Active not recruitingPHASE3INTERVENTIONAL

A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

ORION-4 is a research study looking at a new injectable medicine called inclisiran. If you've had a heart attack, stroke, or treatment for blocked arteries, this study wants to see if inclisiran can safely reduce your chances of having these problems again. It's trying to find out if this medicine, which helps lower "bad" cholesterol, can protect your heart and blood vessels. The study is run by the University of Oxford and will involve many people in the UK and USA. Participants will either receive the inclisiran injection or a dummy injection (placebo) over several years to compare how well it works and if it's safe.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Oxford

Enrolment target

16,124

Start

30 Oct 2018

Estimated completion

01 Dec 2049

Atherosclerotic Cardiovascular Disease

What is this study about?

This study, called ORION-4, is investigating a new medicine named inclisiran. We know that high levels of a type of cholesterol, often called "bad cholesterol" (LDL-cholesterol), can lead to serious health problems like heart attacks and strokes. Many people who have already experienced a heart attack, stroke, or had a procedure to unblock arteries are at a higher risk of these events happening again.

The main goal of ORION-4 is to see if inclisiran can safely lower this risk. It's an injection that helps reduce bad cholesterol. Researchers want to compare people who receive inclisiran with those who receive a dummy injection (placebo) to truly understand its effects. This will help doctors know if inclisiran is a good option for protecting people's hearts and blood vessels in the long term.

The study is in its third phase (Phase 3), which means it's one of the final steps before a new medicine might be approved for wider use. It's a large study, involving about 15,000 people across the UK and USA, and it's being managed by experts at the University of Oxford. The information gathered will be crucial for understanding how well inclisiran works and if it's safe for people who already have heart and blood vessel disease.

Key takeaways

Tests a new injection (inclisiran) for heart and stroke risk.
For people who have already had a heart attack, stroke, or artery treatment.
Compares inclisiran to a dummy injection (placebo).
Injections given twice in the first three months, then every six months.
The study plans to last about five years.
Aims to see if inclisiran can safely protect against future heart problems.

Who may be eligible?

You might be able to join this study if you've already had certain heart and blood vessel problems. This includes having had a heart attack, a certain type of stroke, or an operation or procedure to treat blocked arteries in your legs or elsewhere.

Men need to be at least 40 years old, and women need to be at least 55 years old to be considered for this study. All participants must have pre-existing heart or blood vessel disease where arteries become narrowed or blocked.

There are also some reasons why you wouldn't be able to join. For example, if you've had a recent heart attack or stroke in the last month, or if you're planning to have heart surgery soon. People with certain severe long-term illnesses like serious liver disease, or those receiving kidney dialysis, wouldn't be able to take part. Also, if you're pregnant, breastfeeding, or could become pregnant, this study isn't suitable. If you've previously taken part in an inclisiran study or a similar type of drug study, you won't be able to join this one.

Quick self-check

Have you previously had a heart attack or a stroke?
Have you had surgery or a procedure to unblock arteries?
Are you a man at least 40 years old, or a woman at least 55 years old?
Are you NOT pregnant or breastfeeding, and not planning to become pregnant?
Have you NOT had a heart attack or stroke in the last month?
Are you NOT currently in another study using an experimental medicine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the ORION-4 study, you'll be assigned by chance to receive either the inclisiran injection or a dummy injection (placebo). There's a 50/50 chance of getting either one. You won't know which one you're receiving, and neither will your study doctor.

The injections are given under the skin. You'll receive your first injection when you start the study, then another three months later, and then every six months after that. This means you'll have study visits to receive your injections and for health checks. The study is planned to last for about five years, during which time your health will be carefully monitored.

Potential risks and benefits

Taking part in any clinical study has potential benefits and potential risks. You might benefit from closer medical monitoring and possibly from the new treatment itself, if it proves effective. However, there's also a chance you could receive the dummy injection, and the new medicine might have side effects that aren't fully known yet. You can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

TIMI Study Group
Boston, United States
CTSU, University of Oxford
Oxford, United Kingdom

Common questions

What is inclisiran?

Inclisiran is a new injectable medicine being studied to see if it can lower 'bad' cholesterol and reduce the risk of heart attacks and strokes.

What does 'randomized' mean?

It means you'll be assigned by chance, like flipping a coin, to either receive the inclisiran medicine or a dummy injection (placebo).

How often will I need injections?

After your first two injections three months apart, you'll receive an injection every six months for the rest of the study.

How long will the study last?

The study is planned to last for about five years.

What is 'atherosclerotic cardiovascular disease'?

This is a condition where your arteries become narrowed and hardened due to a build-up of fatty substances (cholesterol), which can lead to heart attacks and strokes.