A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Elevated Lp(a) | Atherosclerotic Cardiovascular Disease (ASCVD)The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L).
* Meet criteria of either 2a or 2b:
2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.
2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.
Exclusion Criteria:
* Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, \< 90 days before screening.
* Have uncontrolled hypertension
* Have New York Heart Association class IV heart failure.
* Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
* Have severe renal failure, defined as
* Estimated glomerular rate (eGFR) \<15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
* Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening.
Study Location
Medical Arts Health Research Group
Medical Arts Health Research GroupPenticton, British Columbia
Canada
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Victoria Heart Institute Foundation
Victoria Heart Institute FoundationVictoria, British Columbia
Canada
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Care Access - Cape Breton
Care Access - Cape BretonSydney, Nova Scotia
Canada
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Cardio Health Clinical Trial - London
Cardio Health Clinical Trial - LondonLondon, Ontario
Canada
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Diex Recherche Joliette
Diex Recherche JolietteJoliette, Quebec
Canada
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Corcare
CorcareToronto, Ontario
Canada
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Diex Recherche Trois-Rivieres
Diex Recherche Trois-RivieresTrois-Rivieres, Quebec
Canada
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Fraser Clinical Trials Inc
Fraser Clinical Trials IncNew Westminster, British Columbia
Canada
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The Medical Arts Health Research Group
The Medical Arts Health Research GroupVancouver, British Columbia
Canada
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G A Research Associates
G A Research AssociatesMoncton, New Brunswick
Canada
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Milestone Research Inc.
Milestone Research Inc.London, Ontario
Canada
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Cardio Health Clinical Trial - St. Thomas
Cardio Health Clinical Trial - St. ThomasSt. Thomas, Ontario
Canada
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Viacar Recherche Clinique
Viacar Recherche CliniqueGreenfield Park, Quebec
Canada
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Centre de Medecine Metabolique de Lanaudiere (CMML)
Centre de Medecine Metabolique de Lanaudiere (CMML)Terrebonne, Quebec
Canada
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SMH Cardiology Clinical Trials
SMH Cardiology Clinical TrialsSurrey, British Columbia
Canada
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Discovery Clinical Services
Discovery Clinical ServicesVictoria, British Columbia
Canada
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Cardio Health Clinical Trial - Brampton
Cardio Health Clinical Trial - BramptonBrampton, Ontario
Canada
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North York Diagnostic and Cardiac Centre
North York Diagnostic and Cardiac CentreNorth York, Ontario
Canada
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Diabetes Heart Research Centre
Diabetes Heart Research CentreToronto, Ontario
Canada
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Clinique des Maladies Lipidiques de Québec
Clinique des Maladies Lipidiques de QuébecQuébec, Quebec
Canada
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ARC Biosystems
ARC BiosystemsVancouver, British Columbia
Canada
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Winnipeg Clinic
Winnipeg ClinicWinnipeg, Manitoba
Canada
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Premier Clinical Trial Network
Premier Clinical Trial NetworkHamilton, Ontario
Canada
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Oakville Cardiovascular Research LP
Oakville Cardiovascular Research LPOakville, Ontario
Canada
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Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
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Unité de Recherche Clinique du CISSS des Laurentides
Unité de Recherche Clinique du CISSS des LaurentidesSt-Jerome, Quebec
Canada
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- Study Sponsored By
- Eli Lilly and Company
- Participants Required
- More Information
- Study ID:
NCT06292013