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A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease (ORION-4)

A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease

Eligibility

Inclusion Criteria

1. 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.
2. Minimum age is 40 years for men and 55 years for women

Exclusion Criteria

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. 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)
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 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 authorized 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