Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Purpose
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
- Percutaneous Coronary Intervention
- Peripheral Endovascular Intervention
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study. - Males or females ≥ 18 years of age - Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD - Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention
Exclusion Criteria
- 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 during the study - Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results - Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities - Patients taking prohibited therapies as listed in Section 6.6.3 - Pregnant or breast-feeding women
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Inclisiran Sodium |
Inclisiran sodium 300 mg subcutaneous injection |
|
|
Placebo Comparator Placebo |
Normal saline 1.5 ml subcutaneous injection |
|
Recruiting Locations
Alexander City, Alabama 35010
Huntsville, Alabama 35801
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
Beverly Hills, California 90211
Chula Vista, California 91911
Newport Beach, California 92663
Northridge, California 91325
Riverside, California 92501
San Diego, California 92123
San Diego, California 92123
Torrance, California 90502
Van Nuys, California 91406
Ventura, California 93030
West Hills, California 91307
Bridgeport, Connecticut 06610
Danbury, Connecticut 06810
Stamford, Connecticut 06305
Clearwater, Florida 33756
Clearwater, Florida 33756
Coral Gables, Florida 33134
Daytona Beach, Florida 32117
Largo, Florida 33777
Miami Lakes, Florida 33014
Panama City, Florida 32405
Port Charlotte, Florida 33948
Safety Harbor, Florida 34695
Tampa, Florida 33614
Gainesville, Georgia 30501
Peachtree City, Georgia 30269
Tucker, Georgia 30084
Elkhart, Indiana 46514
Richmond, Indiana 47374
West Des Moines, Iowa 50266
Overland Park, Kansas 66211
Owensboro, Kentucky 42303
Bossier City, Louisiana 71111
Covington, Louisiana 70433
New Orleans, Louisiana 70112
Shreveport, Louisiana 71103
West Monroe, Louisiana 71291
Bangor, Maine 04401
Lanham, Maryland 20706
Rockville, Maryland 20850
Salisbury, Maryland 21804
Silver Spring, Maryland 20904
Lansing, Michigan 48912
Midland, Michigan 48670
Rochester Hills, Michigan 48307
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Mankato, Minnesota 56001
Southaven, Mississippi 38671
Tupelo, Mississippi 38801
Grand Island, Nebraska 68803
Lincoln, Nebraska 68506
Lincoln, Nebraska 68526
Omaha, Nebraska 68114
Lebanon, New Hampshire 03756
Bridgewater, New Jersey 08807
Elmer, New Jersey 08318
Flemington, New Jersey 08822
Haddon Heights, New Jersey 08035
Pomona, New Jersey 08240
Sewell, New Jersey 08080
Albany, New York 12211
Buffalo, New York 14214
Buffalo, New York 14214
New York, New York 10029
Poughkeepsie, New York 12601
Staten Island, New York 10310
Asheville, North Carolina 28803
Charlotte, North Carolina 28204
Charlotte, North Carolina 28207
Fayetteville, North Carolina 28304
Morrisville, North Carolina 27560
Winston-Salem, North Carolina 27103
Canton, Ohio 44710
Springfield, Ohio 45505
Zanesville, Ohio 43701
Oklahoma City, Oklahoma 73135
Camp Hill, Pennsylvania 17011
Chambersburg, Pennsylvania 17201
Lancaster, Pennsylvania 17602
West Reading, Pennsylvania 19611
York, Pennsylvania 17403
Anderson, South Carolina 29621
Germantown, Tennessee 38138
Jackson, Tennessee 38301
Jackson, Tennessee 38305
Nashville, Tennessee 37203
Amarillo, Texas 79106
Amarillo, Texas 79124
Conroe, Texas 77384
Kingwood, Texas 77339
Lufkin, Texas 75904
McAllen, Texas 78504
Round Rock, Texas 78681
San Marcos, Texas 78666
Tomball, Texas 77375
Tomball, Texas 77375
Newport News, Virginia 23606
Richmond, Virginia 23225
Winchester, Virginia 22601
Puyallup, Washington 98372
Tacoma, Washington 98405
More Details
- Status
- Recruiting
- Sponsor
- Duke University
Detailed Description
CKJX839D1US04R is a pragmatic, randomized, double-blind, parallel group, placebo-controlled, multicenter, event-driven study evaluating inclisiran sodium 300 mg subcutaneous administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in participants presenting for elective or urgent percutaneous coronary or peripheral endovascular intervention (PCI or PVI). At the time of a successful revascularization procedure or up to 14 days following the procedure, participants will be randomized and administered the first dose of inclisiran or corresponding placebo in a 1:1 fashion, stratified by the type of index arterial revascularization procedure, either coronary (i.e., PCI) or lower extremity (i.e., PV). The enrollment population will be representative of typical patients in the US with atherosclerotic cardiovascular disease, either coronary artery disease (CAD) or peripheral artery disease (PAD), and the trial endpoints are designed to be scientifically relevant and clinically meaningful to patients, clinicians, and other persons involved in the care of cardiovascular patients. The trial is designed to also understand how inclisiran therapy can be implemented in real-world clinical practice settings. The expected enrollment of the trial is approximately 6,000 participants, randomized in a 1:1 fashion to receive inclisiran or placebo, within 14 days of successful percutaneous coronary or lower extremity peripheral endovascular intervention for symptomatic atherosclerotic cardiovascular disease (ASCVD). Inclisiran sodium or corresponding placebo will be administered by s.c. injection to participants presenting for percutaneous coronary or peripheral endovascular intervention, in addition to usual care according to their individual medical history. All participants randomized to the treatment arm will receive inclisiran in addition to usual care per their regular physician direction, and those participants randomized to placebo will receive matching placebo, as well as usual care treatment, according to their treating physician. Study duration is determined by event accrual consistent with the event-driven design, i.e., when approximately 2380 primary composite events have occurred and at least 50% of participants have at least 36 months of follow-up. Assuming 18 months of recruitment at a uniform rate, the last patients enrolled will have about 27 months of follow-up. Therefore, study duration should be approximately 4 years. The study is event-driven, and thus, all participants will be treated (or followed in the case of permanent discontinuation of study drug) until the End of Study visit. As such, the planned duration of treatment cannot be stipulated for an individual participant. The estimated maximum treatment period for an individual participant is approximately 45 months, and the mean treatment duration is expected to be approximately 36 months.