Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT01764633

First received: January 8, 2013

Last updated: July 26, 2016

Last verified: July 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2013

Last Updated Date

July 26, 2016

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

November 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization whichever occurs first. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization whichever occurs first.

Original Primary Outcome Measures ^ICMJE

Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first.

Change History

Complete list of historical versions of study NCT01764633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first
Time to cardiovascular death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to cardiovascular death
Time to death by any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to death by any cause
Time to first myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to first myocardial infarction
Time to first stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to first stroke
Time to first coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to first coronary revascularization
Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first
Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first

Original Secondary Outcome Measures ^ICMJE

Time to cardiovascular death, myocardial infarction, or stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first
Time to death by any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to death by any cause
Time to cardiovascular death or hospitalization for worsening heart failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to cardiovascular death or hospitalization for worsening heart failure, whichever occurs first
Time to ischemic fatal or non-fatal stroke or TIA [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

Official Title ^ICMJE

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Brief Summary

The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Dyslipidemia

Intervention ^ICMJE

Biological: Evolocumab (AMG 145)
Evolocumab (AMG 145)
Other: Placebo
Placebo
Drug: Effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin

Study Arm (s)

Experimental: Arm 1
Evolocumab (AMG 145) Q2W or QM plus effective statin dose
Interventions:
- Biological: Evolocumab (AMG 145)
- Drug: Effective statin therapy
Placebo Comparator: Arm 2
Placebo Q2W or QM plus effective statin dose
Interventions:
- Other: Placebo
- Drug: Effective statin therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

27564

Estimated Completion Date

November 2016

Estimated Primary Completion Date

November 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female ≥ 40 to ≤ 85 years of age
History of clinically evident cardiovascular disease at high risk for a recurrent event
Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mmol/L)
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

NYHA class III or IV, or last known left ventricular ejection fraction < 30%
Uncontrolled hypertension
Uncontrolled or recurrent ventricular tachycardia
Untreated hyperthyroidism or hypothyroidism
Homozygous familial hypercholesterolemia
LDL or plasma apheresis

Gender

Both

Ages

40 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01764633

Other Study ID Numbers ^ICMJE

20110118, 2014/01/004324

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Amgen

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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