All participants will be recruited to the trial by their GP practice.
Electronic searches of the GP practice clinical computer system will generate a list of people on the TIA/stroke register who meet the main inclusion criteria for the trial. This list will be reviewed by the local principal investigator (PI), the lead GP for the trial at the practice. The practice will then send invitation letters to those patients who are eligible, with a reply slip to return to the trial team at the University of Cambridge. The trial team will then send more information to patients interested in hearing more about the trial. If the patients are interested in taking part, an appointment will then be made for the first visit for the trial, at the GP practice
Potentially eligible participants will be sent an invitation letter for the trial (including reply slip and freepost return envelope) by the practice. In addition, PIs can also invite patients to the trial when they think they might be eligible for example during routine GP appointments.
Patients who respond expressing an interest in hearing more about the trial will receive the Patient Information Sheet, and will subsequently be invited to attend an appointment at their practice for the baseline visit. If they are unable to attend the practice, but are interested in taking part in the trial, they will be offered a home visit. Patients who do not respond to the initial invitation letter will be sent one reminder letter.
Participating in this trial is completely voluntary. If you decide to participate we will ask you to sign an Informed Consent Form (a document that participants must sign before participating in a clinical research study which provides participants with specific information about the study). However, you are still free to change your mind and leave the trial at any time without giving a reason. If you choose to leave the trial, your future medical treatment and normal standard of care will not be affected in any way.
What will happen to me if I take part?
You will either be started on Trinomia (and some or all of your medicines will be stopped), or you will carry on with what you are taking already. Which treatment you will be given is determined by a computer program using a chance process, much like flipping a coin. You will have a 50% chance of having Trinomia.
Throughout the duration of the trial, we would like to see you 4-6 times at the GP surgery (or at your home if you are unable to come to the surgery) over the course of 6 months.
These visits will last between 20 minutes and 1 ½ hours.
At 2-3 of these visits we will take a blood sample (about 5ml / 1 teaspoon). We will measure your blood pressure and ask you to fill out a questionnaire at most of the visits. If you need any help completing the questionnaire, we will be able to assist you.
For more details about the visits, please refer to the visit schedule.
What will I have to do if I decide to take part?
It is important that you take your medicines regularly as directed by the trial GP. We will ask you to carry a trial ID card with you at all times. This is so that any health care professional looking after you will know what treatment you are on.
What are the possible disadvantages and risks of taking part?
The risks of participating in this trial are low. If you are treated with Trinomia, the risk of side effects are likely to be similar to those of the medicines you are taking already.
What are the possible benefits of taking part?
Your risk factors for having another stroke may be better managed. In addition, your future care, and that of people like you may be better as a result of this trial.
What happens when the trial stops?
If you are taking Trinomia, at the end of this trial you will return to your usual care. Trinomia capsules will not be available after the trial has ended.
Expenses & Payment
You will not receive any payment for participating in this trial. However, we can reimburse any reasonable travel and parking costs you may incur as a result of taking part.
Who can I contact if I have any further questions?
You can contact us via email firstname.lastname@example.org, or you can phone us on 01223 763491.