A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease (ORION-4)
- Conditions
- Myocardial infarction and stroke in people with atherosclerosisCirculatory System
- Registration Number
- ISRCTN88876914
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 16124
History or evidence of at least one of the following:
1. Prior MI
2. Prior ischemic stroke
3. Peripheral artery disease as evident by prior lower extremity artery revascularization or aortic aneurysm repair
4. Minimum age of 40 years for men and 55 years for women. (added 21/09/2022)
None of the following must be satisfied (based on self-reported medical history):
1. Acute coronary syndrome or stroke less than 4 weeks before the Screening visit or during the Run-in period
2. Coronary revascularization procedure planned within the next 6 months
3. Known chronic liver disease
4. Current or planned renal dialysis or transplantation
5. Previous exposure to inclisiran or participation in a randomized trial of inclisiran
6. Current participant exclusion criterion as of 15/01/2020: 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).
Previous participant exclusion criterion: Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known)
7. Known to be poorly compliant with clinic visits or prescribed medication
8. 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 nonmelanoma 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
9. Women of child-bearing potential, current pregnancy, or lactation
10. Current participation in a clinical trial with an unlicensed drug or device
11. Staff personnel directly involved with the study and any family member of the investigational study staff
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method