Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)
ASCVD, Elevated Cholesterol
About this trial
This is an interventional treatment trial for ASCVD focused on measuring Inclisiran sodium, ASCVD, LDL-C
Eligibility Criteria
Inclusion Criteria:
- Male or female participants ≥18 years of age.
- History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
- Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
- Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
- Participants on statins should be receiving a maximally tolerated dose.
- Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
- Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.
Exclusion Criteria:
- New York Heart Association (NYHA) class IV heart failure.
- Uncontrolled cardiac arrhythmia
- Uncontrolled severe hypertension
- Active liver disease
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
- Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
- Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
- Women who are surgically sterilized at least 3 months prior to enrollment.
- Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
- Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Research Site 10001-015
- Research Site 10001-138
- Research Site 10001-113
- Research Site 10001-058
- Research Site 10001-037
- Research Site 10001-076
- Research Site 10001-013
- Research Site 10001-077
- Research Site 10001-136
- Research Site 10001-051
- Research Site 10001-019
- Research Site 10001-004
- Research Site 10001-132
- Research Site 10001-073
- Research Site 10001-050
- Research Site 10001-011
- Research Site 10001-065
- Research Site 10001-150
- Research Site 10001-043
- Research Site 10001-022
- Research Site 10001-033
- Research Site 10001-105
- Research Site 10001-008
- Research Site 10001-153
- Research Site 10001-044
- Research Site 10001-047
- Research Site 10001-084
- Research Site 10001-155
- Research Site 10001-099
- Research Site 10001-127
- Research Site 10001-119
- Research Site 10001-070
- Research Site 10001-067
- Research Site 10001-139
- Research Site 10001-039
- Research Site 10001-098
- Research Site 10001-080
- Research Site 10001-081
- Research Site 10001-140
- Research Site 10001-142
- Research Site 10001-030
- Research Site 10001-089
- Research Site 10001-116
- Research Site 10001-027
- Research Site 10001-115
- Research Site 10001-048
- Research Site 10001-147
- Research Site 10001-003
- Research Site 10001-104
- Research Site 10001-090
- Research Site 10001-102
- Research Site 10001-123
- Research Site 10001-038
- Research Site 10001-143
- Research Site 10001-069
- Research Site 10001-137
- Research Site 10001-092
- Research Site 10001-059
- Research Site 10001-158
- Research Site 10001-035
- Research Site 10001-036
- Research Site 10001-082
- Research Site 1001-020
- Research Site 10001-040
- Research Site 10001-074
- Research Site 10001-028
- Research Site 10001-125
- Research Site 10001-108
- Research Site 10001-107
- Research Site 10001-144
- Research Site 10001-041
- Research Site 10001-101
- Research Site 10001-024
- Research Site 10001-095
- Research Site 10001-078
- Research Site 10001-034
- Research Site 10001-018
- Research Site 10001-056
- Research Site 10001-156
- Research Site 10001-007
- Research Site 10001-053
- Research Site 10001-021
- Research Site 10001-112
- Research Site 10001-124
- Research Site 10001-060
- Research Site 10001-055
- Research Site 10001-054
- Research Site 10001-122
- Research Site 10001-128
- Research Site 10001-042
- Research Site 10001-129
- Research Site 10001-110
- Research Site 10001-063
- Research Site 10001-064
- Research Site 10001-145
- Research Site 10001-046
- Research Site 10001-016
- Research Site 10001-120
- Research Site 10001-154
- Research Site 10001-010
- Research Site 10001-134
- Research Site 10001-014
- Research Site 10001-012
- Research Site 10001-141
- Research Site 10001-148
- Research Site 10001-017
- Research Site 10001-109
- Research Site 10001-001
- Research Site 10001-006
- Research Site 10001-075.
- Research Site 10001-111
- Research Site 10001-133
- Research Site 10001-026
- Research Site 10001-103
- Research Site 10001-146
- Research Site 10001-130
- Research Site 10001-118
- Research Site 10001-100
- Research Site 10001-087
- Research Site 10001-117
- Research Site 10001-009
- Research Site 10001-068
- Research Site 10001-126
- Research Site 10001-031
- Research Site 10001-088
- Research Site 10001-091
- Research Site 10001-061
- Research Site 10001-032
- Research Site 10001-025
- Research Site 10001-057
- Research Site 10001-106
- Research Site 10001-079
- Research Site 10001-071
- Research Site 10001-083
- Research Site 10001-149
- Research Site 10001-045
- Research Site 10001-005
- Research Site 10001-002
- Research Site 10001-052
- Research Site 10001-093
- Research Site 10001-085
- Research Site 10001-094
- Research Site 10001-023
- Research Site 10001-029
- Research Site 10001-114
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Inclisiran
Saline Solution
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.