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Recruiting
Sponsor ID
20230191

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography TrialOCEAN(a)-CCTA

Sponsor ID
20230191
Clinicaltrials.gov ID
NCT07293260
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).

Additional Study Details

Phase
Phase 3
Product
Olpasiran
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
406
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in NCP Volume from Baseline to Week 72

Timeframe: Baseline to Week 72

Secondary Outcome Measures

Change in Low Attenuation Plaque Volume from Baseline to Week 72

Timeframe: Baseline to Week 72

Change in Total Plaque Volume from Baseline to Week 72

Timeframe: Baseline to Week 72

Change in Calcified Plaque Volume from Baseline to Week 72

Timeframe: Baseline to Week 72

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Week 74

Locations

Location
Status
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Location
University of The Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, QLD, Australia, 4556
Status
Recruiting
Location
North York Diagnostic and Cardiac Centre
Vaughan, ON, Canada, L6A 4N9
Status
Recruiting
Location
Peking University First Hospital
Beijing, Beijing, China, 100034
Status
Recruiting
Location
Jinan Central Hospital
Jinan, Shandong, China, 250013
Status
Recruiting
Location
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Status
Recruiting
Location
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Status
Recruiting
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Study Info
Age
35 - 80 Years
Condition
  • Cardiovascular Disease
    • Sex
    All
    Trial Dates
    Mar 2026 - Jun 2028
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Age 35 to ≤ 80 years. • Lp(a) ≥ 200 nmol/L during screening. • Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. • History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.
    Exclusion Criteria:
    • History of coronary artery bypass graft (CABG). • Moderate to 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).