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Clinical Trials List

Protocol Number20180244
NCT Number(ClinicalTrials.gov Identfier)NCT05581303
Active

2023-03-01 - 2027-04-30

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 Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    IQVIA

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator JUN-SING WANG Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases

Co-Principal Investigator

  • 洪大川 Division of Cardiovascular Diseases
  • 陳俊延 Division of Cardiovascular Diseases
  • 林書毅 Division of Cardiovascular Diseases
  • 洪崇烈 Division of Cardiovascular Diseases
  • 劉俊傑 Division of Cardiovascular Diseases
  • 程崇偉 Division of Cardiovascular Diseases
  • 陳律安 Division of Cardiovascular Diseases
  • 郭任遠 Division of Cardiovascular Diseases
  • 李應湘 Division of Cardiovascular Diseases
  • 廖峰慶 Division of Cardiovascular Diseases
  • 林肇鋒 Division of Cardiovascular Diseases
  • 蘇正煌 Division of Cardiovascular Diseases
  • 李俊偉 Division of Cardiovascular Diseases
  • 簡禎彥 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Min-Ji Charng Division of Cardiovascular Diseases

Co-Principal Investigator

  • 陳隆景 Division of Cardiovascular Diseases
  • 蔡適吉 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方志元 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 張韶政 Division of Cardiovascular Diseases
  • 劉文浩 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王志鴻 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 張懷仁 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases

Co-Principal Investigator

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

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 詹貴川 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李貽恆 Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Chih Wang Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Completed

Condition/Disease

Atherosclerotic Cardiovascular Disease

Objectives

This trial was conducted to better understand the use of olpasiran (AMG 890) in patients with cardiovascular disease and elevated Lp(a). The trial will explore whether olpasiran (AMG 890) reduces cardiovascular events, lowers Lp(a), and causes any side effects.

Test Drug

olpasiran (AMG 890)

Active Ingredient

olpasiran (AMG 890)

Dosage Form

Preservative free solution for injection

Dosage

142 mg/mL

Endpoints

Time to CHD death, myocardial infarction, or emergency coronary revascularization, whichever occurs first

Inclution Criteria

Inclusion Criteria:

Age 18 to ≤ 85 years
Lp(a)≥ 200 nmol/L during screening
History of ASCVD as evidenced by history of either:

Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or
Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.

Exclusion Criteria

Exclusion Criteria:

Severe renal dysfunction
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening
History of hemorrhagic stroke
History of major bleeding disorder
Planned cardiac surgery or arterial revascularization
Severe heart failure
Current, recent, or planned lipoprotein apheresis
Previously received ribonucleic acid therapy specifically targeting Lp(a)

The Estimated Number of Participants

  • Taiwan

    75 participants

  • Global

    6000 participants