OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olpasiran, Placebo.
- Who it may be relevant to
- Registry conditions: Cardiovascular Disease. Basic parameters: 50 years — 105 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
Overview
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).
Interventions
- Drug Olpasiran
Olpasiran will be administered via SC injection. - Drug Placebo
Placebo will be administered via SC injection.
Primary outcome measures
- Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First [Time frame: Up to approximately 6.2 years]
Secondary outcome measures (12)
- Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First [Time frame: Up to approximately 6.2 years]
- Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First [Time frame: Up to approximately 6.2 years]
- Percent Change From Baseline to Week 48 Lp(a) Levels [Time frame: Baseline and Week 48]
- Time to Myocardial Infarction [Time frame: Up to approximately 6.2 years]
- Time to CHD Death or Myocardial Infarction, Whichever Occurs First [Time frame: Up to approximately 6.2 years]
- Time to Urgent Coronary Revascularization [Time frame: Up to approximately 6.2 years]
- Time to Coronary Revascularization [Time frame: Up to approximately 6.2 years]
- Time to CHD Death [Time frame: Up to approximately 6.2 years]
- Time to Cardiovascular Death [Time frame: Up to approximately 6.2 years]
- Time to Death by any Cause [Time frame: Up to approximately 6.2 years]
- Time to Ischemic Stroke [Time frame: Up to approximately 6.2 years]
- Serum Concentration of Olpasiran [Time frame: Up to Week 48]
Eligibility criteria
Inclusion criteria
- Age ≥50 years
- Lp(a)≥ 200 nmol/L during screening
- Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
Exclusion criteria
- Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
- Prior or planned arterial revascularization
- History of major bleeding disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 205 centers
- Advanced Cardiovascular LLC — Alexander City
- University of Alabama Birmingham Saint Vincents Birmingham — Birmingham
- Birmingham Clinical Research — Birmingham
- Alliance For Multispecialty Research - Daphne — Daphne
- Eastern Shore Research Institute — Fairhope
- Heart Center Research LLC — Huntsville
- CB Flock Research Corporation — Mobile
- Phoenix Clinical — Phoenix
- … and 197 more centers
Canada · 24 centers
Center list to be confirmed — check the primary protocol.
Australia · 22 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07136012 · 20230222