Recruiting
Sponsor ID
20230222

OCEAN(a)-PreEvent - Olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction to Prevent first major cardiovascular Events

Sponsor ID
20230222
Clinicaltrials.gov ID
NCT07136012
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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]).

Additional Study Details

Phase
Phase 3
Product
Olpasiran
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
11000
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Up to approximately 6.2 years

Secondary Outcome Measures

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

Timeframe: Up to approximately 6.2 years

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

Timeframe: Up to approximately 6.2 years

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

Timeframe: Baseline and Week 48

Time to Myocardial Infarction

Timeframe: Up to approximately 6.2 years

Time to CHD Death or Myocardial Infarction, Whichever Occurs First

Timeframe: Up to approximately 6.2 years

Time to Urgent Coronary Revascularization

Timeframe: Up to approximately 6.2 years

Time to Coronary Revascularization

Timeframe: Up to approximately 6.2 years

Time to CHD Death

Timeframe: Up to approximately 6.2 years

Time to Cardiovascular Death

Timeframe: Up to approximately 6.2 years

Time to Death by any Cause

Timeframe: Up to approximately 6.2 years

Time to Ischemic Stroke

Timeframe: Up to approximately 6.2 years

Serum Concentration of Olpasiran

Timeframe: Up to Week 48

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 6.2 years

Locations

Location
Status
Contact Us
Location
Advara HeartCare Leabrook
Leabrook, SA, Australia, 5068
Status
Recruiting
Location
Advara HeartCare Joondalup
Joondalup, WA, Australia, 6027
Status
Recruiting
Location
Advara HeartCare Wesley
Auchenflower, QLD, Australia, 4066
Status
Recruiting
Location
North York Diagnostic and Cardiac Centre
North York, ON, Canada, M6B 3H7
Status
Recruiting
Location
Heart Center Research LLC
Huntsville, AL, United States, 35801
Status
Recruiting
Location
Carient Heart and Vascular
Manassas, VA, United States, 20109
Status
Recruiting
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