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The University of Southampton

Frequently Asked Questions

What is a clinical trial?

Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to see if a new test or treatment works and is safe.  It may involve patients or healthy volunteers, or both.

Why are clinical trials important?

Before a treatment can be prescribed we need to know whether it works, whether it works better than other treatments currently used and if it has any side effects. These questions are usually answered by running a clinical trial of the treatment.

Trials are very carefully planned and regulated to protect the safety of anyone who takes part in them.  Without them, there is a risk that people will be given treatments that don’t work, or could even be dangerous.  Many NHS treatments have been tested in clinical trials.

What is a randomised control trial?

Not everyone receives a new treatment in a clinical trial, as we usually need to compare a new treatment with a standard treatment already in use, or with a ‘dummy’ treatment known as a ‘placebo’.  Standard care can be no specific treatment as in our control group in ATTACK.

In a randomised control trial, the treatment that a patient will receive is selected completely at random, by a process like flipping a coin.

What is the aim of the study?

The ATTACK study is designed to find out whether people with reduced kidney function (also known as chronic kidney disease or CKD) should take regular low-dose aspirin to reduce the chance of having a first heart attack or stroke. Heart attacks and strokes are more common in people with CKD than in the general population.

We also want to make sure that any benefits of taking aspirin are greater than the risk of bleeding, which is the most important side effect of aspirin.

Why was I chosen?

You have been invited because you have never had a heart attack or stroke but you have a blood or urine test results in your clinical record that suggests you have CKD (either reduced kidney function on a blood test or protein in the urine).

Is the trial testing a new treatment?

Aspirin is not a new treatment – low-dose aspirin is used widely in people who have already had a heart attack or stroke to prevent further events.  Aspirin is less beneficial in preventing a first attack or stroke in the general population and is generally not recommended for this purpose.  As heart attacks and strokes are far more common in people with CKD than in the general population, we would expect aspirin to be of greater benefit, but the risks may also be higher as bleeding is more common in people with reduced kidney function.  Before we can recommend aspirin treatment to help a first heart attack or stroke in people with CKD, we need to be sure that the benefits of treatment outweigh the possible risks.

If the ATTACK trial shows that the benefits of taking low-dose aspirin daily to prevent a heart attack or stroke are greater than the risk of bleeding, then aspirin can be offered widely to people with CKD.

Does the trial involve collecting samples of my cells or tissues?

The trial does not involve the collection of samples.

What are the benefits of taking part?

In many cases, you may get no direct benefit from taking part in clinical research, but the trial can provide vital information that will help people in the future.

Taking part in the ATTACK trial will give you contact with a research nurse and the opportunity to gain more information about CKD.

We also believe this trial, if successful, could lead to major cost savings for the NHS.

What are the risks?

When a clinical trial is designed, every effort is made to eliminate any risk to patients. For the ATTACK study, the only patients at risk of side effects will be those randomised to take aspirin. The major risk associated with aspirin is bleeding, particularly from the stomach and intestine.  This is discussed below under “Are there any possible side effects?”

If you decide to take part, it is important to tell us about any illnesses or changes in your body that you notice.

Is my information confidential?

Patient confidentiality is an essential requirement of clinical trials. All patient information collected in the ATTACK trial will be stored securely on a password-protected database situated within the NHS computer network.

What happens to my personal data when the trial ends?

At the end of the trial, data will be securely archived by the University of Southampton for a period of 10 years, as per clinical trial regulations, and then destroyed.

Who does the research?

The ATTACK study has been funded by a branch of the NHS called the National Institute for Health Research (NIHR) and also by the British Heart Foundation. The study has been organised by a team of medical doctors from different UK Hospitals and Universities and will be running all over the UK.

The study team will recruit GP practices who are interested in taking part in the study and suitable trial participants will be selected by their own GPs.

Will I see the results of the trial?

You will be informed when the trial is completed and a summary of the results will be sent to you. Results will also be published in scientific journals and presented at scientific meetings. Your details will remain strictly confidential and you will not be directly identifiable by name from any such report or publication.

Is my treatment affected if I don’t get involved?

Your treatment will not be affected in any way if you decide not to take part.

If I change my mind, can I leave the trial once I have started?

If you decide to take part, you will be free to withdraw from the trial at any time without giving a reason.

How long does the trial last and what will I have to do?

If you decide to take part, we will contact you by telephone to make just one appointment for a consent consultation. This will take place by telephone or video call to avoid the risk of Covid-19 transmission. Face-to-face appointment will only be made if national guidelines allow and this is preferred.

A research nurse will discuss the study with you and make sure that the study is suitable for you. You will also be able to ask questions about the study. If you are unsure whether to take part, you can ask to have another consultation or take longer to think about the study before making your decision.

If you are happy to join the study after this discussion, you will be asked to sign a consent form. The consent form confirms that you agree to take part and that you give us permission to look at your computerised medical records (now and in the future) from your GP and from any hospital you attend. Relevant sections of your medical records will be uploaded to the trial database to help with the trial’s analysis. We will ask you to post the signed consent form back to us in the pre-paid envelope provided.

After you have signed the consent form, we will ask some questions about your medical history and also ask you to complete a simple questionnaire.

If you are happy to continue you will be randomised either to carry on as usual, or be prescribed low-dose aspirin once a day in addition to your normal medication.

Once a year we will contact you and ask you to complete a questionnaire to let us know how you are getting on. There will be no further appointments to attend. We expect the trial to last between 3-6 years.

What will be different to the treatment or care I would normally receive?

If you are randomised to carry on as usual then there will be no difference to your normal care. If you are randomised to take a low-dose aspirin tablet once a day, this will be prescribed along with your usual medication.

Are there any possible side effects?

If you are asked to take aspirin, the most common side effects are indigestion and irritation of the stomach. Your GP may prescribe an additional medication to reduce it if necessary.

The most important side effect is bleeding, particularly from the stomach or intestine. Previous studies in people with CKD have shown that treatment with aspirin to help prevent heart disease may result in one extra serious bleeding episode per 500 people treated each year.

The most serious possible side-effect is bleeding into the brain.  This is rare, with 1-2 additional bleeds for every 10,000 people in the general population taking aspirin to prevent heart disease.

Some people may experience increased bruising.

The research nurse will be able to discuss this with you at the screening visit if you have any concerns.

Who can I talk to if I have any questions, concerns or problems?

The phone number of your local trial office is printed on the Patient Information Sheet and they will be happy to answer any questions you have about the trial.

If you have a complaint about any aspect of the trial, you can raise this through the NHS complaints procedure. Details can be obtained from your GP or local PALS (Patient Advice and Liaison Service).

Will I receive any payment for my time/travel expenses?

Participation in the trial is voluntary and you will not be paid for taking part, but we will reimburse you if you have to pay prescriptions charges for the trial medications.

What happens if I change my address or GP practice?

Please let your Regional Centre know if you change your address or GP practice. Their contact details can be found on the patient card that you were given at the consent visit or on the Participant Information Sheet.

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