HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
University of Oxford
Duration of Study in the UK
6 years, 3 months, 31 days
Previous trials have shown that lowering bad (LDL) cholesterol with statins reduces the risk of heart attacks and strokes. However, among individuals with a previous history of vascular disease, the risk of a further vascular event remains high, even after several years of statin treatment.
Inclisiran is an investigational drug given by subcutaneous (under the skin) injection which lowers bad (LDL) cholesterol. This study aims to find out whether inclisiran, given every 6 months for about 5 years, safely reduces the risk of heart attacks, strokes or the need for urgent coronary angioplasty or bypass grafts, in people who already have known vascular disease.
People are eligible to join the study if they are aged 55 years or older and have known vascular disease (that is they have had a heart attack, stroke or leg artery bypass or angioplasty, or aortic aneurysm repair).
The study will involve 15,000 participants (12,000 in the UK and 3000 in the US). Half of the participants will receive inclisiran injections and half will receive inactive dummy injections (placebo). Which treatment each participant receives will be decided by randomization (like tossing coin). Neither the participants, nor the study staff will know which treatment they are receiving (but this can be found out if needed). Participants will continue their usual medication prescribed by their GP or other doctors.
ORION-4 study clinics will be set up by NHS and academic institutions and will be run by trained research staff. Participants will attend the study clinic four times in the first nine months and then once every six months. At each clinic visit they will be asked questions about their health, will have a blood sample taken and will be given an injection of inclisiran or placebo.
South Central - Oxford C Research Ethics Committee
Date of REC Opinion
31 May 2018