Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
- Conditions
- ASCVDElevated Cholesterol
- Interventions
- Drug: Placebo
- Registration Number
- NCT03399370
- Lead Sponsor
- The Medicines Company
- Brief Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1561
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Solution Placebo Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months. Inclisiran Inclisiran Sodium Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
- Primary Outcome Measures
Name Time Method Percentage Change in LDL-C From Baseline to Day 510 Baseline, Day 510 Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 Baseline, Day 90 to Day 540 Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
- Secondary Outcome Measures
Name Time Method Absolute Change in LDL-C From Baseline to Day 510 Baseline, Day 510 Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 Baseline, Day 90 to Day 540 Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 Baseline, Day 510 Percentage Change in Total Cholesterol From Baseline to Day 510 Baseline, Day 510 Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510 Baseline, Day 510 Percentage Change in Non-HDL-C From Baseline to Day 510 Baseline, Day 510
Trial Locations
- Locations (145)
Research Site 10001-069
🇺🇸Atlanta, Georgia, United States
Research Site 10001-158
🇺🇸Chicago, Illinois, United States
Research Site 10001-035
🇺🇸Chicago, Illinois, United States
Research Site 10001-014
🇺🇸Columbus, Ohio, United States
Research Site 10001-012
🇺🇸Columbus, Ohio, United States
Research Site 10001-031
🇺🇸Houston, Texas, United States
Research Site 10001-091
🇺🇸Houston, Texas, United States
Research Site 10001-061
🇺🇸Houston, Texas, United States
Research Site 10001-112
🇺🇸Las Vegas, Nevada, United States
Research Site 10001-124
🇺🇸Las Vegas, Nevada, United States
Research Site 10001-081
🇺🇸Miami, Florida, United States
Research Site 10001-140
🇺🇸Miami, Florida, United States
Research Site 10001-082
🇺🇸Indianapolis, Indiana, United States
Research Site 10001-142
🇺🇸Miami, Florida, United States
Research Site 10001-089
🇺🇸Miami, Florida, United States
Research Site 10001-120
🇺🇸Cincinnati, Ohio, United States
Research Site 10001-154
🇺🇸Cincinnati, Ohio, United States
Research Site 10001-010
🇺🇸Cincinnati, Ohio, United States
Research Site 10001-134
🇺🇸Cincinnati, Ohio, United States
Research Site 10001-071
🇺🇸San Antonio, Texas, United States
Research Site 10001-002
🇺🇸Salt Lake City, Utah, United States
Research Site 10001-052
🇺🇸Salt Lake City, Utah, United States
Research Site 10001-028
🇺🇸Hutchinson, Kansas, United States
Research Site 10001-113
🇺🇸Huntsville, Alabama, United States
Research Site 10001-132
🇺🇸Tucson, Arizona, United States
Research Site 10001-155
🇺🇸Clearwater, Florida, United States
Research Site 10001-099
🇺🇸Clearwater, Florida, United States
Research Site 10001-127
🇺🇸Daytona Beach, Florida, United States
Research Site 10001-011
🇺🇸Carlsbad, California, United States
Research Site 10001-084
🇺🇸Clearwater, Florida, United States
Research Site 10001-043
🇺🇸Northridge, California, United States
Research Site 10001-070
🇺🇸Fort Lauderdale, Florida, United States
Research Site 10001-019
🇺🇸Tucson, Arizona, United States
Research Site 10001-022
🇺🇸Northridge, California, United States
Research Site 10001-008
🇺🇸Santa Rosa, California, United States
Research Site 10001-119
🇺🇸Fleming Island, Florida, United States
Research Site 10001-048
🇺🇸Pembroke Pines, Florida, United States
Research Site 10001-123
🇺🇸Sarasota, Florida, United States
Research Site 10001-067
🇺🇸Hialeah, Florida, United States
Research Site 10001-102
🇺🇸Saint Petersburg, Florida, United States
Research Site 10001-153
🇺🇸Spring Valley, California, United States
Research Site 10001-080
🇺🇸Miami Springs, Florida, United States
Research Site 10001-039
