Join the study
Are you eligible to take part in the new study?
- You must have completed a final (close-out) visit for FOURIER (whether you were still taking study medication or not).
- You must have not been recruited into the FOURIER open-label extension study.
- You are still eligible for the FOURIER Legacy study if you have joined other clinical trials, as the LEGACY study does not involve taking any medication and is only a questionnaire follow up.
How to get involved with the FOURIER Legacy study
Participants will be initially contacted by their original FOURIER centre and asked whether they would be interested in taking part in the LEGACY study and, if so, whether they would consent to their details being forwarded to the National Coordinating Centre (Imperial College London for UK participants).
Participants will also be sent a copy of the patient information sheet and Privacy notice for FOURIER Legacy (DOC).
Informed consent to participate
Investigators from the National Coordinating Centre at Imperial College London will contact each person by telephone and explain the information that is contained in the Participant info and consent form FOURIER (doc), and answer any study-related questions. If you wish to participate in the study, you will be asked to complete, sign and date the consent form on the last page of the patient information sheet, initial every page and post the completed form to Imperial. The consent form will then be counter-signed by a study investigator and a copy returned to the subject.
Having given informed consent, subjects will be invited to enrol to the study online using a unique ID and pin number, and will be asked to complete their online questionnaire. If participants prefer, this process can be done by study staff during a telephone call.
The questions will include:
Since you last made contact with us have you suffered from any of the following new health events?
(i) a new heart attack?
(ii) a new stroke?
(iii) had one or more new coronary angioplasties or coronary stenting?
(iv) had new coronary artery bypass surgery?
(v) had a new angioplasty or stenting to the leg vessels?
(vii) been admitted to hospital for your heart condition? (cardiovascular hospitalization is defined as hospitalization for any cardiovascular (heart or blood vessel) reason)
(viii) Are you still taking a statin tablet to lower your cholesterol (you needed to be taking one to take part in the FOURIER trial)?
(ix) Are you still taking a cholesterol lowering injection (PCSK9 inhibitor drug) similar to as in the FOURIER trial (you needed to start one when you joined the FOURIER trial)?
(x) Are you taking a medication (such as ezetimibe) to slow absorption of cholesterol from your diet?
Participants will be sent a reminder by text or email when they are due to complete a follow up questionnaire. They can then access the database and complete their questionnaire or request that this can be done by a telephone call with a member of the study team.
The questionnaire will be completed at enrolment, 6 and 12 months after enrolmen,t and annually up to 5 years following the closure of the FOURIER outcomes trial (i.e. around December 2021).