RECRUITING

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

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Conditions

Cardiovascular DiseaseOlpasiranAMG 890Coronary heart diseaseCHDMyocardial infarctionCoronary revascularization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).

Official Title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)

Quick Facts

Study Start:2025-09-19
Study Completion:2031-10-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07136012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 105 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥50 years
  2. * Lp(a)≥ 200 nmol/L during screening
  3. * Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
  1. * Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
  2. * Prior or planned arterial revascularization
  3. * History of major bleeding disorder

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Advanced Cardiovascular LLC
Alexander City, Alabama, 35010
United States
Eastern Shore Research Institute
Fairhope, Alabama, 36532
United States
Heart Center Research LLC
Huntsville, Alabama, 35801
United States
CB Flock Research Corporation
Mobile, Alabama, 36608
United States
Eclipse Clinical Research
Tucson, Arizona, 85745
United States
310 Clinical Research
Inglewood, California, 90301
United States
Valley Clinical Trials
Northridge, California, 91325
United States
Clinical Trials Research - Sacramento
Roseville, California, 95661
United States
Acclaim Clinical Research
San Diego, California, 92120
United States
Diablo Clinical Research
Walnut Creek, California, 94598
United States
Focus Clinical Research
West Hills, California, 91307
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308
United States
East Coast Institute for Research, LLC
Lake City, Florida, 32055
United States
Columbus Clinical Services LLC
Miami, Florida, 33125
United States
Ocala Cardiovascular Research
Ocala, Florida, 34471
United States
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174
United States
East Coast Institute for Research
Canton, Georgia, 30114
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714
United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
United States
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
United States
Ima Clinical Research
Monroe, Louisiana, 71201
United States
Metropolitan Cardiovascular Consultants LLC
Beltsville, Maryland, 20705
United States
Advanced Cardiology Associates
Rochester Hills, Michigan, 48307
United States
Excel Clinical Research
Las Vegas, Nevada, 89109
United States
American Institute of Medical Research
Las Vegas, Nevada, 89123
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Accellacare Research of Wilmington
Wilmington, North Carolina, 28401
United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45219
United States
K and R Research
Marion, Ohio, 43302
United States
Accellacare Charleston
Mount Pleasant, South Carolina, 29464
United States
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, 29301
United States
Alliance for Multispecialty Research Knoxville
Knoxville, Tennessee, 37909
United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
United States
PharmaTex Research, LLC
Amarillo, Texas, 79106
United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731
United States
Ima Clinical Research
Austin, Texas, 78745
United States
Zenos Clinical Research
Dallas, Texas, 75230
United States
Vital Heart and Vein
Humble, Texas, 77338
United States
Epic Clinical Research
Lewisville, Texas, 75057
United States
Texas Institute of Cardiology
McKinney, Texas, 75071
United States
Ima Clinical Research San Antonio
San Antonio, Texas, 78229
United States
Carient Heart and Vascular
Manassas, Virginia, 20109
United States
Tidewater Physicians Multispecialty Group Clinical Research
Newport News, Virginia, 23606
United States
Alliance for Multispecialty Research Norfolk
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-19
Study Completion Date2031-10-18

Study Record Updates

Study Start Date2025-09-19
Study Completion Date2031-10-18

Terms related to this study

Keywords Provided by Researchers

  • Olpasiran
  • AMG 890
  • Coronary heart disease
  • CHD
  • Myocardial infarction
  • Coronary revascularization

Additional Relevant MeSH Terms

  • Cardiovascular Disease