Phase 3
N=27,564
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01764633 ↗Enrolled (actual)
27,564
Serious AEs
24.8%
Results posted
Feb 2018
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Evolocumab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Nov 2016
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 |
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.
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). 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.