Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
FOURIER OLE
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
2 other identifiers
interventional
5,035
7 countries
198
Brief Summary
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2016
Longer than P75 for phase_3
198 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedStudy Start
First participant enrolled
September 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedResults Posted
Study results publicly available
February 28, 2023
CompletedApril 7, 2023
March 1, 2023
5.6 years
July 20, 2016
February 2, 2023
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced an Adverse Event
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Up to 5 years
Secondary Outcomes (2)
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Study Arms (1)
evolocumab (AMG 145)
EXPERIMENTALAll subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference.
Interventions
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Eligibility Criteria
You may qualify if:
- Subject has provided informed consent before initiation of any study-specific activities/procedures
- Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.
You may not qualify if:
- Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
- Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
- Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
- Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
- Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
- Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (198)
Research Site
Birmingham, Alabama, 35294, United States
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Huntsville, Alabama, 35801, United States
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Phoenix, Arizona, 85018, United States
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Banning, California, 92220, United States
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Long Beach, California, 90807, United States
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Oceanside, California, 92056, United States
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Oxnard, California, 93030, United States
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Palm Springs, California, 92262, United States
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Roseville, California, 95661, United States
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San Diego, California, 92161, United States
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San Pedro, California, 90732, United States
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Tarzana, California, 91356, United States
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Torrance, California, 90502, United States
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Valley Village, California, 91607, United States
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Aurora, Colorado, 80012, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80218, United States
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Littleton, Colorado, 80120, United States
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Boynton Beach, Florida, 33472, United States
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Clearwater, Florida, 33756, United States
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Crystal River, Florida, 34429, United States
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Daytona Beach, Florida, 32117, United States
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Hollywood, Florida, 33021, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32216, United States
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Largo, Florida, 33777, United States
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Miami, Florida, 33173, United States
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New Port Richey, Florida, 34653, United States
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Pensacola, Florida, 32501, United States
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Ponte Vedra Beach, Florida, 32081, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34232, United States
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Sarasota, Florida, 34239, United States
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St. Petersburg, Florida, 33713, United States
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Athens, Georgia, 30606, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30909, United States
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Dunwoody, Georgia, 30338, United States
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Gainesville, Georgia, 30501, United States
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Savannah, Georgia, 31406, United States
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Suwanee, Georgia, 30024, United States
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Coeur d'Alene, Idaho, 83814, United States
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Meridian, Idaho, 83642, United States
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Addison, Illinois, 60101, United States
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Belleville, Illinois, 62220, United States
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Chicago, Illinois, 60616, United States
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Jerseyville, Illinois, 62052, United States
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Evansville, Indiana, 47714, United States
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Munster, Indiana, 46321, United States
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Iowa City, Iowa, 52242, United States
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Waterloo, Iowa, 50702, United States
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Kansas City, Kansas, 66160, United States
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Wichita, Kansas, 67203, United States
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Lexington, Kentucky, 40503, United States
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Hammond, Louisiana, 70403, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71201, United States
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Natchitoches, Louisiana, 71457, United States
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Slidell, Louisiana, 70458, United States
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Auburn, Maine, 04210, United States
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Bangor, Maine, 04401, United States
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Biddeford, Maine, 04005, United States
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Baltimore, Maryland, 21204, United States
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Columbia, Maryland, 21044, United States
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Salisbury, Maryland, 21804, United States
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Haverhill, Massachusetts, 01830, United States
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Newton, Massachusetts, 02459, United States
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Grandville, Michigan, 49418, United States
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Lansing, Michigan, 48912, United States
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Muskegon, Michigan, 49444, United States
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Saginaw, Michigan, 48601, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Paul, Minnesota, 55102, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64128, United States
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St Louis, Missouri, 63128, United States
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Kalispell, Montana, 59901, United States
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Lincoln, Nebraska, 68506, United States
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Las Vegas, Nevada, 89148, United States
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Voorhees Township, New Jersey, 08043, United States
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Brooklyn, New York, 11206, United States
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Cortlandt Manor, New York, 10567, United States
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New Hyde Park, New York, 11042, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10029, United States
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Rochester, New York, 14609, United States
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West Seneca, New York, 14224, United States
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Williamsville, New York, 14221, United States
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Calabash, North Carolina, 28467, United States
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Charlotte, North Carolina, 28204, United States
