Atherosclerotic Cardiovascular Disease Clinical Trial
— ORION-4Official title:
HPS-4/TIMI 65/ORION-4: A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease
Verified date | October 2023 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 16124 |
Est. completion date | December 2049 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria History or evidence of at least one of the following: - Prior MI; or - Prior ischemic stroke; or - Peripheral artery disease as evident by prior lower extremity artery revascularization or aortic aneurysm repair. Minimum age is 40 years for men and 55 years for women Exclusion Criteria None of the following must be satisfied (based on self-reported medical history): - 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; - Known chronic liver disease; - Current or planned renal dialysis or transplantation; - Previous exposure to inclisiran or participation in a randomized trial of inclisiran; - Previous (within about 3 months), current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known); - Known to be poorly compliant with clinic visits or prescribed medication; - Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; cancer or evidence of spread within approximately the last 5 years, other than non-melanoma skin cancer; or history of alcohol or substance misuse) or may put the individual at significant risk in the opinion of the investigator (or their authorised deputy) if he/she were to participate in the trial; - Women of child-bearing potential, current pregnancy, or lactation; - Current participation in a clinical trial with an unlicensed drug or device; or - Staff personnel directly involved with the study and any family member of the investigational study staff. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | CTSU, University of Oxford | Oxford | Oxfordshire |
United States | TIMI Study Group | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Novartis Pharmaceuticals, The TIMI Study Group |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with a major adverse cardiovascular event (MACE) | 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. |
Median follow-up of 5-years | |
Secondary | Number of participants with MACE among those recorded to be taking high-intensity statin at baseline | Median follow-up of 5-years | ||
Secondary | Number of participants with a composite of CHD death or myocardial infarction | Median follow-up of 5-years | ||
Secondary | Number of participants with cardiovascular death | Median follow-up of 5-years |
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