What happens to blood samples?
About 4 teaspoons of blood will be taken each time. Numbered samples (without a name on) would be stored indefinitely at a secure location in the University of Oxford. Samples may be transferred to other collaborating scientists but would not be sent with any information identifying a participant.
The blood samples participants provide will be used to measure things which we know affect the risk of circulatory problems. This allows us to see whether the effects of inclisiran are different in different groups of people (for example people with higher or lower levels of certain risk factors). The results of blood tests will not be routinely provided to participants or GPs. However, the ORION-4 team may write to GPs about blood results if there is a particular concern.
The study nurse will also ask if participants are happy for these blood samples to be stored long-term to help investigate the effects of inclisiran and the causes of heart disease, strokes and other conditions. However, people can still take part in the study even if they do not give permission for this long-term storage.