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RNA-based Therapeutic

Inclisiran for Cardiovascular Disease (ORION-4 Trial)

Phase 3

Waitlist Available

Led By Louise Bowman

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

ORION-4 Trial Summary

This trial is testing a new cholesterol-lowering injection to see if it safely lowers the risk of heart attacks and strokes.

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.Check my eligibility

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.See study design

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.

ORION-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion 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.

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I have a long-term liver condition.

Select...

I have previously used inclisiran or been in a study for it.

ORION-4 Trial Timeline

Screening ~ 15 days1 visit

Treatment ~ 84 months12 visits

Follow Up ~ 1 day0 visits

Screening ~ 15 days

Treatment ~ 84 months

Follow Up ~1 day

This trial's timeline: 15 days for screening, 84 months for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with a major adverse cardiovascular event (MACE)

Secondary outcome measures

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 • NCT03397121

12%

Nasopharyngitis

Injection site reaction

Upper respiratory tract infection

Back pain

Influenza

Acute myocardial infarction

Aortic valve stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Inclisiran

ORION-4 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

~2240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OxfordLead Sponsor

1,056 Previous Clinical Trials

16,186,254 Total Patients Enrolled

The TIMI Study GroupOTHER

12 Previous Clinical Trials

67,311 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,863 Previous Clinical Trials

4,183,211 Total Patients Enrolled

Media Library

Inclisiran (RNA-based Therapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT03705234 — Phase 3

Cardiovascular Disease Research Study Groups: Inclisiran, Placebo

Cardiovascular Disease Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT03705234 — Phase 3

Inclisiran (RNA-based Therapeutic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705234 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When will Inclisiran be available for general public use?

"Inclisiran has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, indicating that there is evidence of the drug's efficacy as well as data from multiple rounds of safety testing."

Answered by AI

What medical condition is Inclisiran most frequently used to treat?

"Inclisiran is most commonly used as a treatment for primary hypercholesterolemia, but can also help manage other cholesterol-related conditions like diet and atherosclerotic cardiovascular diseases."

Answered by AI

Is this the first time Inclisiran has been used in research?

"Right now, there are 11 ongoing clinical trials evaluating the effects of Inclisiran. 10 of these trials are currently in Phase 3. Additionally, these trials are being conducted in 1407 different locations, with a notable concentration in Bayamon, Gauteng."

Answered by AI

Are new participants being accepted into this research project at this time?

"Yes, this clinical trial is recruiting patients as of today. The listing was first posted on October 30th, 2018 and was last updated on September 14th, 2020."

Answered by AI

How many people are subjects in this experiment?

"That is correct. The listing on clinicaltrials.gov says that this trial is looking for patients as we speak. The trial was first posted on October 30th, 2018 and was last edited on September 14th, 2020. They are looking for 15,000 patients at 1 location."

Answered by AI

As far as you know, does this research project have any predecessors?

"Inclisiran has been the focus of medical research since 2018 when the first trial was sponsored by Novartis Pharmaceuticals. That initial study involved 15000 participants. After the success of the 2018 trial, Inclisiran received Phase 3 drug approval. As of today, there are 11 active studies involving Inclisiran being conducted in 587 cities and 51 countries."

Answered by AI