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. 2024 Mar 29;18:100641. doi: 10.1016/j.ajpc.2024.100641

Table 2.

Comparison between ongoing phase 3 cardiovascular outcomes trials.

HORIZON (Pelacarsen) OCEAN(a)-Outcomes (Olpasiran)
Sponsor (Phase) Novartis (P3) Amgen (P3)
Study Design Randomized double-blind, placebo-controlled, multicenter trial Randomized double-blind, placebo-controlled, multicenter trial
Population Age 18 to 80 years
N = 7680
Age 18 to 85 years
N∼6000
Mechanism Antisense oligonucleotides (ASO) Small interfering RNA (siRNA)
Intervention SC injection Q4 weeks SC injection Q12 weeks
Key Inclusion Criteria Lp(a) ≥ 70 mg/dLCVD, as evidence by either:
  • MI (≥ 3 months to ≤ 10 yrs)

  • Ischemic stroke (≥ 3 months to ≤ 10 yrs)

  • Symptomatic PAD

Lp(a) > 200 nmol/LASCVD, as evidence by either:
  • MI

  • Coronary Revascularization with PCI + 1 additional risk factor

Primary Endpoint Cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary revascularization requiring hospitalization (∼4.25 years) CHD death, MI, urgent coronary revascularization
Status Enrollment completed Enrollment ongoing

P3=phase 3, SC=subcutaneous, CVD=cardiovascular disease, MI=myocardial infarction, PAD=peripheral arterial disease, PCI=percutaneous coronary intervention.