Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry.
Ann Marie Navar, Nishant P Shah, Peter Shrader...
https://pubmed.ncbi.nlm.nih.gov/38972336Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06909565
Evaluation of Inclisiran Versus Placebo for Preventing Major Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary or Peripheral Endovascular Intervention
Led by Duke University · Updated on 2026-06-04
6000
Participants Needed
99
Research Sites
8 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of inclisiran, a twice-yearly subcutaneous injection, in preventing major cardiovascular and limb events in patients undergoing percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI). This pragmatic, randomized, double-blind, placebo-controlled study will enroll about 6,000 patients with symptomatic atherosclerotic cardiovascular disease, either coronary artery disease or peripheral artery disease, to understand how inclisiran may be used in real-world clinical practice. Participants will be randomly assigned to receive either inclisiran sodium 300 mg injections or a matching placebo. The injections will be given on Day 1, Month 3 (Day 90), and every six months thereafter. The first dose will be administered at or within 14 days after a successful revascularization procedure. All participants will continue to receive usual medical care throughout the study. The treatment period for each participant is expected to last up to approximately 45 months, with an average of 36 months of follow-up. During the study, participants will be monitored for major adverse cardiovascular events (MACE) and major adverse limb events (MALE), starting from randomization up to about four years. Researchers will also track cardiovascular deaths, all-cause deaths, and venous thromboembolic events. The study is event-driven, continuing until enough events have occurred to meet study goals. Participants will attend regular visits for injections and assessments, ensuring ongoing safety monitoring and evaluation of treatment effects.
CONDITIONS
Brief Title
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Male or female aged 18 years or older
- Within 14 days of a successful percutaneous coronary or peripheral endovascular intervention for symptomatic coronary artery or peripheral artery disease
- If undergoing planned staged interventions, eligible only after the last planned procedure
You will not qualify if you...
- Planned future percutaneous coronary or peripheral endovascular intervention
- Current or planned use of an open-label PCSK9 inhibitor during the study
- Previous treatment with inclisiran
- Active or planned participation in another clinical study with investigational drugs or devices
- Serious liver disease, metabolic disease, cancer, end-stage kidney disease, or other conditions that may interfere with participation
- Any reason judged by the investigator that makes the participant unsuitable for the study, including safety or ability to follow the protocol
- Use of prohibited therapies listed in the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 14 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - Up to approximately 45 months
Participants receive subcutaneous injections of inclisiran or placebo starting at randomization, followed by doses at Month 3 and every 6 months thereafter, alongside usual care.
Dosing visits at Day 0, Month 3, and every 6 months thereafter until study end
Follow-up
Duration - Up to approximately 4 years
Participants are monitored for cardiovascular and limb events as well as safety until the end of the study.
Regular follow-up visits as per study schedule until study completion
Trial Site Locations
Total: 99 locations
1
Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
Actively Recruiting
2
Cardiology, PC
Birmingham, Alabama, United States, 35211
Actively Recruiting
3
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
Actively Recruiting
4
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Actively Recruiting
6
Valley Clinical Trials
Covina, California, United States, 91723
Withdrawn
7
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, United States, 92663
Actively Recruiting
8
Valley Clinical Trials, LLC - Flourish Research
Northridge, California, United States, 91325
Actively Recruiting
9
Riverside Community Hospital
Riverside, California, United States, 92501
Actively Recruiting
10
San Diego Cardiac Center
San Diego, California, United States, 92123
Actively Recruiting
11
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
12
The Heart Medical Group
Van Nuys, California, United States, 91406
Actively Recruiting
13
FOMAT - West Coast Research Center
Ventura, California, United States, 93030
Actively Recruiting
14
Interventional Cardiology Medical Group
West Hills, California, United States, 91307
Actively Recruiting
15
Nuvance Health- Danbury Hospital
Danbury, Connecticut, United States, 06810
Actively Recruiting
16
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States, 06305
Actively Recruiting
17
BayCare Medical Group
Clearwater, Florida, United States, 33756
Actively Recruiting
18
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
Actively Recruiting
19
Pioneer Clinical Studies
Coral Gables, Florida, United States, 33134
Actively Recruiting
20
Arrow Clinical Trails
Daytona Beach, Florida, United States, 32117
Actively Recruiting
21
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
Largo, Florida, United States, 33777
Actively Recruiting
22
Inpatient Research Clinic, LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
23
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States, 32405
Actively Recruiting
24
Charlotte Heart & Vascular Center, PA
Port Charlotte, Florida, United States, 33948
Actively Recruiting
25
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, United States, 34695
Actively Recruiting
26
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States, 33614
Actively Recruiting
27
Northeast Georgia Heart Center, PC
Gainesville, Georgia, United States, 30501
Actively Recruiting
28
Javara, Inc.
