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

Phase 3

Active, not recruiting

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Drug: Placebo; Drug: Olpasiran

• Registration Number: NCT05581303
• Lead Sponsor: Amgen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Study Start: 2022-12-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-12-29
• Study Completion: 2026-12-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7297

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be administered by subcutaneous injection
Olpasiran	Olpasiran	Olpasiran will be administered by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first	Approximately 4 years

Secondary Outcome Measures

Name	Time	Method
Time to coronary revascularization	Approximately 4 years
Time to death by any cause	Approximately 4 years
Time to ischemic stroke	Approximately 4 years
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first	Approximately 4 years
Percent change from baseline to Week 48 in Lipoprotein(a)	Baseline and Week 48
Time to cardiovascular death	Approximately 4 years
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first	Approximately 4 years
Time to myocardial infarction	Approximately 4 years
Time to CHD death or myocardial infarction, whichever occurs first	Approximately 4 years
Time to urgent coronary revascularization	Approximately 4 years
Time to CHD death	Approximately 4 years

Trial Locations

Locations (728)

NSC Research; 🇺🇸 Johns Creek, Georgia, United States

Instituto de Investigaciones Clinicas Quilmes; 🇦🇷 Quilmes, Buenos Aires, Argentina

University of Hong Kong, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Tohoku University Hospital; 🇯🇵 Sendai-shi, Miyagi, Japan

Sakurabashi Watanabe Advanced Healthcare Hospital; 🇯🇵 Osaka-shi, Osaka, Japan

Unidade de Saude Local de Almada-Seixal, EPE - Hospital Garcia de Orta; 🇵🇹 Almada, Portugal

Unidade Local de Saude de Amadora-Sintra, EPE; 🇵🇹 Amadora, Portugal

Unidade Local de Saude da Regiao de Aveiro, EPE - Hospital Infante Dom Pedro; 🇵🇹 Aveiro, Portugal

Unidade Local de Saude de Braga, EPE; 🇵🇹 Braga, Portugal

Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal

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