🇺🇸Jacksonville, Florida, United States
Research Site 10001-098
🇺🇸Jacksonville, Florida, United States
Research Site 10001-027
🇺🇸Pembroke Pines, Florida, United States
Research Site 10001-003
🇺🇸Pinellas Park, Florida, United States
Research Site 10001-030
🇺🇸Miami, Florida, United States
Research Site 10001-104
🇺🇸Ponte Vedra, Florida, United States
Research Site 10001-053
🇺🇸Omaha, Nebraska, United States
Research Site 10001-021
🇺🇸Omaha, Nebraska, United States
Research Site 10001-015
🇺🇸Birmingham, Alabama, United States
Research Site 10001-037
🇺🇸Montgomery, Alabama, United States
Research Site 10001-138
🇺🇸Foley, Alabama, United States
Research Site 10001-013
🇺🇸Chandler, Arizona, United States
Research Site 10001-076
🇺🇸Saraland, Alabama, United States
Research Site 10001-058
🇺🇸Mobile, Alabama, United States
Research Site 10001-136
🇺🇸Phoenix, Arizona, United States
Research Site 10001-051
🇺🇸Surprise, Arizona, United States
Research Site 10001-004
🇺🇸Tucson, Arizona, United States
Research Site 10001-050
🇺🇸Canoga Park, California, United States
Research Site 10001-073
🇺🇸Beverly Hills, California, United States
Research Site 10001-150
🇺🇸Los Angeles, California, United States
Research Site 10001-105
🇺🇸San Ramon, California, United States
Research Site 10001-044
🇺🇸Torrance, California, United States
Research Site 10001-047
🇺🇸Boca Raton, Florida, United States
Research Site 10001-139
🇺🇸Jacksonville, Florida, United States
Research Site 10001-116
🇺🇸Miami, Florida, United States
Research Site 10001-115
🇺🇸Pembroke Pines, Florida, United States
Research Site 10001-147
🇺🇸Pembroke Pines, Florida, United States
Research Site 10001-090
🇺🇸Saint Augustine, Florida, United States
Research Site 10001-092
🇺🇸Macon, Georgia, United States
Research Site 10001-059
🇺🇸Arlington Heights, Illinois, United States
Research Site 10001-036
🇺🇸Evanston, Illinois, United States
Research Site 1001-020
🇺🇸Sellersburg, Indiana, United States
Research Site 10001-040
🇺🇸Valparaiso, Indiana, United States
Research Site 10001-074
🇺🇸West Des Moines, Iowa, United States
Research Site 10001-107
🇺🇸Owensboro, Kentucky, United States
Research Site 10001-041
🇺🇸Lake Charles, Louisiana, United States
Research Site 10001-144
🇺🇸Crowley, Louisiana, United States
Research Site 10001-101
🇺🇸Monroe, Louisiana, United States
Research Site 10001-095
🇺🇸Grandville, Michigan, United States
Research Site 10001-078
🇺🇸Sterling Heights, Michigan, United States
Research Site 10001-034
🇺🇸Troy, Michigan, United States
Research Site 10001-018
🇺🇸Edina, Minnesota, United States
Research Site 10001-156
🇺🇸Saint Louis, Missouri, United States
Research Site 10001-056
🇺🇸Saint Paul, Minnesota, United States
Research Site 10001-007
🇺🇸Saint Louis, Missouri, United States
Research Site 10001-042
🇺🇸New Windsor, New York, United States
Research Site 10001-055
🇺🇸Raritan, New Jersey, United States
Research Site 10001-129
🇺🇸Poughkeepsie, New York, United States
Research Site 10001-122
🇺🇸Binghamton, New York, United States
Research Site 10001-128
🇺🇸Endwell, New York, United States
Research Site 10001-110
🇺🇸Williamsville, New York, United States
Research Site 10001-063
🇺🇸Cary, North Carolina, United States
Research Site 10001-064
🇺🇸Greensboro, North Carolina, United States
Research Site 10001-145
🇺🇸Mooresville, North Carolina, United States
Research Site 10001-016
🇺🇸Akron, Ohio, United States
Research Site 10001-046
🇺🇸Shelby, North Carolina, United States
Research Site 10001-141
🇺🇸Dayton, Ohio, United States
Research Site 10001-148
🇺🇸Marion, Ohio, United States
Research Site 10001-017
🇺🇸Edmond, Oklahoma, United States
Research Site 10001-109
🇺🇸Wyomissing, Pennsylvania, United States
Research Site 10001-001
🇺🇸Anderson, South Carolina, United States
Research Site 10001-006
🇺🇸Greer, South Carolina, United States
Research Site 10001-075.
