Phase 3
Completed N=27,564
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Source: ClinicalTrials.gov NCT01764633 ↗Enrolled (actual)
27,564
Serious AEs
24.8%
Results posted
Feb 2018
Primary outcomePrimary: Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization — 3.11; 2.74; 6.01; 5.31 percentage of participants — p=< 0.0001
◆ Published Evidence
Highly cited
179citations · ~60 / year
Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE.
Summary
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.
Linked Publications (5)
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Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE.
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Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data.
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Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial.
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Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial.
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Efficacy and Safety of Very Low Achieved LDL Cholesterol in Patients With Previous Ischemic Stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization |
3.11; 2.74; 6.01; 5.31; 8.32; 7.25 | < 0.0001 sig |
| SECONDARY Time to Cardiovascular Death, Myocardial Infarction, or Stroke |
1.86; 1.65; 3.68; 3.10; 5.18; 4.29 | < 0.0001 sig |
| SECONDARY Time to Cardiovascular Death |
0.40; 0.39; 0.82; 0.79; 1.19; 1.20 | 0.6188 |
| SECONDARY Time to All Cause Death |
0.62; 0.55; 1.29; 1.26; 1.96; 1.94 | 0.5368 |
| SECONDARY Time to First Myocardial Infarction |
1.14; 1.06; 2.39; 1.90; 3.33; 2.55 | < 0.0001 sig |
| SECONDARY Time to First Stroke |
0.50; 0.31; 0.85; 0.70; 1.30; 1.05 | 0.0101 sig |
| SECONDARY Time to First Coronary Revascularization |
1.87; 1.60; 3.71; 3.13; 5.20; 4.16 | < 0.0001 sig |
| SECONDARY Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure |
0.79; 0.64; 1.35; 1.29; 1.99; 1.99 | 0.8179 |
| SECONDARY Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack |
0.61; 0.42; 1.05; 0.83; 1.52; 1.18 | 0.0035 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01764633) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.