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RNA-based Therapeutic
Inclisiran for Cardiovascular Disease (ORION-4 Trial)
Phase 3
Waitlist Available
Led By Marion Mafham
Research Sponsored by University of Oxford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Hypercholesterolemia
Have you at least 4 weeks of been taking statins
Must not have
Acute coronary syndrome or stroke less than 4 weeks before the Screening visit or during the Run-in period
Coronary revascularization procedure planned within the next 6 months
Timeline
Screening 15 days
Treatment 84 months
Follow Up 1 day
Awards & highlights
Pivotal Trial
Summary
This trial tests inclisiran, a new injection to lower cholesterol, in people who have had heart attacks, strokes, or surgeries for blocked arteries. It works by blocking a protein that produces bad cholesterol.
Who is the study for?
This trial is for men over 40 and women over 55 with a history of heart attack, stroke, or procedures for blocked arteries. It's not open to those planning heart surgery soon, with chronic liver disease, on dialysis/transplantation, pregnant/breastfeeding women, or anyone with severe illnesses that could interfere with the study.
What is being tested?
ORION-4 is testing whether inclisiran injections can reduce the risk of heart attacks and strokes in people who've already had cardiovascular events. Participants will be randomly assigned to receive either inclisiran or a placebo.
What are the potential side effects?
While specific side effects of inclisiran are not listed here, common ones may include injection site reactions, allergic responses, flu-like symptoms, nausea and potential interactions with other drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a heart attack or stroke in the last 4 weeks.
Select...
I am scheduled for a heart artery procedure in the next 6 months.
Select...
I have a long-term liver condition.
Select...
I have previously used inclisiran or been in a study for it.
Timeline
Screening ~ 15 days1 visit
Treatment ~ 84 months12 visits
Follow Up ~ 1 day0 visits
Screening ~ 15 days
Treatment ~ 84 months
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with a major adverse cardiovascular event (MACE)
Secondary study objectives
Number of participants with MACE among those recorded to be taking high-intensity statin at baseline
Number of participants with a composite of CHD death or myocardial infarction
Number of participants with cardiovascular death
Side effects data
From 2019 Phase 3 trial • 482 Patients • NCT0339712112%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
7%
Back pain
5%
Influenza
1%
Acute myocardial infarction
1%
Aortic valve stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Inclisiran
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InclisiranExperimental Treatment1 Intervention
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection at randomization, 3 months and then every 6 months.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered as SC injections of saline solution at randomization, 3 months and then every 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2650
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cardiovascular Disease (CVD) treatments often target lowering low-density lipoprotein cholesterol (LDL-C), a key risk factor for heart attacks and strokes. Statins work by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis, thereby reducing LDL-C levels.
Ezetimibe decreases cholesterol absorption in the intestines, providing an additional LDL-C lowering effect. PCSK9 inhibitors, such as Inclisiran, work by inhibiting the PCSK9 protein, which leads to increased recycling of LDL receptors and enhanced clearance of LDL-C from the bloodstream.
This is particularly important for CVD patients as lower LDL-C levels are associated with reduced risk of adverse cardiovascular events, such as heart attacks and strokes.
Find a Location
Who is running the clinical trial?
University of OxfordLead Sponsor
1,082 Previous Clinical Trials
16,664,305 Total Patients Enrolled
The TIMI Study GroupOTHER
12 Previous Clinical Trials
67,311 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,899 Previous Clinical Trials
4,191,280 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously used inclisiran or been in a study for it.I am scheduled for a heart artery procedure in the next 6 months.I have a long-term liver condition.I am undergoing or scheduled for kidney dialysis or a transplant.I have not had a heart attack or stroke in the last 4 weeks.I have not used, nor plan to use, PCSK9 inhibitors or drugs that can't be mixed with inclisiran recently.
Research Study Groups:
This trial has the following groups:- Group 1: Inclisiran
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 15 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 84 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
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