🇺🇸Greer, South Carolina, United States
Research Site 10001-111
🇺🇸Myrtle Beach, South Carolina, United States
Research Site 10001-026
🇺🇸Spartanburg, South Carolina, United States
Research Site 10001-133
🇺🇸Pelzer, South Carolina, United States
Research Site 10001-103
🇺🇸Rapid City, South Dakota, United States
Research Site 10001-130
🇺🇸Kingsport, Tennessee, United States
Research Site 10001-146
🇺🇸Athens, Tennessee, United States
Research Site 10001-118
🇺🇸Knoxville, Tennessee, United States
Research Site 10001-100
🇺🇸Amarillo, Texas, United States
Research Site 10001-009
🇺🇸Dallas, Texas, United States
Research Site 10001-068
🇺🇸Edinburg, Texas, United States
Research Site 10001-088
🇺🇸Houston, Texas, United States
Research Site 10001-032
🇺🇸Houston, Texas, United States
Research Site 10001-025
🇺🇸Lubbock, Texas, United States
Research Site 10001-057
🇺🇸New Braunfels, Texas, United States
Research Site 10001-106
🇺🇸Powell, Texas, United States
Research Site 10001-079
🇺🇸Round Rock, Texas, United States
Research Site 10001-045
🇺🇸Tomball, Texas, United States
Research Site 10001-149
🇺🇸Shavano Park, Texas, United States
Research Site 10001-005
🇺🇸Layton, Utah, United States
Research Site 10001-093
🇺🇸Falls Church, Virginia, United States
Research Site 10001-085
🇺🇸Manassas, Virginia, United States
Research Site 10001-094
🇺🇸Midlothian, Virginia, United States
Research Site 10001-029
🇺🇸Suffolk, Virginia, United States
Research Site 10001-077
🇺🇸Mesa, Arizona, United States
Research Site 10001-114
🇺🇸Tacoma, Washington, United States
Research Site 10001-065
🇺🇸El Cajon, California, United States
Research Site 10001-060
🇺🇸Bridgewater, New Jersey, United States
Research Site 10001-083
🇺🇸Schertz, Texas, United States
Research Site 10001-126
🇺🇸Fort Worth, Texas, United States
Research Site 10001-024
🇺🇸Flint, Michigan, United States
Research Site 10001-137
🇺🇸Dunwoody, Georgia, United States
Research Site 10001-054
🇺🇸Albany, New York, United States
Research Site 10001-033
🇺🇸Sacramento, California, United States
Research Site 10001-038
🇺🇸Tampa, Florida, United States
Research Site 10001-143
🇺🇸Tampa, Florida, United States
Research Site 10001-087
🇺🇸Austin, Texas, United States
Research Site 10001-023
🇺🇸Richmond, Virginia, United States
Research Site 10001-117
🇺🇸Austin, Texas, United States
Research Site 10001-125
🇺🇸Lexington, Kentucky, United States
Research Site 10001-108
🇺🇸Lexington, Kentucky, United States