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

JRCT ID: jRCT2031220596

Registered date:31/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atherosclerotic Cardiovascular Disease
• Date of first enrollment: 14/12/2022
• Target sample size: 7000
• Countries of recruitment: Australia,Japan,Canada,Japan,United States,Japan,Argentina,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,China,Japan,Czechia,Japan,Denmark,Japan,Estonia,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,Iceland,Japan,Italy,Japan,Lithuania,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,United Kingdom,Japan,Korea,Japan
• Study type: Interventional

Intervention(s)

- Placebo Comparator: Placebo
Placebo will be administered by subcutaneous injection.
Intervention: Drug: Placebo

- Experimental: Olpasiran
Olpasiran will be administered by subcutaneous injection.
Intervention: Drug: Olpasiran

Outcome(s)

• Primary Outcome: 1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first [ Time Frame: Approximately 4 years ]

Secondary Outcome

1. Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first [ Time Frame: Approximately 4 years ]
2. Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first [ Time Frame: Approximately 4 years ]
3. Percent change from baseline to Week 48 in Lipoprotein(a) [ Time Frame: Baseline and Week 48 ]
4. Time to myocardial infarction [ Time Frame: Approximately 4 years ]
5. Time to CHD death or myocardial infarction, whichever occurs first [ Time Frame: Approximately 4 years ]
6. Time to urgent coronary revascularization [ Time Frame: Approximately 4 years ]
7. Time to coronary revascularization [ Time Frame: Approximately 4 years ]
8. Time to CHD death [ Time Frame: Approximately 4 years ]
9. Time to cardiovascular death [ Time Frame: Approximately 4 years ]
10. Time to death by any cause [ Time Frame: Approximately 4 years ]
11. Time to ischemic stroke [ Time Frame: Approximately 4 years ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Age 18 to <= 85 years
2. Lp(a) >= 200 nmol/L during screening
3. 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.

Exclude criteria

1. Severe renal dysfunction
2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening.
3. History of hemorrhagic stroke
4. History of major bleeding disorder
5. Planned cardiac surgery or arterial revascularization
6. Severe heart failure
7. Current, recent, or planned lipoprotein apheresis
8. Previously received ribonucleic acid therapy specifically targeting Lp(a)

Related Information

• Primary Sponsor: Asato Keita
• Secondary ID(s): NCT05581303