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

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

Sponsors and collaborators