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Further Cardiovascular Outcom...

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

Last Updated: 2024-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

27564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-08

Study Completion Date

2016-11-11

Brief Summary

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Evolocumab

Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Interventions

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Evolocumab

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Intervention Type BIOLOGICAL

Placebo

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Intervention Type DRUG

Other Intervention Names

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AMG 145 Repatha

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers