Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

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)

ClinicalTrials.gov Identifier: NCT04873934

Novartis Reference Number: CKJX839A1US01

Last Update: May 03, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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,

Condition 
Acute Coronary Syndrome
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jun 24, 2021
Completion date 
Mar 20, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Inclisiran
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Drug
Inclisiran
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Drug
Inclisiran
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

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 patients 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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Bakersfield, 93308
California
United States
Novartis Investigative Site
Recruiting
Fresno, 93720
California
United States
Novartis Investigative Site
Recruiting
Mission Viejo, 92691
California
United States
Novartis Investigative Site
Recruiting
West Hills, 91307
California
United States
Novartis Investigative Site
Recruiting
Stamford, 06905
Connecticut
United States
Novartis Investigative Site
Recruiting
Daytona Beach, 32117
Florida
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33308
Florida
United States
Novartis Investigative Site
Recruiting
Arlington Heights, 60005
Illinois
United States
Novartis Investigative Site
Recruiting
Des Moines, 50314
Iowa
United States
Novartis Investigative Site
Recruiting
Salisbury, 21804
Maryland
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Jackson, 39216
Mississippi
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63136
Missouri
United States
Novartis Investigative Site
Recruiting
Albany, 12211
New York
United States
Novartis Investigative Site
Recruiting
Cooperstown, 13326
New York
United States
Novartis Investigative Site
Recruiting
Manhasset, 11030
New York
United States
Novartis Investigative Site
Recruiting
Rosedale, 11422
New York
United States
Novartis Investigative Site
Recruiting
Cary, 27511
North Carolina
United States
Novartis Investigative Site
Recruiting
Lenoir, 28645
North Carolina
United States
Novartis Investigative Site
Recruiting
Canton, 44710
Ohio
United States
Novartis Investigative Site
Recruiting
Bend, 97701
Oregon
United States
Novartis Investigative Site
Recruiting
Hillsboro, 97123
Oregon
United States
Novartis Investigative Site
Recruiting
Dallas, 75226
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77070
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77094
Texas
United States
Novartis Investigative Site
Recruiting
Winchester, 22601
Virginia
United States
Novartis Investigative Site
Recruiting
Tacoma, 98405
Washington
United States
Novartis Investigative Site
Recruiting
Bakersfield, 93308
California
United States
Novartis Investigative Site
Recruiting
Fresno, 93720
California
United States
Novartis Investigative Site
Recruiting
Mission Viejo, 92691
California
United States
Novartis Investigative Site
Recruiting
West Hills, 91307
California
United States
Novartis Investigative Site
Recruiting
Stamford, 06905
Connecticut
United States
Novartis Investigative Site
Recruiting
Daytona Beach, 32117
Florida
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33308
Florida
United States
Novartis Investigative Site
Recruiting
Arlington Heights, 60005
Illinois
United States
Novartis Investigative Site
Recruiting
Des Moines, 50314
Iowa
United States
Novartis Investigative Site
Recruiting
Salisbury, 21804
Maryland
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Jackson, 39216
Mississippi
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63136
Missouri
United States
Novartis Investigative Site
Recruiting
Albany, 12211
New York
United States
Novartis Investigative Site
Recruiting
Cooperstown, 13326
New York
United States
Novartis Investigative Site
Recruiting
Manhasset, 11030
New York
United States
Novartis Investigative Site
Recruiting
Rosedale, 11422
New York
United States
Novartis Investigative Site
Recruiting
Cary, 27511
North Carolina
United States
Novartis Investigative Site
Recruiting
Lenoir, 28645
North Carolina
United States
Novartis Investigative Site
Recruiting
Canton, 44710
Ohio
United States
Novartis Investigative Site
Recruiting
Bend, 97701
Oregon
United States
Novartis Investigative Site
Recruiting
Hillsboro, 97123
Oregon
United States
Novartis Investigative Site
Recruiting
Dallas, 75226
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77070
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77094
Texas
United States
Novartis Investigative Site
Recruiting
Winchester, 22601
Virginia
United States
Novartis Investigative Site
Recruiting
Tacoma, 98405
Washington
United States
Novartis Investigative Site
Recruiting
Bakersfield, 93308
California
United States
Novartis Investigative Site
Recruiting
Fresno, 93720
California
United States
Novartis Investigative Site
Recruiting
Mission Viejo, 92691
California
United States
Novartis Investigative Site
Recruiting
West Hills, 91307
California
United States
Novartis Investigative Site
Recruiting
Stamford, 06905
Connecticut
United States
Novartis Investigative Site
Recruiting
Daytona Beach, 32117
Florida
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33308
Florida
United States
Novartis Investigative Site
Recruiting
Arlington Heights, 60005
Illinois
United States
Novartis Investigative Site
Recruiting
Des Moines, 50314
Iowa
United States
Novartis Investigative Site
Recruiting
Salisbury, 21804
Maryland
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Jackson, 39216
Mississippi
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63136
Missouri
United States
Novartis Investigative Site
Recruiting
Albany, 12211
New York
United States
Novartis Investigative Site
Recruiting
Cooperstown, 13326
New York
United States
Novartis Investigative Site
Recruiting
Manhasset, 11030
New York
United States
Novartis Investigative Site
Recruiting
Rosedale, 11422
New York
United States
Novartis Investigative Site
Recruiting
Cary, 27511
North Carolina
United States
Novartis Investigative Site
Recruiting
Lenoir, 28645
North Carolina
United States
Novartis Investigative Site
Recruiting
Canton, 44710
Ohio
United States
Novartis Investigative Site
Recruiting
Bend, 97701
Oregon
United States
Novartis Investigative Site
Recruiting
Hillsboro, 97123
Oregon
United States
Novartis Investigative Site
Recruiting
Dallas, 75226
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77070
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77094
Texas
United States
Novartis Investigative Site
Recruiting
Winchester, 22601
Virginia
United States
Novartis Investigative Site
Recruiting
Tacoma, 98405
Washington
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]