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Greensboro, North Carolina, 27408, United States
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Hickory, North Carolina, 28601, United States
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High Point, North Carolina, 27262, United States
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Mooresville, North Carolina, 28117, United States
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Statesville, North Carolina, 28625, United States
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Tabor City, North Carolina, 28463, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58122, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45219, United States
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Columbus, Ohio, 43201, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45414, United States
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Elyria, Ohio, 44035, United States
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Marion, Ohio, 43302, United States
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Sandusky, Ohio, 44870, United States
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Springfield, Ohio, 45505, United States
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Toledo, Ohio, 43615, United States
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Willoughby, Ohio, 44094, United States
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Pryor, Oklahoma, 74361, United States
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Tulsa, Oklahoma, 74133, United States
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Portland, Oregon, 97225, United States
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Camp Hill, Pennsylvania, 17011, United States
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Chambersburg, Pennsylvania, 17201, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Pawtucket, Rhode Island, 02860, United States
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Charleston, South Carolina, 29407, United States
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Moncks Corner, South Carolina, 29461, United States
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North Myrtle Beach, South Carolina, 29582, United States
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Old Point Station, South Carolina, 29707, United States
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Rapid City, South Dakota, 57701, United States
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Germantown, Tennessee, 38138, United States
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Memphis, Tennessee, 38104, United States
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Nashville, Tennessee, 37203, United States
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Tullahoma, Tennessee, 37388, United States
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Austin, Texas, 78758, United States
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Houston, Texas, 77025, United States
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Houston, Texas, 77030, United States
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Kerrville, Texas, 78028, United States
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Plano, Texas, 75023, United States
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Plano, Texas, 75024, United States
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San Antonio, Texas, 78229, United States
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Wichita Falls, Texas, 76301, United States
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Layton, Utah, 84041, United States
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West Jordan, Utah, 84088, United States
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Burke, Virginia, 22015, United States
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Falls Church, Virginia, 22042, United States
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Richmond, Virginia, 23294, United States
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Suffolk, Virginia, 23435, United States
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Federal Way, Washington, 98003, United States
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Seattle, Washington, 98195, United States
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Green Bay, Wisconsin, 54301, United States
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Brno, 603 00, Czechia
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Brno, 625 00, Czechia
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Brno, 638 00, Czechia
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Jihlava, 586 33, Czechia
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Liberec, 460 63, Czechia
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Mohelnice, 789 85, Czechia
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Ostrava, 728 80, Czechia
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Ostrava-Dubina, 700 30, Czechia
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Prague, 128 08, Czechia
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Pribram VIII, 261 01, Czechia
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Přerov, 750 02, Czechia
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Znojmo, 669 02, Czechia
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Békéscsaba, 5600, Hungary
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Miskolc, 3529, Hungary
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Nyíregyháza, 4400, Hungary
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Bielsko-Biala, 43-316, Poland
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Bydgoszcz, 85-094, Poland
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Gdansk, 80-542, Poland
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Gdynia, 81-402, Poland
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Gdynia, 81-472, Poland
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Giżycko, 11-500, Poland
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Katowice, 40-084, Poland
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Kielce, 25-020, Poland
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Krakow, 30-082, Poland
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Krakow, 31-202, Poland
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Krakow, 31-216, Poland
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Lodz, 91-347, Poland
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Lublin, 20-857, Poland
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Nysa, 48-300, Poland
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Olsztyn, 10-010, Poland
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Poznan, 61-853, Poland
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Pszczyna, 43-200, Poland
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Puławy, 24-100, Poland
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Płock, 09-402, Poland
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Ruda Śląska, 41-709, Poland
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Skierniewice, 96-100, Poland
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Staszów, 28-200, Poland
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Świdnik, 21-040, Poland
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Tarnów, 33-100, Poland
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Torun, 87-100, Poland
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Warsaw, 02-097, Poland
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Warsaw, 02-507, Poland
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Warsaw, 04-628, Poland
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Wroclaw, 50-349, Poland
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Włocławek, 87-800, Poland
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Zamość, 22-400, Poland
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Moscow, 129090, Russia
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Saint Petersburg, 192289, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 199106, Russia
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Saratov, 410054, Russia
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Košice, 040 22, Slovakia
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Svidník, 089 01, Slovakia
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Zaporizhzhya, 69600, Ukraine
Related Publications (2)
O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
PMID: 36031810BACKGROUNDGaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
PMID: 36779348BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
August 16, 2016
Study Start
September 2, 2016
Primary Completion
March 21, 2022
Study Completion
March 21, 2022
Last Updated
April 7, 2023
Results First Posted
February 28, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request