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

Dyslipidemia Clinical Trial

— FOURIER OLE  

Official title:

A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867813
• Other study ID #: 20130295
• Secondary ID: 2015-004780-36
• Status: Completed
• Phase: Phase 3
• Start date: September 2, 2016
• Est. completion date: March 21, 2022

Study information

• Verified date: March 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5035
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Jihlava
Czechia	Research Site	Liberec
Czechia	Research Site	Mohelnice
Czechia	Research Site	Ostrava
Czechia	Research Site	Ostrava-Dubina
Czechia	Research Site	Praha 2
Czechia	Research Site	Prerov
Czechia	Research Site	Pribram VIII
Czechia	Research Site	Znojmo
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Poland	Research Site	Bielsko-Biala
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Gdynia
Poland	Research Site	Gdynia
Poland	Research Site	Gizycko
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Nysa
Poland	Research Site	Olsztyn
Poland	Research Site	Plock
Poland	Research Site	Poznan
Poland	Research Site	Pszczyna
Poland	Research Site	Pulawy
Poland	Research Site	Ruda Slaska
Poland	Research Site	Skierniewice
Poland	Research Site	Staszow
Poland	Research Site	Swidnik
Poland	Research Site	Tarnow
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wloclawek
Poland	Research Site	Wroclaw
Poland	Research Site	Zamosc
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratov
Slovakia	Research Site	Kosice
Slovakia	Research Site	Svidnik
Ukraine	Research Site	Zaporizhzhya
United States	Research Site	Addison	Illinois
United States	Research Site	Athens	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Auburn	Maine
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bangor	Maine
United States	Research Site	Banning	California
United States	Research Site	Belleville	Illinois
United States	Research Site	Biddeford	Maine
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Burke	Virginia
United States	Research Site	Calabash	North Carolina
United States	Research Site	Camp Hill	Pennsylvania
United States	Research Site	Canton	Ohio
United States	Research Site	Chambersburg	Pennsylvania
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Maryland
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Cortlandt Manor	New York
United States	Research Site	Crystal River	Florida
United States	Research Site	Dayton	Ohio
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Dunwoody	Georgia
United States	Research Site	Elyria	Ohio
United States	Research Site	Evansville	Indiana
United States	Research Site	Falls Church	Virginia
United States	Research Site	Fargo	North Dakota
United States	Research Site	Federal Way	Washington
United States	Research Site	Gainesville	Georgia
United States	Research Site	Germantown	Tennessee
United States	Research Site	Grandville	Michigan
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Hammond	Louisiana
United States	Research Site	Haverhill	Massachusetts
United States	Research Site	Hickory	North Carolina
United States	Research Site	High Point	North Carolina
United States	Research Site	Hollywood	Florida
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indian Land	South Carolina
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jerseyville	Illinois
United States	Research Site	Kalispell	Montana
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kansas City	Kansas
United States	Research Site	Kerrville	Texas
United States	Research Site	Lansing	Michigan
United States	Research Site	Largo	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Layton	Utah
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Littleton	Colorado
United States	Research Site	Long Beach	California
United States	Research Site	Marion	Ohio
United States	Research Site	Memphis	Tennessee
United States	Research Site	Meridian	Idaho
United States	Research Site	Metairie	Louisiana
United States	Research Site	Miami	Florida
United States	Research Site	Moncks Corner	South Carolina
United States	Research Site	Monroe	Louisiana
United States	Research Site	Mooresville	North Carolina
United States	Research Site	Munster	Indiana
United States	Research Site	Muskegon	Michigan
United States	Research Site	Nashville	Tennessee
United States	Research Site	Natchitoches	Louisiana
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Port Richey	Florida
United States	Research Site	New Windsor	New York
United States	Research Site	New York	New York
United States	Research Site	Newton	Massachusetts
United States	Research Site	North Myrtle Beach	South Carolina
United States	Research Site	Oceanside	California
United States	Research Site	Oxnard	California
United States	Research Site	Palm Springs	California
United States	Research Site	Pawtucket	Rhode Island
United States	Research Site	Pensacola	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Plano	Texas
United States	Research Site	Ponte Vedra Beach	Florida
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Pryor	Oklahoma
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Roseville	California
United States	Research Site	Saginaw	Michigan
United States	Research Site	Saint Cloud	Minnesota
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Salisbury	Maryland
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Pedro	California
United States	Research Site	Sandusky	Ohio
United States	Research Site	Sarasota	Florida
United States	Research Site	Sarasota	Florida
United States	Research Site	Savannah	Georgia
United States	Research Site	Seattle	Washington
United States	Research Site	Slidell	Louisiana
United States	Research Site	Springfield	Ohio
United States	Research Site	Statesville	North Carolina
United States	Research Site	Suffolk	Virginia
United States	Research Site	Suwanee	Georgia
United States	Research Site	Tabor City	North Carolina
United States	Research Site	Tarzana	California
United States	Research Site	Toledo	Ohio
United States	Research Site	Torrance	California
United States	Research Site	Tullahoma	Tennessee
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Valley Village	California
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Waterloo	Iowa
United States	Research Site	West Jordan	Utah
United States	Research Site	West Seneca	New York
United States	Research Site	Wichita	Kansas
United States	Research Site	Wichita Falls	Texas
United States	Research Site	Williamsville	New York
United States	Research Site	Willoughby	Ohio
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Poland,  Russian Federation,  Slovakia,  Ukraine, 

References & Publications (2)

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 Feb 13. doi: 10.1161/CIRCULATIONAHA.122.063399. Online ahead of print. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   AmgenTrials clinical trials website