At the first visit, you will see a nurse who will check that you understand what taking part in the trial means. If you agree to participate in the trial, we will ask you to sign the Informed Consent Form, a document which provides participants with specific information about the study. We will give you a copy of this to take away and refer to later. The nurse will ask you about your medical history, and measure your blood pressure.
Using this information they can determine whether you are likely to be eligible to take part in the trial. Next they will take a sample of blood and ask you to fill in a questionnaire about your general health and lifestyle. The visit should take about 1 1/2 hours.
The GP will look at the results of the tests to decide whether you can take part in the trial.
We will send you a letter confirming which treatment you will be taking during the trial – Trinomia or your usual medication.
If you are going to be taking Trinomia, you will receive a package containing the capsules in the post. But you must not start taking these until you see the GP at your next visit (visit 2). We may also contact you by telephone to confirm that the Trinomia capsules have been delivered safely in the post.
Your second visit will be approximately 2 weeks after your visit 1. You will see the GP who will discuss with you what medicines you need to take for the duration of the trial and how to take these. This visit should take about 15 minutes.
At the third visit, which is approximately 2 weeks after your visit 2, we will measure your blood pressure, check your medication with you and ask you to fill in a questionnaire about your general health and lifestyle. You will need to bring all your heart/stroke medication, or your Trinomia capsules with you to this visit. If you are taking Trinomia we will also take a blood sample. This visit should take about 30 minutes.
If your blood pressure was raised at visit 3, we will invite you to the surgery again 4 weeks later. During this visit we will take your blood pressure again. If it is still raised then we will tell the GP, who may ask to see you about it. This visit should take about 10 minutes.
Your final visit, which is about 6 months after your first trial visit date (visit 1), will be with a nurse who will take your blood pressure, take a blood sample, check your medication with you and ask you to fill in a questionnaire about your general health and lifestyle. You will need to bring all your heart/stroke medication, or your Trinomia capsules with you to this visit. This visit should take about 1 1/4 hours.
If you are taking Trinomia, we will arrange for you to see the GP who will tell you how to stop taking this and will prescribe other medicines to replace it.
The total amount of blood taken during the course of the trial will be no more than 15ml (3 teaspoons). Click on the image below to see a flow chart of the visit schedule.