Novartis study CKJX839D12302

Overview / Background

This study started enrolling in Autumn 2023 and has now enrolled 14,000 participants in over 45 countries  
 
At Wansford research, we screened 34 patients and 31 patients were enrolled ( randomised to either the study treatment Inclisiran or placebo on a 50:50 % chance split)
Our site target was 20 patients so  we were please to recruit 50% above target mainly from our own patients but we also extended the study into a deprived and more diverse population at Boroughbury medical practice in Central Peterborough .
 
The aim of the study is to find out if the study treatment, called inclisiran, can help prevent cardiovascular events (such as heart attacks , strokes and death) in adults who are at cardiovascular risk but have not had a major cardiovascular event and have high cholesterol despite existing therapies such as statins.  This is often referred to as “primary prevention”.

Having raised LDL-cholesterol (also known as “bad” cholesterol) in your blood can lead to LDL-cholesterol build up inside your artery walls, creating a thick and fatty deposit (or plaque) that can reduce blood flow. Blocked arteries can lead to important cardiovascular events, such as heart attack, stroke, or cardiovascular-related death.

Inclisiran has been studied in people with existing  cardiovascular disease in multiple clinical trials to assess inclisiran’ s ability to reduce LDL-cholesterol and is  now available to prescribe in the UK to patients who have heart disease and existing treatments have not lowered cholesterol to target levels. https://www.heartuk.org.uk/getting-treatment/inclisiran
 
This study will help understand if a reduction in LDL-cholesterol with inclisiran in primary prevention patients will also help prevent heart attacks and strokes from occurring and so help the NHS to assess if the drug could be used more widely in the future . The most common risk/side effect of study medication administration is injection site reactions (local skin reactions at the injection site), occurring in less than 10% of patient. No serious reactions have been seen so far.