臨床研究等提出・公開システム

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

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

Matsumoto Hiroki

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

clinicaltrials_japan@amgen.com

Local Contact

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

+81-80-7217-8592

clinicaltrials_japan@amgen.com

Not Recruiting

Dec. 14, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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)

Both

Atherosclerotic Cardiovascular Disease

- 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

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

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 ]

Nov. 10, 2022

Yes

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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