Acute Coronary Syndrome Clinical Trial
— V-INCEPTIONOfficial 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)
| Verified date | June 2024 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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,
| Status | Active, not recruiting |
| Enrollment | 400 |
| Est. completion date | August 30, 2024 |
| Est. primary completion date | August 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Capital Cardiology Associates | Albany | New York |
| United States | Northwest Heart Clinical Rsrch LLC . | Arlington Heights | Illinois |
| United States | Ellipsis Group . | Atlanta | Georgia |
| United States | Emory University . | Atlanta | Georgia |
| United States | Morehouse School of Medicine | Atlanta | Georgia |
| United States | Northside Hospital . | Atlanta | Georgia |
| United States | Aurora Denver Cardiology Associates | Aurora | Colorado |
| United States | Central Cardiology Medical Center | Bakersfield | California |
| United States | St John Health System | Bartlesville | Oklahoma |
| United States | Bend Memorial Clinic Summit Health Research Dept | Bend | Oregon |
| United States | Grace Research LLC . | Bossier City | Louisiana |
| United States | Nova Clinical Research LLC . | Bradenton | Florida |
| United States | Teradan Clinical trials LLC | Brandon | Florida |
| United States | Advanced Heart Care, LLC . | Bridgewater | New Jersey |
| United States | University At Buffalo Research | Buffalo | New York |
| United States | Aultman Hospital | Canton | Ohio |
| United States | Cary Research Group | Cary | North Carolina |
| United States | Charleston Area Medical Center CTC CSPP100A2365 and E1 | Charleston | West Virginia |
| United States | TRIHEALTH Good Samarithan Hospital . | Cincinnati | Ohio |
| United States | Clearwater Cardiovascular and Interventional Consultants . | Clearwater | Florida |
| United States | Colorado Springs Cardiology | Colorado Springs | Colorado |
| United States | Johns Hopkins University | Columbia | Maryland |
| United States | Bassett Medical Center | Cooperstown | New York |
| United States | Baylor Scott and White Heart and Vascular Hospital | Dallas | Texas |
| United States | Methodist Dallas Medical Center . | Dallas | Texas |
| United States | Cardiology Research Associates | Daytona Beach | Florida |
| United States | Iowa Heart Center . | Des Moines | Iowa |
| United States | Cardiovas Assoc of Delaware Valley | Elmer | New Jersey |
| United States | University of Pittsburgh Medical Center HABOT . | Erie | Pennsylvania |
| United States | Holy Cross Hospital Inc . | Fort Lauderdale | Florida |
| United States | The Heart Group Cardiovascular Associates Inc | Fresno | California |
| United States | Cardiac and Vascular Institute | Gainesville | Florida |
| United States | Northshore University Health System . | Glenview | Illinois |
| United States | Moses Cone Hospital Lebauer CVRF Cone Health | Greensboro | North Carolina |
| United States | AMITA Heart and Vascular Group | Hinsdale | Illinois |
| United States | Northwest Houston Cardiology PA Horizons Clin Resrch Group | Houston | Texas |
| United States | Texas Heart Medical Group | Houston | Texas |
| United States | UT Physicians Memorial Hermann | Houston | Texas |
| United States | Vilo Research Group LLC | Houston | Texas |
| United States | West Houston Area Clinical Trial Consultants CLCZ696D2301 | Houston | Texas |
| United States | Longwood Research | Huntsville | Alabama |
| United States | Franciscan Health Services Research Center . | Indianapolis | Indiana |
| United States | Jackson Heart Clinic | Jackson | Mississippi |
| United States | Baptist Health Research Institute . | Jacksonville | Florida |
| United States | Jamaica Hospital Medical Center | Jamaica | New York |
| United States | Northeast Arkansas Baptist Clinic CLCZ696BUS05 | Jonesboro | Arkansas |
| United States | Western Michigan University Homer Stryker MD School of Medi Center for Clinical Research | Kalamazoo | Michigan |
| United States | Covenant Medical Group | Knoxville | Tennessee |
| United States | Colorado Heart and Vascular CLCZ696BUS08 | Lakewood | Colorado |
| United States | Lancaster General Health | Lancaster | Pennsylvania |
| United States | Sparrow Clincal Research Institute | Lansing | Michigan |
| United States | Clinical Trials Of America LLC . | Lenoir | North Carolina |
| United States | Bryan LGH Heart Inst Intigrated Cardiology Group | Lincoln | Nebraska |
| United States | Meridian Clinical Research | Lincoln | Nebraska |
| United States | The Heart Institute of East Texas | Lufkin | Texas |
| United States | Northwell Health . | Manhasset | New York |
| United States | CardioVoyage LLC Abo Auda Associates | McKinney | Texas |
| United States | Reliant Medical Research | Miami | Florida |
| United States | Inpatient Research Clinical LLC | Miami Lakes | Florida |
| United States | MidMichigan Physicians Group | Midland | Michigan |
| United States | Minneapolis Heart Institute . | Minneapolis | Minnesota |
| United States | Mission Heritage Medical Group | Mission Viejo | California |
