Beating cholesterol, heart attacks and stroke - CHFT trials new drugs

CHFT is currently taking part in a pioneering trial - to test if an injection could reduce bad cholesterol and deaths from heart attacks and strokes.

The trial - on a voluntary basis - is called Orion-4 and being coordinated by Oxford University. The aim is to investigate how a drug could lower levels of bad cholesterol.

Inclisiran (currently not approved for use in the UK) will be trialled for five years - half of all volunteers taking part will be on a placebo and randomly selected.

Patients who have had a heart attack or stroke, or a procedure to unblock their artieries will be eligible.  

The trial is to find out if injections of inclisiran can lower bad cholesterol if taken every six months for several years.

Here's more about it from the team involved (pictured left to right: Dr Karen Mitchell, receptionist Melanie Burton and Research Nurses Sue Lawrence and Dianne Appleyard):

What is the aim? The aim of the study is to assess the effectiveness of the new injection of Inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.

People who have already had a heart attack, stroke or procedures to unblock arteries need to try and keep their cholesterol level low. This is usually with diet and statins, but sometimes these options are not always enough. There is a need for new drugs to be identified that may help to reduce 'bad' cholesterol more effectively, but safely.

The drug we are trialling is called Inclisiran, and it helps to reduce 'bad' cholesterol and is given by subcutaneous injection every 6 months. We hope that over several years (ie 5 years) the drug will lower the number of heart attacks and strokes, but we don't know this for certain yet.

Which patients are eligible? 

Male or female over the age of 55. Medical records which show they have had a heart attack or stroke or an operation/procedure on their arteries.

How does the trial work?

Patients are invited by letter from the University of Oxford to attend an appointment at the ORION-4 Clinic at Huddersfield Royal Infirmary. It's a voluntary participation.

About 15,000 people will take part in this study. Half will get inclisiran injections and half will get placebo (dummy) injections. Which treatment you get is decide by chance and the participant will not know which treatment is given.

Inclisiran is an investigational drug, which means it is not currently approved for use in the UK.

 

What is cholesterol etc?

Cholesterol is a fatty substance found in your blood. It's produced naturally in the liver. Everyone has cholesterol. We need it to stay healthy because every cell in our body uses it. Some of this cholesterol comes from the food we eat.

The government recommends that healthy adults should have a total cholesterol level below 5 mmol/L. In the UK , three out of five adults have a total cholesterol level of 5 mmol/L or above, and the average cholesterol level is about 5.7 mmol/L, which can be a risk factor in the development of coronary heart disease.

Too much bad cholesterol can be harmful because it sticks to the inside walls of your arteries. This can lead to fatty material (atheroma) building up - this process is known as atherosclerosis. It makes it harder for blood to flow through, which can lead to a heart attack or stroke.