FREQUENTLY ASKED QUESTIONS ABOUT ASPREE

Now that we have finished recruitment, we move into the observation stage of the trial.

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.

Most participants in this study travel to their local GP clinic to attend the study visits.  Sometimes, a medical clinic will not have a spare room available for study visits. If this happens we will arrange to conduct study visits at an alternative venue that maintains your privacy and is close to where you live.

Participants are also welcome to attend an annual visit at our clinical trial centres.

If you are having difficulties with transportation to a study visit, please do contact our team.

The ASPREE trial will follow the health of participants for an AVERAGE of five 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.  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!

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 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 GP to learn which arm of the trial you were in.

When the study finishes, you and your GP will be informed of the results and which arm of the study you have been in (aspirin or placebo) throughout the trial. We will also publish study findings in professional medical journals and mainstream press. No individual participants can be identified from any of the reports.

If you need to have surgery whilst participating in the study, you should notify your doctor 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.

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 GP or surgeon advises it is safe to do so, and notify the ASPREE team on 1800 728 745.

The decision to cease your study medication for medical reasons rests with your GP or physician. If you need to come off the study medication for any reason (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.

Yes, it is possible to take aspirin temporarily for travel purposes. However, because there is no trial evidence that aspirin prevents DVTs in travellers, we strongly recommend that the decision as to whether or not to take aspirin during travel should be on advice of your doctor.

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.

We are happy to provide a ‘travel’ letter about the study medication if you wish to take study medication while overseas. To request a ‘travel’ letter, call 1800 728 745 or email aspree@monash.edu.

Participants who develop conditions/disease stay in the study. 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 are taken off study medication for medical reasons, we follow your health for the duration of the study.  Your health information will help complete the ASPREE study.

Health information from all our participants is critical to the ASPREE study. Even if you have had to stop taking study medication for medical reasons, you are 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.

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.

Hundreds of papers about aspirin are published every year. While these studies are of interest, the findings are often only preliminary and not relevant to healthy older people.  In fact many aspirin studies published in scientific journals recommend further investigation by large clinical trials such as ASPREE to provide conclusive evidence.

Aspirin is such a commonly used drug, it often attracts mainstream press. Journalists rarely have the space or time to write indepth 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 us on 1800 728 745.

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.

Most clinical drug trials 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 is being 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

 

We have found study updates to be one of the most enjoyable aspects of the ASPREE trial. These informal events include a presentation on the progress of the trial and provide the opportunity to ask the research team questions. Afterwards, feel free to join ASPREE staff and fellow participants for a cuppa.

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.

‘Low-dose’ 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. Half of ASPREE participants have been randomly assigned this 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 is well tolerated by most people. However, we advise all our participants to discuss any concerns about study medication with their GP.

Participants are given twelve month’s supply of study medication at Visit 2 then at each annual visit. Sometimes annual study visits are unavoidably delayed, such as when a participant travels.

If you find you may not have enough study medication to last you until your next annual visit, please contact us on 1800 728 745 (toll free from a landline) and we’ll arrange for an exchange with new 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).

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.

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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.

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.

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. For this reason, if you are taking regular NSAIDs we ask you to speak with your GP about their use and potential alternatives.

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).

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.

We can provide a pill box with daily compartments to hold your study medication (and any other medications). If you would like one, please call 1800 728 745 or speak to an ASPREE staff member at your next study visit.

Yes. We recommend that you take your study medication at the same time each day, so that you develop a routine.

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 his/her 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 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’.

Paracetamol and aspirin are two different classes of drugs. The study medication is either enteric-coated 100mg of aspirin or a matching placebo (dummy tablet), either of which can be taken at the same time as paracetamol.

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 anticipate being able to advise you which arm of the study you have been in by the end of 2017.
Thank you for your ongoing commitment to medical research for the duration of this 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.

We appreciate your friend’s interest in medical research, however recruitment into the ASPREE study has now closed.

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).

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.