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OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

ConditionCardiovascular Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-105
SponsorAmgen

About this trial

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\[a\]).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥50 years

Lp(a)≥ 200 nmol/L during screening

Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

Disqualifiers

Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)

Prior or planned arterial revascularization

History of major bleeding disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olpasiran

    Drug

    Olpasiran will be administered via SC injection.

  • Placebo

    Drug

    Placebo will be administered via SC injection.

Treatment groups

11,000 Participants
are divided into 2 treatment groups
Group A: OlpasiranExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First

Time frame
Up to approximately 6.2 years

Secondary outcomes

1

Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First

Time frame
Up to approximately 6.2 years
2

Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First

Time frame
Up to approximately 6.2 years
3

Percent Change From Baseline to Week 48 Lp(a) Levels

Time frame
Baseline and Week 48
4

Time to Myocardial Infarction

Time frame
Up to approximately 6.2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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