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



Status:Completed
Conditions:High Cholesterol, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 85
Updated:2/17/2018
Start Date:February 8, 2013
End Date:November 11, 2016

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Trial Summary
Trial Overview
Inclusion Criteria

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

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.


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
We found this trial at
331
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Altoona, Pennsylvania 16602
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Ames, Iowa 50010
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Ann Arbor, Michigan 48109
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Annapolis, Maryland 21401
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Arlington, Texas 76017
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Augusta, Georgia 30912
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Aurora, Colorado 80045
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Austin, Texas 78744
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Aventura, Florida 33108
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Bangor, Maine 04402
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Banning, California 92220
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Baton Rouge, Louisiana 70809
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Belleville, Illinois 62220
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Boise, Idaho 83712
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Calabash, North Carolina 28467
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Camp Hill, Pennsylvania 17011
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Canton, Ohio 44718
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Charleston, South Carolina 29412
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Coeur D'Alene, Idaho 83814
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Colorado Springs, Colorado 80910
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Colorado Springs, Colorado 80910
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Columbia, Maryland 21044
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Columbia, Maryland 21044
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Columbia, Missouri 65201
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Covington, Louisiana 70433
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Dayton, Ohio 45409
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Daytona Beach, Florida 32117
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Dearborn, Michigan 48124
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Deerfield Beach, Florida 33442
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Delray Beach, Florida 33406
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Dunwoody, Georgia 30338
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Elizabeth, New Jersey 07202
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Encino, California 91436
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Escondido, California 92025
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Evansville, Indiana 47713
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Fall River, Massachusetts 02720
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Falls Church, Virginia 22042
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Fargo, North Dakota 58122
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