Health Trials

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

ConditionCardiovascular Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age35-80
SponsorAmgen

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Olpasiran
  • Placebo

Treatment groups

406 Participants
are divided into 2 treatment groups

Locations

40
Australia
Advara HeartCare Wesley4066, AuchenflowerQueensland, Australia
University of The Sunshine Coast Clinical Trials, Sippy Downs4556, Sippy DownsQueensland, Australia
Advara HeartCare Leabrook5068, LeabrookSouth Australia, Australia
Canada
North York Diagnostic and Cardiac CentreL6A 4N9, VaughanOntario, Canada

Sponsors and collaborators

Amgen

Lead sponsor

Source ClinicalTrials.gov