I have seen an advert for the StatinWISE trial and I'd like to find out more. What should I do next?
Welcome to the StatinWISE website! StatinWISE is a trial designed to find out whether statins cause muscle symptoms. If you have experienced muscle symptoms while using statins and want to find out whether statins were the cause of your symptoms, then StatinWISE could be for you!
Watch our videos and have a look through the website to find out more about the trial. If you think you might be interested in taking part, then click on 'Patient expression of interest form" and somebody from the trial team will get in touch with you.
I have been invited to take part in the StatinWISE trial. What should I do next?
We're really pleased that you're considering taking part. Your GP practice or patient identification centre (PIC) should have given you an information leaflet about the StatinWISE study. You can see an example leaflet by clicking this link. If you would like to take part or find out more, then contact your GP practice directly using the number on the back of your Patient Information Sheet. Alternatively email firstname.lastname@example.org
If you're unsure then contact us and we'll put you in touch with the right person.
What is required of me?
You will be invited to go to your GP surgery or to a referral centre for a baseline visit, where a research nurse will explain the trial to you and make sure you are suitable.
Your study medication will be sent directly to you in the post. The treatment packs have been designed to fit through a standard letterbox. You will be asked to take one capsule every day for one year. Every two months, you will be asked to tell us about your muscle symptoms for seven days and to fill in one questionnaire. You can do this using our mobile phone app, website, over the telephone, or using pen and paper.
At the end of the 12-months treatment, you will have a phone call or face to face appointment with a research nurse or your GP, to discuss your study results. Following this, the Clinical Trials Unit will call you one month later to discuss whether or not you decided to continue using statins.
What's in it for me?
If you take part in StatinWISE, you will be closely monitored for the duration of the trial and will be in regular contact with the Clinical Trials Unit.
Within one month of you completing the study medication, you will be contacted to go through your study results. The results of the trial will be personalised to you. These results will comprise of a series of graphs to help you understand how your pain changed in relation to talking statin or placebo.
This way, you will find out whether your muscle symptoms were worse when you were taking statins compared to when you were taking placebo. This will help you to decide whether to continue taking statins or not.
I am a patient with symptoms that I think are caused by statins. How can I join the trial?
You can take part in the StatinWISE trial if your general practice is one of our collaborators and you meet our eligibility criteria:
- You must have been previously prescribed statins;
- You must either have stopped taking your statins within the last 3 years or you are considering stopping them due to muscle-related side-effects;
- Your GP must believe that you are eligible for the trial;
- You must be over the age of 16.
If you are not registered at one of our collaborators, you can still take part by attending one of our two referral centres that are in London. These two sites are the William Harvey Heart Centre, Barts & The London School of Medicine & Dentistry, EC1M 6BQ and The Hurley Clinic, Kennington Lane, Lambeth SE11 4HJ. All reasonable out of pocket travel expenses will be paid.
If your general practice is not in our list of collaborators and you are unable to attend one of our London recruitment centres, then you can't currently take part in StatinWISE. For more information, please contact us.
I have questions about my treatment. What should I do?
If you have any questions or concerns about your treatment, please contact your doctor in the first instance.
My next treatment pack hasn't arrived. What should I do?
If your next treatment pack hasn't arrived, then contact the CTU.
I'm having trouble submitting my symptom data.
Contact the CTU to let us know.
I forgot to take my study medication. What should I do?
Continue taking your doses as scheduled. At the end of the two-month treatment period, you will receive a questionnaire asking about your use of study medication. Make sure you fill this in to let us know that you have missed any days' pills. And don't forget to return any unused medication to us in the envelope provided with your treatment pack.