Orion-4 trials taking place at NCIC
North Cumbria Integrated Care NHS Foundation Trust is taking part in a new medical research study to help find out if a new treatment can help prevent heart attacks and strokes.
The ORION-4 project is a double-blind randomized placebo-controlled trial, assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.
It is testing whether a medicine called inclisiran, which is given by subcutaneous injection approximately every six months, can safely help to prevent heart attacks and strokes in patients who are known to have diseased arteries.
The trial is coordinated by Oxford Clinical Trial Services Unit (CTSU), University of Oxford and aims to recruit about 15,000 participants from the UK and the USA.
In the UK, there will be about 90 to 100 sites recruiting 12,000 patients during the study period and the West Cumberland Hospital and the Cumberland Infirmary are two of those sites.
At West Cumberland Hospital, the ORION-4 research clinic has been run in the Cardiology Outpatient Department since October 2019 and it started at the Cumberland Infirmary in April 2019.
It is a nurse led clinic – coordinated by Rosemary Harper, Clinical Research Nurse with clinical oversight – from the Local Lead Investigator Professor Gershan Davis.
The ORION-4 project is run at both West Cumberland Hospital and the Cumberland Infirmary – both are classed as separate recruiting sites.
Una Poultney, Research Team Leader at West Cumberland Hospital, said: “The Oxford Clinical Trial Services Unit (CTSU) send invitation letters on behalf of the local investigator to attend a screening appointment at the ORION-4 clinic at the West Cumberland Hospital.
“If it is appropriate for patients to be involved in the study, they attend a further randomisation appointment and are then followed up for about five years.”
Professor Davis, who works as a consultant cardiologist at NCIC and is UCLan Professor of Cardiovascular Medicine, said: “It has been shown that patients and departments involved in research have better outcomes and standards of care.
“The new department and dedicated Coronary Care Unit at West Cumberland Hospital gives us the opportunity to develop in this regard.
“We have recently launched studies in heart failure and reducing cholesterol with great patient interest.”
Also involved is Dr Jacek Majewski, a consultant cardiologist, honorary senior lecturer at UCLan School of Medicine and Local Lead Investigator at CIC.
He said: “Participation in the ORION trial is a great opportunity for both hospitals to further develop cooperation and improve outcomes of cardiovascular prevention in Cumbria.”