Locations
Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), Lake City, Macon, St. AugustineCondition
Cholesterol, Heart DiseaseA 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
clinicaltrials.govEligibility
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
- 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 authorized 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
- Staff personnel directly involved with the study and any family member of the investigational study staff