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

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

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.

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);
• 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;
• 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.