Inclisiran for Cardiovascular Disease
(ORION-4 Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently or have recently been treated with a monoclonal antibody targeting PCSK9, you may not be eligible to participate.
What makes the drug Inclisiran unique for treating cardiovascular disease?
Inclisiran is unique because it works by targeting and reducing the production of a specific protein involved in cholesterol regulation, which is different from other treatments that typically focus on blocking cholesterol absorption or production directly. It is administered as an injection every six months, offering a convenient dosing schedule compared to daily medications.12345
What is the purpose of this trial?
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.
Research Team
Marion Mafham
Principal Investigator
University of Oxford
David Preiss
Principal Investigator
University of Oxford
Louise Bowman
Principal Investigator
University of Oxford
Martin Landray
Principal Investigator
University of Oxford
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inclisiran or placebo via subcutaneous injection at randomization, 3 months, and then every 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Inclisiran
- Placebo
Inclisiran is already approved in European Union, United States, China for the following indications:
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
- Heterozygous familial hypercholesterolemia (HeFH)
- Clinical atherosclerotic cardiovascular disease (ASCVD)
- Primary hypercholesterolemia
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Mixed dyslipidemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oxford
Lead Sponsor
The TIMI Study Group
Collaborator
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD