Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

Amgen

Status and phase: Active, not recruiting; Phase 3

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Drug: Placebo; Drug: Olpasiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT05581303

20180244

Details and patient eligibility

About

The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

Enrollment: 7,297 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

• 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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7,297 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo will be administered by subcutaneous injection

Treatment:

Drug: Placebo

Olpasiran

Experimental group

Description:

Olpasiran will be administered by subcutaneous injection

Treatment:

Drug: Olpasiran