Peachtree City, Georgia, United States, 30269
Actively Recruiting
29
Atlanta Heart Specialists LLC
Tucker, Georgia, United States, 30084
Actively Recruiting
30
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States, 46514
Actively Recruiting
31
Reid Physician Associates
Richmond, Indiana, United States, 47374
Actively Recruiting
32
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
33
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States, 66211
Actively Recruiting
34
Research Integrity, LLC
Owensboro, Kentucky, United States, 42303
Actively Recruiting
35
Grace Research, LLC
Bossier City, Louisiana, United States, 71111
Actively Recruiting
36
Louisiana Heart Center
Covington, Louisiana, United States, 70433
Actively Recruiting
37
Tulane School of Medicine
New Orleans, Louisiana, United States, 70112
Actively Recruiting
38
Cardiovascular Solutions, LLC
Shreveport, Louisiana, United States, 71103
Actively Recruiting
39
Monroe Research LLC
West Monroe, Louisiana, United States, 71291
Actively Recruiting
40
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
41
Capitol Cardiology Associates PA
Lanham, Maryland, United States, 20706
Actively Recruiting
42
Shady Grove Adventist Hospital
Rockville, Maryland, United States, 20850
Actively Recruiting
43
TidalHealth Peninsula Regional
Salisbury, Maryland, United States, 21804
Actively Recruiting
44
Jadestone Clinical Research, LLC
Silver Spring, Maryland, United States, 20904
Actively Recruiting
45
UMH-Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
Actively Recruiting
46
MyMichigan Medical Center Midland
Midland, Michigan, United States, 48670
Actively Recruiting
47
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
Rochester Hills, Michigan, United States, 48307
Actively Recruiting
48
Aspirus Saint Luke's Hospital
Duluth, Minnesota, United States, 55805
Actively Recruiting
49
JAVARA Inc, - Mankato Clinic
Mankato, Minnesota, United States, 56001
Actively Recruiting
50
Stern Cardiovascular
Southaven, Mississippi, United States, 38671
Actively Recruiting
51
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States, 38801
Actively Recruiting
52
CHI Health Nebraska Heart
Grand Island, Nebraska, United States, 68803
Actively Recruiting
53
Bryan Heart
Lincoln, Nebraska, United States, 68506
Actively Recruiting
54
CHI Health Nebraska Heart
Lincoln, Nebraska, United States, 68526
Actively Recruiting
55
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, United States, 68114
Actively Recruiting
56
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
57
Advanced Heart Care LLC
Bridgewater, New Jersey, United States, 08807
Actively Recruiting
58
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States, 08318
Actively Recruiting
59
Advanced Heart and Vascular Institute Of Hunterdon
Flemington, New Jersey, United States, 08822
Actively Recruiting
60
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States, 08035
Actively Recruiting
61
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
Actively Recruiting
62
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States, 08080
Actively Recruiting
63
Capital Cardiology Associates
Albany, New York, United States, 12211
Actively Recruiting
64
Sisters of Charity Hospital
Buffalo, New York, United States, 14214
Actively Recruiting
65
Trinity Medical WNY, PC
Buffalo, New York, United States, 14214
Actively Recruiting
66
Mount Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
67
Hudson Valley Cardiovascular Practice PC
Poughkeepsie, New York, United States, 12601
Actively Recruiting
68
Richmond University Medical Center
Staten Island, New York, United States, 10310
Actively Recruiting
69
Asheville Cardiology Associates Research Department
Asheville, North Carolina, United States, 28803
Actively Recruiting
70
Novant Health Clinical Research/Heart & Vascular Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
71
Mecklenburg Heart Specialists
Charlotte, North Carolina, United States, 28207
Actively Recruiting
72
Javara Inc.
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
73
Duke Cardiology
Morrisville, North Carolina, United States, 27560
Actively Recruiting
74
Aultman Hospital
Canton, Ohio, United States, 44710
Actively Recruiting
75
Heart House Research Foundation LLC
Springfield, Ohio, United States, 45505
Actively Recruiting
76
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
Actively Recruiting
77
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States, 73135
Actively Recruiting
78
Capital Area Research LLC
Camp Hill, Pennsylvania, United States, 17011
Actively Recruiting
79
Wellspan Chambersburg Hospital
Chambersburg, Pennsylvania, United States, 17201
Actively Recruiting
80
Cardiology Associates of West Reading
West Reading, Pennsylvania, United States, 19611
Actively Recruiting
81
WellSpan Heart and Vascular Research
York, Pennsylvania, United States, 17403
Actively Recruiting
82
AnMed Health Medical Center
Anderson, South Carolina, United States, 29621
Actively Recruiting
83
Stern Cardiovascular Center
Germantown, Tennessee, United States, 38138
Actively Recruiting
84
Apex Research Foundation, LLC
Jackson, Tennessee, United States, 38301
Actively Recruiting
85
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
86
PharmaTex Research
Amarillo, Texas, United States, 79106
Actively Recruiting
87
Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, United States, 79124
Actively Recruiting
88
Austin Heart
Austin, Texas, United States, 78705
Actively Recruiting
89
Javara inc.
Conroe, Texas, United States, 77384
Actively Recruiting
90
Texas Cardiology Associates of Houston
Kingwood, Texas, United States, 77339
Actively Recruiting
91
Heart Institute of East Texas
Lufkin, Texas, United States, 75904
Actively Recruiting
92
Austin Heart PLLC
Round Rock, Texas, United States, 78681
Actively Recruiting
93
Austin Heart
San Marcos, Texas, United States, 78666
Actively Recruiting
94
Northwest Houston Heart Center
Tomball, Texas, United States, 77375
Actively Recruiting
95
Viva Heart and Vein
Tomball, Texas, United States, 77375
Actively Recruiting
96
TPMG Clinical Research
Newport News, Virginia, United States, 23606
Actively Recruiting
97
Chippenham Hospital
Richmond, Virginia, United States, 23225
Actively Recruiting
98
MultiCare Institute for Research and Innovation
Puyallup, Washington, United States, 98372
Actively Recruiting
99
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States, 98405
Actively Recruiting
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Research Team
R
Robin Barron-Nelson, RN, MSN
J
Jen Holt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network.
Alanna M Chamberlain, Yan Gong, Kathryn McAuliffe Shaw...
https://pubmed.ncbi.nlm.nih.gov/31020929