This page describes the eligibility criteria for the ORION-4 study.
Participants must meet at least one of the Inclusion Criteria and none of the Exclusion Criteria.
If you have been invited to take part in ORION-4 you can use our checklist to help work out if you are eligible.
Participants must be aged at least 55 years at the time of their Screening visit, and they must have at least one of the following (based on self-reported medical history):
- Prior myocardiaI infarction (MI); or
- Prior ischemic stroke; or
- Peripheral artery disease as evident by prior lower extremity artery revascularization or aortic aneurysm repair.
Participants must have none of the following (based on self-reported medical history):
- Acute coronary syndrome or stroke less than 4 weeks before the Screening visit or during the Run-in period;
- Coronary revascularization procedure planned within the next 6 months;
- Known chronic liver disease;
- Current or planned renal dialysis or transplantation;
- Previous exposure to inclisiran or participation in a randomized trial of inclisiran;
- Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known);
- Known to be poorly compliant with clinic visits or prescribed medication;
- Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; cancer or evidence of spread within approximately the last 5 years, other than non-melanoma skin cancer; or history of alcohol or substance misuse) or may put the individual at significant risk in the opinion of the investigator (or their authorised deputy) if he/she were to participate in the trial;
- Current participation in a clinical trial with an unlicensed drug or device; or
- Staff personnel directly involved with the study and any family member of the investigational study staff.
In addition, at the Randomization visit, individuals will be excluded if they are no longer willing to continue or their doctor does not wish them to be randomized.
Patients who are ineligible based on a temporary exclusion criterion (e.g. recent acute MI) may be invited to attend a re-screening appointment after a suitable delay.