Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
- Conditions
- Atherosclerotic Cardiovascular Disease
- Registration Number
- JPRN-jRCT2031220596
- Lead Sponsor
- Asato Keita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6000
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method