The trial is taking place at:
N

Nucleo de Pesquisa Clinica | Curitiba, Brazil

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

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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

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

Trial contacts and locations

737

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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