible for a visually impaired person to participate in the study, however it would be difficult, due to some of the visual components of the study’s primary thinking/memory questionnaire (the Modified Mini-Mental State Examination, or 3MS).
3MS performance is one of the factors that determines the participant’s eligibility for the study. Any participant who achieves a 3MS score within the study-defined limits, and who meets all the inclusion/exclusion criteria, no matter what visual aids are needed, can enter the study.
No. Those who have unfortunately had an event, such as a heart attack or stroke, require management for secondary prevention, or prevention of a second event. This may involve management by a specialist in addition to the GP and aspirin, or another anticoagulant medication may be prescribed as part of the treatment plan.
Cancer is not an exclusion factor per se. Your general practitioner can advise as to your suitability for ASPREE. Successful treatment of cancer usually means that a person is eligible.
Having a certain condition or disease does not automatically exclude you from the study. To ensure that the inclusion/exclusion criteria are met, we assess each condition/disease on a case-by-case basis in consultation with our medical team and your GP.
If you presently have a condition or disease and would like to discuss your eligibility for the study, please call our toll free number: 1800 728 745.
YES. If you are taking regular aspirin medication of your own volition, you must agree to stop taking your regular aspirin medication in order to enter the study. It is important to note that once you are an ASPREE participant, you will be randomly placed in either the placebo or aspirin group, i.e. there is no guarantee that you will assigned to the aspirin group.
If you are, however, taking prescription aspirin under the direction of your GP and you have met our eligibility criteria, you will need to confirm with your GP that it is appropriate for you to discontinue your current aspirin medication. The GP visit between the two baseline study visits provides an ideal opportunity for you to discuss these sorts of questions.
If you need to have surgery whilst participating in the study, you should notify your GP that you are a participant in the ASPREE study, with a 50% chance that you may be in the aspirin group. In an emergency situation, the treating physician/consultant physician should assume that you are taking aspirin.
It is important that we emphasise that ceasing study medication for a short period of time (e.g. in preparation for forthcoming surgery) is allowable in the study. You will also be encouraged to resume taking your study medication when your GP or surgeon advises it is safe to do so.
The decision as to whether or not to cease your study medication rests with your GP or physician. You are not automatically withdrawn from the ASPREE study if you need to have surgery, or if you need to come off the study medication (whether the cessation is temporary, or even if it is permanent). We do encourage you to resume taking the study medication with the approval of your GP.
However, regardless of your decision to continue with the study medication, we would still love to see you! We would ask that you remain in the study, attending all your scheduled Annual Visits with the ASPREE research staff.
Participants who develop conditions/disease during the course of the study will not be withdrawn. We fully recognise that some conditions will require the participant to cease their study medication (in some cases, this may be because they can’t risk being on aspirin, in other cases because they can’t risk NOT being on aspirin!).
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.
Aspirin and Study Medication
This is a dose that 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.
All medications have the potential to cause adverse effects, and aspirin is no exception. Aspirin has risks related to its actions on prostaglandins and platelets. In addition to causing fever, inflammation and pain prostaglandins form a layer on the stomach wall to protect it from harsh stomach acid. Aspirin inhibits the action of prostaglandins and hence there is a 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 are potentially bruises, blood in the stools (due to a stomach bleed), or in the worst case a bleed into the brain (cerebral haemorrhage or a bleeding stroke). These adverse effects are risks. Although some people do unfortunately experience them, not everyone that takes aspirin experiences adverse effects. For more information on the effects of aspirin click here.
From our initial studies we estimate that only 20% of abdominal pain experienced by study participants is actually due to aspirin. In the event that you experience stomach discomfort during your participation in the study, please notify your GP and seek their recommendation.
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 then re-challenge with study medication.
No. Even if you were to accidentally take 2 tablets in a given day, if your study medication is in fact aspirin, this would amount to 200mg aspirin, which is less than the standard 300mg dosage of many over-the-counter aspirin preparations (e.g. Disprin, Alka Seltzer). 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).
We also advise that you take your study medication 30 minutes before other medications, to minimise any drug interaction – see ‘Aspirin and Other Medications’ below. 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.
Yes. Aspirin is readily available over the counter and thus is considered a ‘safe’ drug. However, 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 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. For this reason, if you are taking regular NSAIDs we ask you to speak with your GP about being involved in the trial. Furthermore whilst in the ASPREE study, we advise that you take the study medication at least 30 minutes prior to other medications so that the effectiveness of study medication is maintained.
To see frequently asked questions about aspirin click here.