FAQs

You will receive information and be asked to sign a consent form. If you decide to take part in ASPIRING then one of the study team at your hospital will show you an ASPIRING information video and go through an information sheet with you and answer any questions you have. If you agree to take part, we will ask you to sign a consent form. We will give you a copy of this signed consent form and the participant information sheet either in person or we can email them to you. Whatever you decide about taking part, you will receive the same standard medical care in addition to the study medicine, if you are allocated to take it.

Collection of information about you and your medical history: One of the study team will then ask you some simple questions about your health and collect some information from your medical records. They will record your contact details and the contact details of the close personal contacts you identify who have agreed to provide information about how you get on; we may need to use these if new safety information becomes available, or the study is stopped. Everyone registered with a GP has their own unique number. This is known as a CHI number in Scotland and an NHS number in the rest of the UK. We will collect your CHI/NHS number because it helps us to identify you correctly for follow-up.

Random allocation to treatment: Randomised studies are the fairest tests of treatment because the process of randomly allocating each patient to a group makes the groups very similar, so that it is fair to compare them to see which one does better. The chance of being in either group is equal, or 50%, also known as “50:50”. You are as likely to be assigned to starting aspirin or clopidogrel as you are to be assigned to not take antiplatelet medicines.  

In ASPIRING, your study team sends some information about you in confidence to the ASPIRING coordinating centre in Edinburgh; and the computer system randomly allocates you to a policy of either starting aspirin or clopidogrel or not starting antiplatelet medicines. You will know which treatment you are allocated to. If you are allocated to start aspirin or clopidogrel, you will be prescribed the drug chosen by your hospital consultant to start within one day as a daily tablet that you take by mouth. They will write to your general practitioner (GP) and other doctors caring for you to let them know that you are taking part, so that they will continue the treatment that the study has allocated you to until the end of the study.  

Checking how you get on in the future: The study needs to know how you get on so that it can work out which treatment group is best but you will not need to come back to hospital.  

When you leave the hospital, or move to a rehabilitation unit, the doctors at your hospital will send the ASPIRING study coordinating centre information about your health and where you are moving to. ASPIRING will keep an eye on your progress by receiving information about hospital admissions, drug prescriptions, drug dispensing, death records and other data held by NHS bodies such as NHS England that could help us work out whether starting or avoiding antiplatelet medicine is best.  

There will be no additional appointments for you to attend or forms/ questionnaires for you to fill in, we will obtain all the information we need to monitor your progress from your healthcare providers, so you don’t have to do anything.  

We intend to follow every person in the study for between one and five years until the end of the study. We will store this information securely and confidentially at The University of Edinburgh for 5 years after the end of the study. 

No, it is up to you to decide whether or not to take part. If you decide to take part, we will give you an information sheet to keep and we will ask you to sign a consent form. You can give your consent by telephone or video call at a later date if that’s easier for you. If you decide to take part, you are still free to withdraw at any time and without giving a reason. Deciding not to take part or withdrawing from the study will not affect the healthcare that you receive, or your legal rights. 

The study team will explain that aspirin and clopidogrel reduce the risk of clotting.  

The results from this study may help to improve the healthcare of patients in the future. 

Disadvantages of medicines in standard practice: The study team will explain that the risks of the antiplatelet medicines used in ASPIRING are the same as in standard practice. The common side effects of aspirin are an increased bleeding tendency and indigestion. The common side effect of clopidogrel is an increased bleeding tendency.

Disadvantages of the study: You may find the time you spend taking part inconvenient. Before deciding to take part, you should consider if this will affect any insurance you have and seek advice if necessary. Taking part in clinical research may affect the insurance cover you get (e.g. travel insurance, life insurance, critical illness cover). Before taking part, seek advice if you need it.

Yes. All the information we collect during the course of the research will be kept confidential and there are strict laws which safeguard your privacy at every stage.

ASPIRING is run by a team at the University of Edinburgh who take care to protect your information. The information is processed and protected by this team. The team includes medical, computing and administrative staff, all of whom have a duty of confidentiality to you. Identifiable information about you will be sent in confidence via secure NHS networks to the ASPIRING coordinating centre in Edinburgh. Identifiable data about you, described below, will be kept in a separate part of the study database from your health information.  

Your information (your personal data) will be stored securely in a study database on servers, which are securely hosted by the University of Edinburgh. The database will be compliant with the relevant regulations and Sponsor Standard Operating Procedures. Only trained and approved members of the study team will be given password-protected access to the study database. We comply with the GDPR and Data Protection Act 2018 and Caldicott principles when sharing or processing your data within the NHS and other organisations involved in the study. The University of Edinburgh/NHS Lothian is the data controller. 

If you decide to withdraw, please contact your study team. ASPIRING will retain information collected about you before the time you withdrew. Deciding not to take part or withdrawing from the study will not affect the healthcare that you receive, or your legal rights.

The University of Edinburgh and NHS Lothian sponsor the study. The British Heart Foundation fund the conduct of ASPIRING by a grant to the University of Edinburgh. Professor Rustam Salman is the Chief Investigator in charge of the study. 

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given a favourable opinion by the Scotland A Research Ethics Committee. All participants are covered by The University of Edinburgh’s insurance policy, which needs to be in place before the study starts.

In designing this study, we have taken into account patients’ opinions on what’s involved in the study. The Research to Understand Stroke due to Haemorrhage (RUSH) patient reference group, and other patients, have reviewed and commented upon this participant information leaflet.

• Email: Loth.ASPIRING@nhs.scot
• Telephone: 0131 537 2944

You will not be paid for taking part. You also won’t benefit financially if study results/data are exploited for commercial gain.