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

Amgen

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Olpasiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT07293260

20230191

Details and patient eligibility

About

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).

Enrollment: 406 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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406 participants in 2 patient groups, including a placebo group

Olpasiran

Experimental group

Description:

Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).

Treatment:

Drug: Olpasiran

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC Q12W.

Treatment:

Drug: Placebo