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

• Status: Completed
• Trial end date: 2016-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Evolocumab; Hydroxymethylglutaryl-CoA Reductase Inhibitors

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