The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10,450
Administered orally
Administered orally
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
Time frame: Baseline up to End of Study (About 5.25 Years)
Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4
Time frame: Baseline, Week 4
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to Occurrence of All-Cause Mortality
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona, United States
NOT_YET_RECRUITINGAxsendo Clinical Research - Peak Heart & Vascular - Phoenix
Phoenix, Arizona, United States
NOT_YET_RECRUITINGClinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
NOT_YET_RECRUITINGSouthwest Kidney Institute - Surprise
Surprise, Arizona, United States
NOT_YET_RECRUITINGPima Heart
Tucson, Arizona, United States
NOT_YET_RECRUITINGNational Heart Institute
Beverly Hills, California, United States
NOT_YET_RECRUITINGJohn Muir Medical Center - Concord Campus
Concord, California, United States
RECRUITINGNeighborhood Healthcare Institute of Health
Escondido, California, United States
NOT_YET_RECRUITINGArk Clinical Research - Fountain Valley
Fountain Valley, California, United States
RECRUITINGThe Cardiovascular Center
Redding, California, United States
RECRUITING...and 699 more locations
Time frame: Baseline up to End of Study (About 5.25 Years)
Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin
Time frame: Predose through Week 96