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Clinical Trials List

Protocol Number20170625
NCT Number(ClinicalTrials.gov Identfier)NCT03872401

2019-05-02 - 2026-01-17

Phase III

Recruiting9

Terminated1

ICD-10I25.10

Atherosclerotic heart disease of native coronary artery without angina pectoris

ICD-9429.2

Cardiovascular disease, unspecified

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 黃金洲 Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-TE LEE Division of Endocrinology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王志鴻 Division of Cardiovascular Diseases
Hualien Tzu Chi Hospital

Co-Principal Investigator

  • 張懷仁 Division of Cardiovascular Diseases
  • 楊秋芬 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李貽恆 Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

  • 陳東藝 Division of Cardiovascular Diseases
  • 陳俊吉 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳炯仁 Division of Cardiovascular Diseases
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

  • 陳建仁 Division of Cardiovascular Diseases
  • 方修御 Division of Cardiovascular Diseases
  • 方志元 Division of Cardiovascular Diseases
  • 薛書凱 Division of Cardiovascular Diseases
  • 楊正旭 Division of Cardiovascular Diseases
  • 林振瑞 Division of Cardiovascular Diseases
  • 鄭正一 Division of Cardiovascular Diseases
  • 李建和 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃建寧 Division of Endocrinology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Chih Wang Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Coronary Heart Disease (CHD)

Objectives

Primary • To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first, in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy • To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first, in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy Secondary • To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for MI, ischemic stroke, or any ischemia-driven arterial revascularization in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy • To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for CHD death, MI, or any ischemia-driven arterial revascularization in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy

Test Drug

Repatha

Active Ingredient

Evolocumab

Dosage Form

Solution for Injection

Dosage

140

Endpoints

Primary Outcome Measures :
Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first.

Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first.

Secondary Outcome Measures :
Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to Cardiovascular Death, MI, or Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to Myocardial Infarction [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to CHD Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to Cardiovascular Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to All Cause of Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
Time to Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]

Inclution Criteria

Inclusion criteria:

Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L)
Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):

A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus

At least 1 high-risk feature

Exclusion Criteria

Exclusion criteria

MI or stroke prior to randomization
Coronary artery bypass grafting (CABG) ˂ 3 months prior to screening
Estimated glomerular filtration rate (eGFR) ˂ 15 mL/min/1.73 m²
Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)
Triglycerides ≥ 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV
Planned arterial revascularization

The Estimated Number of Participants

  • Taiwan

    185 participants

  • Global

    13000 participants

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