Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06909565

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Led by Duke University · Updated on 2026-05-12

6000

Participants Needed

96

Research Sites

227 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

N

Novartis Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Signed informed consent obtained prior to participation
  • Male or female aged 18 years or older
  • Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic coronary artery disease (CAD) or peripheral artery disease (PAD)
  • Patients undergoing planned staged interventions are eligible only after the last planned intervention
Not Eligible

You will not qualify if you...

  • Planned future PCI or PVI
  • Current or planned use of an open-label PCSK9 inhibitor during the study
  • Any prior treatment with inclisiran
  • Active or planned participation in another clinical study involving investigational drugs or devices
  • Serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other conditions that would interfere with participation or affect results
  • Any other reason deemed by the investigator that would make participation unsuitable including safety or protocol adherence concerns
  • Use of prohibited therapies as listed in study section 6.6.3
  • Pregnant or breast-feeding women

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 96 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

Advanced Heart Care LLC

Bridgewater, New Jersey, United States, 08807

Actively Recruiting

56

Cardiovascular Associates of the Delaware Valley

Elmer, New Jersey, United States, 08318

Actively Recruiting

57

Advanced Heart and Vascular Institute Of Hunterdon

Flemington, New Jersey, United States, 08822

Actively Recruiting

58

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States, 08035

Actively Recruiting

59

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States, 08240

Actively Recruiting

60

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, United States, 08080

Actively Recruiting

61

Sisters of Charity Hospital

Buffalo, New York, United States, 14214

Actively Recruiting

62

Trinity Medical WNY, PC

Buffalo, New York, United States, 14214

Actively Recruiting

63

Mount Sinai School of Medicine

New York, New York, United States, 10029

Actively Recruiting

64

Hudson Valley Cardiovascular Practice PC

Poughkeepsie, New York, United States, 12601

Actively Recruiting

65

Hudson Valley Cardiovascular Practice, PC

Poughkeepsie, New York, United States, 12601

Actively Recruiting

66

Richmond University Medical Center

Staten Island, New York, United States, 10310

Actively Recruiting

67

Asheville Cardiology Associates Research Department

Asheville, North Carolina, United States, 28803

Actively Recruiting

68

Mecklenburg Heart Specialists

Charlotte, North Carolina, United States, 28207

Actively Recruiting

69

Javara Inc.

Fayetteville, North Carolina, United States, 28304

Actively Recruiting

70

Duke Cardiology

Morrisville, North Carolina, United States, 27560

Actively Recruiting

71

Aultman Hospital

Canton, Ohio, United States, 44710

Actively Recruiting

72

Heart House Research Foundation LLC

Springfield, Ohio, United States, 45505

Actively Recruiting

73

Genesis HealthCare System

Zanesville, Ohio, United States, 43701

Actively Recruiting

74

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, United States, 73135

Actively Recruiting

75

Capital Area Research LLC

Camp Hill, Pennsylvania, United States, 17011

Actively Recruiting

76

Wellspan Chambersburg Hospital

Chambersburg, Pennsylvania, United States, 17201

Actively Recruiting

77

Cardiology Associates of West Reading

West Reading, Pennsylvania, United States, 19611

Actively Recruiting

78

WellSpan Heart and Vascular Research

York, Pennsylvania, United States, 17403

Actively Recruiting

79

AnMed Health Medical Center

Anderson, South Carolina, United States, 29621

Actively Recruiting

80

Stern Cardiovascular Center

Germantown, Tennessee, United States, 38138

Actively Recruiting

81

Apex Research Foundation, LLC

Jackson, Tennessee, United States, 38301

Actively Recruiting

82

TriStar Centennial Medical Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

83

PharmaTex Research

Amarillo, Texas, United States, 79106

Actively Recruiting

84

Amarillo Heart Clinical Research Institute, Inc.

Amarillo, Texas, United States, 79124

Actively Recruiting

85

Austin Heart

Austin, Texas, United States, 78705

Actively Recruiting

86

Javara inc.

Conroe, Texas, United States, 77384

Actively Recruiting

87

Texas Cardiology Associates of Houston

Kingwood, Texas, United States, 77339

Actively Recruiting

88

Heart Institute of East Texas

Lufkin, Texas, United States, 75904

Actively Recruiting

89

Austin Heart PLLC

Round Rock, Texas, United States, 78681

Actively Recruiting

90

Austin Heart

San Marcos, Texas, United States, 78666

Actively Recruiting

91

Northwest Houston Heart Center

Tomball, Texas, United States, 77375

Actively Recruiting

92

Viva Heart and Vein

Tomball, Texas, United States, 77375

Actively Recruiting

93

TPMG Clinical Research

Newport News, Virginia, United States, 23606

Actively Recruiting

94

Chippenham Hospital

Richmond, Virginia, United States, 23225

Actively Recruiting

95

MultiCare Institute for Research and Innovation

Puyallup, Washington, United States, 98372

Actively Recruiting

96

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

CONTACT

J

Jen Holt

CONTACT

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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