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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05581303




Registration number
NCT05581303
Ethics application status
Date submitted
12/10/2022
Date registered
14/10/2022
Date last updated
4/04/2024

Titles & IDs
Public title
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
Secondary ID [1] 0 0
20180244
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Olpasiran

Placebo comparator: Placebo - Placebo will be administered by subcutaneous injection

Experimental: Olpasiran - Olpasiran will be administered by subcutaneous injection


Treatment: Drugs: Placebo
Placebo given by subcutaneous injection once every 12 weeks (Q12W).

Treatment: Drugs: Olpasiran
Olpasiran given by subcutaneous injection Q12W.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [1] 0 0
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [2] 0 0
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
Timepoint [2] 0 0
Approximately 4 years
Secondary outcome [3] 0 0
Percent change from baseline to Week 48 in Lipoprotein(a)
Timepoint [3] 0 0
Baseline and Week 48
Secondary outcome [4] 0 0
Time to myocardial infarction
Timepoint [4] 0 0
Approximately 4 years
Secondary outcome [5] 0 0
Time to CHD death or myocardial infarction, whichever occurs first
Timepoint [5] 0 0
Approximately 4 years
Secondary outcome [6] 0 0
Time to urgent coronary revascularization
Timepoint [6] 0 0
Approximately 4 years
Secondary outcome [7] 0 0
Time to coronary revascularization
Timepoint [7] 0 0
Approximately 4 years
Secondary outcome [8] 0 0
Time to CHD death
Timepoint [8] 0 0
Approximately 4 years
Secondary outcome [9] 0 0
Time to cardiovascular death
Timepoint [9] 0 0
Approximately 4 years
Secondary outcome [10] 0 0
Time to death by any cause
Timepoint [10] 0 0
Approximately 4 years
Secondary outcome [11] 0 0
Time to ischemic stroke
Timepoint [11] 0 0
Approximately 4 years

Eligibility
Key inclusion criteria
* Age 18 to = 85 years
* Lp(a)= 200 nmol/L during screening
* 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2026
Actual
Sample size
Target
Accrual to date
Final
7297
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Liverpool Hospital - Liverpool
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Holdsworth House Medical Practice - Sydney
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Wollongong Hospital - Wollongong
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Advara HeartCare Wesley - Auchenflower
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Advara HeartCare Bundaberg - Bundaberg
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Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [10] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [11] 0 0
Dr Heart Pty Ltd - Woolloongabba
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Nightingale Research - Adelaide
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Flinders Medical Centre - Bedford Park
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Advara HeartCare Leabrook - Leabrook
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Royal Hobart Hospital - Hobart
Recruitment hospital [16] 0 0
Advara HeartCare Berwick - Berwick
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Victorian Heart Hospital - Clayton
Recruitment hospital [18] 0 0
The Cardiologists Proprietary Limited - Epping
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Barwon Health Geelong Hospital - Geelong
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Advara HeartCare Ringwood - Ringwood
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Advara HeartCare Joondalup - Joondalup
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Mount Hospital - Murdoch
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Linear Clinical Research Limited - Nedlands
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2605 - Garran
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2050 - Camperdown
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2139 - Concord
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2170 - Liverpool
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2010 - Sydney
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2500 - Wollongong
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4066 - Auchenflower
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4670 - Bundaberg
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4029 - Herston
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4064 - Milton
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4102 - Woolloongabba
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5000 - Adelaide
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5042 - Bedford Park
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5068 - Leabrook
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7000 - Hobart
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3806 - Berwick
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3168 - Clayton
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6027 - Joondalup
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6009 - Nedlands
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Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
Trial website
https://clinicaltrials.gov/study/NCT05581303
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05581303