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Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

NCT ID: NCT02867813

Last Updated: 2023-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5035 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-02

Study Completion Date

2022-03-21

Brief Summary

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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).

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Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer

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ASCVD Atherosclerotic Cardiovascular Disease Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor +1 more
NOT_YET_RECRUITING PHASE4

Detailed Description

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This is a multicenter, open-label extension study designed to assess the long-term safety of evolocumab in subjects who completed the FOURIER study,which is a randomized placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of FOURIER study.

Conditions

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Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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evolocumab (AMG 145)

All 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.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.

Interventions

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Evolocumab

subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Banning, California, United States

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Long Beach, California, United States

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Oceanside, California, United States

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Oxnard, California, United States

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Palm Springs, California, United States

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Roseville, California, United States

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San Diego, California, United States

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San Pedro, California, United States

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Tarzana, California, United States

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Torrance, California, United States

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Valley Village, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Crystal River, Florida, United States

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Daytona Beach, Florida, United States

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Hollywood, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Pensacola, Florida, United States

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Ponte Vedra Beach, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Dunwoody, Georgia, United States

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Gainesville, Georgia, United States

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Savannah, Georgia, United States

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Suwanee, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Meridian, Idaho, United States

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Addison, Illinois, United States

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Belleville, Illinois, United States

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Chicago, Illinois, United States

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Jerseyville, Illinois, United States

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Evansville, Indiana, United States

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Munster, Indiana, United States

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Iowa City, Iowa, United States

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Waterloo, Iowa, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Hammond, Louisiana, United States

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Metairie, Louisiana, United States

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Monroe, Louisiana, United States

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Natchitoches, Louisiana, United States

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Slidell, Louisiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Biddeford, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Salisbury, Maryland, United States

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Haverhill, Massachusetts, United States

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Newton, Massachusetts, United States

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Grandville, Michigan, United States

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Lansing, Michigan, United States

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Muskegon, Michigan, United States

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Saginaw, Michigan, United States

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Saint Cloud, Minnesota, United States

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Saint Paul, Minnesota, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Voorhees Township, New Jersey, United States

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Brooklyn, New York, United States

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Cortlandt Manor, New York, United States

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New Hyde Park, New York, United States

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New Windsor, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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West Seneca, New York, United States

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Williamsville, New York, United States

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Calabash, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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High Point, North Carolina, United States

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Mooresville, North Carolina, United States

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Statesville, North Carolina, United States

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Tabor City, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Elyria, Ohio, United States

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Marion, Ohio, United States

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Sandusky, Ohio, United States

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Springfield, Ohio, United States

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Toledo, Ohio, United States

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Willoughby, Ohio, United States

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Pryor, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Chambersburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Charleston, South Carolina, United States

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Moncks Corner, South Carolina, United States

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North Myrtle Beach, South Carolina, United States

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Old Point Station, South Carolina, United States

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Rapid City, South Dakota, United States

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Germantown, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Tullahoma, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kerrville, Texas, United States

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Plano, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Layton, Utah, United States

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West Jordan, Utah, United States

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Burke, Virginia, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Suffolk, Virginia, United States

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Federal Way, Washington, United States

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Seattle, Washington, United States

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Green Bay, Wisconsin, United States

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Brno, , Czechia

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Brno, , Czechia

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Brno, , Czechia

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Jihlava, , Czechia

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Liberec, , Czechia

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Mohelnice, , Czechia

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Ostrava, , Czechia

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Ostrava-Dubina, , Czechia

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Prague, , Czechia

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Pribram VIII, , Czechia

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Přerov, , Czechia

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Znojmo, , Czechia

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Békéscsaba, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Bielsko-Biala, , Poland

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Gdynia, , Poland

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Giżycko, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Nysa, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Pszczyna, , Poland

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Puławy, , Poland

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Płock, , Poland

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Ruda Śląska, , Poland

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Skierniewice, , Poland

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Staszów, , Poland

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Świdnik, , Poland

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Tarnów, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Włocławek, , Poland

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Zamość, , Poland

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Košice, , Slovakia

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Svidník, , Slovakia

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Zaporizhzhya, , Ukraine

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Countries

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United States Czechia Hungary Poland Russia Slovakia Ukraine

References

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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.

Reference Type BACKGROUND
PMID: 36031810 (View on PubMed)

Gaba 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.

Reference Type BACKGROUND
PMID: 36779348 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2015-004780-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20130295

Identifier Type: -

Identifier Source: org_study_id

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