| United States | IMC-Diagnostic and Medical Center | Mobile | Alabama |
| United States | Inspira Medical Cent Mullica Hill | Mullica Hill | New Jersey |
| United States | Cardiovascular Rea Of NW Ind, LlC | Munster | Indiana |
| United States | Intermountain Medical Center . | Murray | Utah |
| United States | TPMG Clinical Research . | Newport News | Virginia |
| United States | York Clinical Research | Norfolk | Virginia |
| United States | Midwest Heart and Vascular Spec | Overland Park | Kansas |
| United States | Innovation Medical Group LLC | Palmetto Bay | Florida |
| United States | Cardiology Consultants | Pensacola | Florida |
| United States | Pinehurst Medical Clinic | Pinehurst | North Carolina |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | Monument Health Clinical Research . | Rapid City | South Dakota |
| United States | Dominion Medical Associates | Richmond | Virginia |
| United States | Carilion Clinic . | Roanoke | Virginia |
| United States | Laurelton Heart Specialist PC | Rosedale | New York |
| United States | St Marys of Ascension Research | Saginaw | Michigan |
| United States | CentraCare Heart and Vascular Ctr | Saint Cloud | Minnesota |
| United States | St Louis Heart and Vascular . | Saint Louis | Missouri |
| United States | Tidal Health Peninsula Regional Inc . | Salisbury | Maryland |
| United States | Northbay Clinical Research LLC | Santa Rosa | California |
| United States | Guthrie Clinic | Sayre | Pennsylvania |
| United States | Cox Health . | Springfield | Missouri |
| United States | Cardiology Ass of Fairfield County | Stamford | Connecticut |
| United States | Research Group of North Texas | Sunnyvale | Texas |
| United States | MultiCare Institute for Research and Innovation . | Tacoma | Washington |
| United States | Theia Clinical Research Ctrs LLC | Tampa | Florida |
| United States | University of Toledo . | Toledo | Ohio |
| United States | Clinnova Research Solutions | Torrance | California |
| United States | Harbor-UCLA Medical Center The Lindquist Institute | Torrance | California |
| United States | Revival Research Institute . | Troy | Michigan |
| United States | Cardiology Associates of North MS | Tupelo | Mississippi |
| United States | Tyler Cardiovascular Consultants | Tyler | Texas |
| United States | George Washington Univ Medical Ctr | Washington | District of Columbia |
| United States | Washington Hospital Center Medstar | Washington | District of Columbia |
| United States | Interv Cardiology Med Grp | West Hills | California |
| United States | Selma Medical Associates | Winchester | Virginia |
| United States | Wake Forest U of Health Sciences | Winston-Salem | North Carolina |
| United States | Trinity Health Michigan Heart . | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) | Inclisiran compared to usual care in reducing LDL-C [percent change] at Day 330 (Year 1) | Baseline and Day 330 | |
| Primary | Percentage (%) achieving change in low-density lipoprotein cholesterol (LDL-C) to <70 mg/dl | Inclisiran compared to usual care in achieving LDL-C reduction <70 mg/dl [percent achieved] at Day 330 (Year 1) | Baseline and Day 330 | |
| Secondary | Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) | Inclisiran compared to usual care in reducing LDL-C [absolute change] at Day 330 (Year 1) | Baseline to Day 330 | |
| Secondary | Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit | Inclisiran compared to usual care on average percent change from baseline in LDL-C levels after Day 90 and up to Day 330 | Baseline, after Day 90 up to Day 330 | |
| Secondary | Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit | Inclisiran compared to usual care on average absolute change from baseline in LDL-C levels after Day 90 and up to Day 330 | Baseline, after Day 90 up to Day 330 | |
| Secondary | Achieving = 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no) | Inclisiran compared to usual care on achieving = 50% reduction from baseline in LDL-C after Day 90 and up to Day 330 | Baseline, after Day 90 up to Day 330 | |
| Secondary | 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) | Inclisiran compared to usual care on achieving LDL-C < 100 mg/dL (subset of LDL-C = 100 mg/dL at baseline) and LDL-C <55 mg/dl after Day 90 and up to Day 330 | Baseline, after Day 90 up to Day 330 | |
| Secondary | Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol | 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 | Baseline and Day 330 | |
| Secondary | Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol | 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 | Baseline and Day 330 | |
| Secondary | Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change) | Inclisiran compared to usual care on intensity of lipid lowering therapy over time | Baseline and Day 330 | |
| Secondary | Percentage of participants discontinuing statin therapy (i.e., no statin use = 30 days before the end-of-study visit) | Inclisiran compared to usual care on discontinuation of statin therapy from baseline to Day 330 | Baseline and Day 330 |
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