Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
- Registration Number
- NCT04873934
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inclisiran with Usual Care Inclisiran Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
- Primary Outcome Measures
Name Time Method Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) Baseline and Day 330 Inclisiran compared to usual care in reducing LDL-C \[percent change\] at Day 330 (Year 1)
Percentage (%) achieving change in low-density lipoprotein cholesterol (LDL-C) to <70 mg/dL Baseline and Day 330 Inclisiran compared to usual care in achieving LDL-C reduction \<70 mg/dL \[percent achieved\] at Day 330 (Year 1)
- Secondary Outcome Measures
Name Time Method Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) Baseline to Day 330 Inclisiran compared to usual care in reducing LDL-C \[absolute change\] at Day 330 (Year 1)
Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit Baseline, Day 330 Inclisiran compared to usual care on average percent change from baseline in LDL-C levels after Day 90 and up to Day 330
Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit Baseline, Day 330 Inclisiran compared to usual care on average absolute change from baseline in LDL-C levels after Day 90 and up to Day 330
Achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no) Baseline, Day 330 Inclisiran compared to usual care on achieving ≥50% reduction from baseline to Day 330
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) Baseline, Day 330 Inclisiran compared to usual care on achieving LDL-C \<100 mg/dL (subset of LDL-C ≥100 mg/dL at baseline) in LDL-C \<55 mg/dL to Day 330
Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol Baseline and Day 330 Inclisiran compared to placebo in reducing Apo B, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) \[Lp(a)\], non-high density lipoprotein cholesterol (non-HDL-C), and total cholesterol over time
Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol Baseline and Day 330 Inclisiran compared to placebo in reducing Apo B, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) \[Lp(a)\], non-high density lipoprotein cholesterol (non-HDL-C), and total cholesterol over time
Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change) Baseline and Day 330 Inclisiran compared to usual care on intensity of lipid lowering therapy over time
Percentage of participants discontinuing statin therapy (i.e., no statin use ≥30 days before the end-of-study visit) Baseline and Day 330 Inclisiran compared to usual care on discontinuation of statin therapy from baseline to Day 330
Trial Locations
- Locations (88)
Northeast Arkansas Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Central Cardiology Medical Center
🇺🇸Bakersfield, California, United States
The Heart Group Cardiovascular Associates Inc
🇺🇸Fresno, California, United States
Mission Heritage Medical Group
🇺🇸Mission Viejo, California, United States
Northbay Clinical Research LLC
🇺🇸Santa Rosa, California, United States
Clinnova Research Solutions
🇺🇸Torrance, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Interv Cardiology Med Grp
🇺🇸West Hills, California, United States
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
Colorado Springs Cardiology
🇺🇸Colorado Springs, Colorado, United States
Colorado Heart and Vascular
🇺🇸Lakewood, Colorado, United States
Cardiology Ass of Fairfield County
🇺🇸Stamford, Connecticut, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
George Washington Univ Medical Ctr
🇺🇸Washington, District of Columbia, United States
Nova Clinical Research LLC
🇺🇸Bradenton, Florida, United States
Teradan Clinical trials LLC
🇺🇸Brandon, Florida, United States
Clearwater Cardiovascular and Interventional Consultants
🇺🇸Clearwater, Florida, United States
Cardiology Research Associates
🇺🇸Daytona Beach, Florida, United States
Holy Cross Hospital Inc
🇺🇸Fort Lauderdale, Florida, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
Inpatient Research Clinical LLC
🇺🇸Miami Lakes, Florida, United States
Reliant Medical Research
🇺🇸Miami, Florida, United States
Innovation Medical Group LLC
🇺🇸Palmetto Bay, Florida, United States
Cardiology Consultants
🇺🇸Pensacola, Florida, United States
Theia Clinical Research Ctrs LLC
🇺🇸Tampa, Florida, United States
Morehouse School Of Medicine
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Ellipsis Group
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Northwest Heart Clinical Rsrch LLC
🇺🇸Arlington Heights, Illinois, United States
AMITA Heart and Vascular Group
🇺🇸Hinsdale, Illinois, United States
Franciscan Health Services Research Center
🇺🇸Indianapolis, Indiana, United States
Cardiovascular Research Of Northwest Indiana, Llc
🇺🇸Munster, Indiana, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Midwest Heart and Vascular Spec
🇺🇸Overland Park, Kansas, United States
Tidal Health Peninsula Regional Inc
🇺🇸Salisbury, Maryland, United States
Sparrow Clincal Research Institute
🇺🇸Lansing, Michigan, United States
MidMichigan Physicians Group
🇺🇸Midland, Michigan, United States
St Marys of Ascension Research
🇺🇸Saginaw, Michigan, United States
Trinity Health Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Cardiology Associates of North MS
🇺🇸Tupelo, Mississippi, United States
St Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
Bryan LGH Heart Inst Intigrated Cardiology Group
🇺🇸Lincoln, Nebraska, United States
Meridian Clinical Research
🇺🇸Lincoln, Nebraska, United States
Advanced Heart Care, LLC
🇺🇸Bridgewater, New Jersey, United States
Cardiovas Assoc of Delaware Valley
🇺🇸Elmer, New Jersey, United States
Inspira Medical Cent Mullica Hill
🇺🇸Mullica Hill, New Jersey, United States
Capital Cardiology Associates
🇺🇸Albany, New York, United States
University At Buffalo
🇺🇸Buffalo, New York, United States
Bassett Medical Center
🇺🇸Cooperstown, New York, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Laurelton Heart Specialist PC
🇺🇸Rosedale, New York, United States
Cary Research Group
🇺🇸Cary, North Carolina, United States
Moses Cone Hospital-Lebauer CV Research Foundation
🇺🇸Greensboro, North Carolina, United States
Clinical Trials Of America LLC
🇺🇸Lenoir, North Carolina, United States
Pinehurst Medical Clinic
🇺🇸Pinehurst, North Carolina, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
St John Health System
🇺🇸Bartlesville, Oklahoma, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
University of Pittsburgh Medical Center HABOT
🇺🇸Erie, Pennsylvania, United States
Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Guthrie Clinic
🇺🇸Sayre, Pennsylvania, United States
Monument Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
Covenant Medical Group
🇺🇸Knoxville, Tennessee, United States
Baylor Scott and White Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Vilo Research Group LLC
🇺🇸Houston, Texas, United States
Texas Heart Medical Group
🇺🇸Houston, Texas, United States
UT Physicians Memorial Hermann
🇺🇸Houston, Texas, United States
Northwest Houston Cardiology PA
🇺🇸Houston, Texas, United States
West Houston Area Clinical Trial Consultants
🇺🇸Houston, Texas, United States
The Heart Institute of East Texas
🇺🇸Lufkin, Texas, United States
CardioVoyage LLC
🇺🇸McKinney, Texas, United States
Research Group of North Texas
🇺🇸Sunnyvale, Texas, United States
Tyler Cardiovascular Consultants
🇺🇸Tyler, Texas, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
York Clinical Research
🇺🇸Norfolk, Virginia, United States
Dominion Medical Associates
🇺🇸Richmond, Virginia, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
MultiCare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States