Clinical trial NCT04873934: Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
Official title: A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome (VICTORION-INCEPTION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Hyperlipidemia
Atherosclerotic Cardiovascular Disease
Hypercholesterolemia
Lipid lowering therapies
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

Detailed description: The purpose of this study is to assess the effect on LDL-C of implementation of a systematic LDL-C management care pathway that includes initiation of inclisiran compared to usual care without inclisiran in participants with a recent hospitalization (inpatient/outpatient) for an acute coronary syndrome (ACS) with LDL-cholesterol ≥70 mg/dL despite receiving statin therapy.

Eligibility criteria: Inclusion Criteria:

* Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
* Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
* Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening
* Calculated glomerular filtration rate \>20 mL/min by estimated glomerular filtration rate (eGFR)
* Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose

Exclusion Criteria:

* New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction \<25%.
* Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
* Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.
* Planned use of other investigational products or devices during the course of the study.
* Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
* Recurrent ACS event within 2 weeks prior to randomization.
* Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.

Primary outcomes:
measure: Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline and Day 330
measure: Percentage (%) achieving change in low-density lipoprotein cholesterol (LDL-C) to <70 mg/dL
timeFrame: Baseline and Day 330
Secondary outcomes:
measure: Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline to Day 330
measure: Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
timeFrame: Baseline, Day 330
measure: Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
timeFrame: Baseline, Day 330
measure: Achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no)
timeFrame: Baseline, Day 330
measure: Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) targets (LDL-C <100 mg/dL among the subset of participants with LDL-C ≥100 mg/dL at baseline, and LDL-C <55 mg/dL)
timeFrame: Baseline, Day 330
measure: Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
timeFrame: Baseline and Day 330
measure: Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
timeFrame: Baseline and Day 330
measure: Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change)
timeFrame: Baseline and Day 330
measure: Percentage of participants discontinuing statin therapy (i.e., no statin use ≥30 days before the end-of-study visit)
timeFrame: Baseline and Day 330
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Northeast Arkansas Baptist Clinic
state: Arkansas
city: Bakersfield
country: United States
facility: Central Cardiology Medical Center
state: California
city: Fresno
country: United States
facility: The Heart Group Cardiovascular Associates Inc
state: California
city: Mission Viejo
country: United States
facility: Mission Heritage Medical Group
state: California
city: Santa Rosa
country: United States
facility: Northbay Clinical Research LLC
state: California
city: Torrance
country: United States
facility: Clinnova Research Solutions
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: West Hills
country: United States
facility: Interv Cardiology Med Grp
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiology
state: Colorado
city: Lakewood
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Stamford
country: United States
facility: Cardiology Ass of Fairfield County
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: George Washington Univ Medical Ctr
state: District of Columbia
city: Bradenton
country: United States
facility: Nova Clinical Research LLC
state: Florida
city: Brandon
country: United States
facility: Teradan Clinical trials LLC
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Daytona Beach
country: United States
facility: Cardiology Research Associates
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinical LLC
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Group LLC
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants
state: Florida
city: Tampa
country: United States
facility: Theia Clinical Research Ctrs LLC
state: Florida
city: Atlanta
country: United States
facility: Morehouse School Of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Ellipsis Group
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Heart Clinical Rsrch LLC
state: Illinois
city: Hinsdale
country: United States
facility: AMITA Heart and Vascular Group
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Services Research Center
state: Indiana
city: Munster
country: United States
facility: Cardiovascular Research Of Northwest Indiana, Llc
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Spec
state: Kansas
city: Salisbury
country: United States
facility: Tidal Health Peninsula Regional Inc
state: Maryland
city: Lansing
country: United States
facility: Sparrow Clincal Research Institute
state: Michigan
city: Midland
country: United States
facility: MidMichigan Physicians Group
state: Michigan
city: Saginaw
country: United States
facility: St Marys of Ascension Research
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Center
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North MS
state: Mississippi
city: Saint Louis
country: United States
facility: St Louis Heart and Vascular
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Inst Intigrated Cardiology Group
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Bridgewater
country: United States
facility: Advanced Heart Care, LLC
state: New Jersey
city: Elmer
country: United States
facility: Cardiovas Assoc of Delaware Valley
state: New Jersey
city: Mullica Hill
country: United States
facility: Inspira Medical Cent Mullica Hill
state: New Jersey
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: Buffalo
country: United States
facility: University At Buffalo
state: New York
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Rosedale
country: United States
facility: Laurelton Heart Specialist PC
state: New York
city: Cary
country: United States
facility: Cary Research Group
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Hospital-Lebauer CV Research Foundation
state: North Carolina
city: Lenoir
country: United States
facility: Clinical Trials Of America LLC
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Bartlesville
country: United States
facility: St John Health System
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Erie
country: United States
facility: University of Pittsburgh Medical Center HABOT
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic
state: Pennsylvania
city: Rapid City
country: United States
facility: Monument Health Clinical Research
state: South Dakota
city: Knoxville
country: United States
facility: Covenant Medical Group
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott and White Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Vilo Research Group LLC
state: Texas
city: Houston
country: United States
facility: Texas Heart Medical Group
state: Texas
city: Houston
country: United States
facility: UT Physicians Memorial Hermann
state: Texas
city: Houston
country: United States
facility: Northwest Houston Cardiology PA
state: Texas
city: Houston
country: United States
facility: West Houston Area Clinical Trial Consultants
state: Texas
city: Lufkin
country: United States
facility: The Heart Institute of East Texas
state: Texas
city: McKinney
country: United States
facility: CardioVoyage LLC
state: Texas
city: Sunnyvale
country: United States
facility: Research Group of North Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Norfolk
country: United States
facility: York Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: