A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
- Conditions
- Atherosclerotic Cardiovascular Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT03705234
- Lead Sponsor
- University of Oxford
- Brief Summary
ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
- Detailed Description
The ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Inclisiran is a PCKS9 synthesis inhibitor which has been found to reduce LDL-cholesterol by about 50-60%. ORION-4 will investigate the effects of inclisiran on major adverse cardiovascular events.
The study is intended to be conducted at approximately 180 clinical sites in the UK and the USA. Approximately 15,000 participants aged 40 years or older for men, and 55 years or older for women, with pre-existing atherosclerotic cardiovascular disease will be randomized between inclisiran sodium 300 mg and matching placebo (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) in a 1:1 ratio for a planned median duration of about 5 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 16124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administered as SC injections of saline solution at randomization, 3 months and then every 6 months. Inclisiran Inclisiran Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection at randomization, 3 months and then every 6 months.
- Primary Outcome Measures
Name Time Method Number of participants with a major adverse cardiovascular event (MACE) Median follow-up of 5-years Defined as time to first occurrence - during the scheduled treatment period - of:
* Coronary heart disease (CHD) death;
* Myocardial infarction;
* Fatal or non-fatal ischemic stroke; or
* Urgent coronary revascularization procedure.
- Secondary Outcome Measures
Name Time Method Number of participants with MACE among those recorded to be taking high-intensity statin at baseline Median follow-up of 5-years Number of participants with a composite of CHD death or myocardial infarction Median follow-up of 5-years Number of participants with cardiovascular death Median follow-up of 5-years
Trial Locations
- Locations (2)
CTSU, University of Oxford
馃嚞馃嚙Oxford, Oxfordshire, United Kingdom
TIMI Study Group
馃嚭馃嚫Boston, Massachusetts, United States