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Recruiting NCT07293260

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial

Phase III Interventional Cardiovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Olpasiran, Placebo.
Who it may be relevant to
Registry conditions: Cardiovascular Disease. Basic parameters: 35 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, China, Denmark +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

Overview

The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).

Interventions

  • Drug Olpasiran
    Olpasiran will be administered SC.
  • Drug Placebo
    Placebo will be administered SC.

Primary outcome measures

  • Change in NCP Volume from Baseline to Week 72 [Time frame: Baseline to Week 72]
Secondary outcome measures (4)
  • Change in Low Attenuation Plaque Volume from Baseline to Week 72 [Time frame: Baseline to Week 72]
  • Change in Total Plaque Volume from Baseline to Week 72 [Time frame: Baseline to Week 72]
  • Change in Calcified Plaque Volume from Baseline to Week 72 [Time frame: Baseline to Week 72]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to Week 74]

Eligibility criteria

Inclusion criteria

  • Age 35 to ≤ 80 years.
  • Lp(a) ≥ 200 nmol/L during screening.
  • Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.
  • History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.

Exclusion criteria

  • History of coronary artery bypass graft (CABG).
  • Moderate to 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 8 centers
  • Peking University First Hospital — Beijing
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • The Second Xiangya Hospital of Central South University — Changsha
  • The Third Xiangya Hospital of Central South University — Changsha
  • The Second Affiliated Hospital of Nanjing Medical University — Nanjing
  • General Hospital of Ningxia Medical University — Yinchuan
  • Shaanxi Provincial Peoples Hospital — Xi'an
  • Jinan Central Hospital — Jinan
United States · 6 centers
  • Bridgeport Hospital — Bridgeport
  • Jacksonville Center for Clinical Research — Jacksonville
  • Midwest Heart and Vascular Specialists — Overland Park
  • Flourish Bowie — Bowie
  • Montefiore Medical Center - Bronx — Philadelphia
  • Vital Heart and Vein — Humble
France · 4 centers
  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur — Nice
  • Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque — Pessac
  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil — Toulouse
  • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau — Tours
Germany · 4 centers
  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin — Berlin
  • Universitaetsklinikum Essen — Essen
  • Universitaetsklinikum Frankfurt — Frankfurt am Main
  • Klinikum rechts der Isar der TUM — München
Italy · 4 centers
  • Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna — Ferrara
  • IRCCS Centro Cardiologico Monzino — Milan
  • IRCCS Policlinico San Donato — San Donato Milanese
  • Azienda Ospedaliera Ordine Mauriziano di Torino — Torino
Spain · 4 centers
  • Hospital Universitario Virgen Macarena — Seville
  • Hospital Alvaro Cunqueiro — Vigo
  • Hospital Universitari i Politecnic La Fe — Valencia
  • Hospital Universitario Ramon y Cajal — Madrid
Australia · 3 centers
  • Advara HeartCare Wesley — Auchenflower
  • University of The Sunshine Coast Clinical Trials, Sippy Downs — Sippy Downs
  • Advara HeartCare Leabrook — Leabrook
Japan · 3 centers
  • Tomakomai City Hospital — Tomakomai-shi
  • Osaka Keisatsu Hospital — Osaka
  • University of Yamanashi Hospital — Chuo-shi
Denmark · 2 centers
  • Regionshospitalet Gødstrup — Herning
  • Regionshospitalet Viborg — Viborg
Canada · 1 center
  • North York Diagnostic and Cardiac Centre — Vaughan
Netherlands · 1 center
  • Tergooiziekenhuizen, locatie Hilversum — Hilversum

Identifiers

NCT: NCT07293260 · 20230191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