Back to resultsManagement of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome (V-INCEPTION)
Primary Purpose
Acute Coronary Syndrome
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inclisiran
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Hyperlipidemia, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Lipid lowering therapies
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.
Sites / Locations
- Novartis Investigative SiteRecruiting
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Inclisiran with Usual Care
Usual Care
Arm Description
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Usual Care Alone
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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)
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04873934
Brief Title
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
Acronym
V-INCEPTION
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Hyperlipidemia, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Lipid lowering therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inclisiran with Usual Care
Arm Type
Experimental
Arm Description
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care Alone
Intervention Type
Drug
Intervention Name(s)
Inclisiran
Other Intervention Name(s)
KJX839
Intervention Description
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Primary Outcome Measure Information:
Title
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)
Description
Inclisiran compared to usual care in reducing LDL-C [percent change] at Day 330 (Year 1)
Time Frame
Baseline and Day 330
Title
Percentage (%) achieving change in low-density lipoprotein cholesterol (LDL-C) to <70 mg/dl
Description
Inclisiran compared to usual care in achieving LDL-C reduction <70 mg/dl [percent achieved] at Day 330 (Year 1)
Time Frame
Baseline and Day 330
Secondary Outcome Measure Information:
Title
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C)
Description
Inclisiran compared to usual care in reducing LDL-C [absolute change] at Day 330 (Year 1)
Time Frame
Baseline to Day 330
Title
Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
Description
Inclisiran compared to usual care on average percent change from baseline in LDL-C levels after Day 90 and up to Day 330
Time Frame
Baseline, after Day 90 up to Day 330
Title
Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
Description
Inclisiran compared to usual care on average absolute change from baseline in LDL-C levels after Day 90 and up to Day 330
Time Frame
Baseline, after Day 90 up to Day 330
Title
Achieving ≥ 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no)
Description
Inclisiran compared to usual care on achieving ≥ 50% reduction from baseline in LDL-C after Day 90 and up to Day 330
Time Frame
Baseline, after Day 90 up to Day 330
Title
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)
Description
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
Time Frame
Baseline, after Day 90 up to Day 330
Title
Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
Description
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
Time Frame
Baseline and Day 330
Title
Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
Description
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
Time Frame
Baseline and Day 330
Title
Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change)
Description
Inclisiran compared to usual care on intensity of lipid lowering therapy over time
Time Frame
Baseline and Day 330
Title
Percentage of participants discontinuing statin therapy (i.e., no statin use ≥ 30 days before the end-of-study visit)
Description
Inclisiran compared to usual care on discontinuation of statin therapy from baseline to Day 330
Time Frame
Baseline and Day 330
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90277
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Midland
State/Province
Michigan
ZIP/Postal Code
48640
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Elmer
State/Province
New Jersey
ZIP/Postal Code
08318
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mullica Hill
State/Province
New Jersey
ZIP/Postal Code
08062
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Albany
State/Province
New York
ZIP/Postal Code
12211
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77017
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sunnyvale
State/Province
Texas
ZIP/Postal Code
75182
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23608
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23504
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
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