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Study Complete
Sponsor ID
20110118

Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated RiskFOURIER

Sponsor ID
20110118
Clinicaltrials.gov ID
NCT01764633
EUCTIS ID
N/A
EudraCT ID
2012-001398-97
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Study Details

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
27564
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 5 years

Secondary Outcome Measures

Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first

Timeframe: 5 Years

Time to cardiovascular death

Timeframe: 5 years

Time to death by any cause

Timeframe: 5 years

Time to first myocardial infarction

Timeframe: 5 years

Time to first stroke

Timeframe: 5 years

Time to first coronary revascularization

Timeframe: 5 years

Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first

Timeframe: 5 years

Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first

Timeframe: 5 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Selah, WA, United States, 98942
Status
Completed
Location
Research Site
Cary, NC, United States, 27518
Status
Completed
Location
Research Site
Pushkin, Russian Federation, 196601
Status
Recruiting
Location
Research Site
Aalborg, Denmark, 9000
Status
Recruiting
Location
Research Site
Aalst, Belgium, 9300
Status
Recruiting
Location
Research Site
Abington, PA, United States, 19001
Status
Completed
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Study Info
Age
40 - 85 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Feb 2013 - Nov 2016
    Inclusion and Exclusion Criteria
    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 low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (> 2.6 mmol/L) - Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
    Exclusion Criteria:
    - New York Heart Association (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