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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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Recruitment hospital [3] 0 0
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
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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
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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
Recruitment hospital [23] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
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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6027 - Joondalup
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6150 - Murdoch
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6009 - Nedlands
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Germany
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Witten
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Mitilini
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Greece
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin, New Territories
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Hungary
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Baja
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Hungary
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Hatvan
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Hungary
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Komarom
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Hungary
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Miskolc
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Oroshaza
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Hungary
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Hungary
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Brescia
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Caserta
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Italy
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Catania
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Italy
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Catanzaro
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Italy
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Cona FE
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Italy
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Firenze
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Rivoli
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Italy
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Roma
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Italy
State/province [236] 0 0
Rozzano MI
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Italy
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Salerno
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Italy
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Sesto San Giovanni (MI)
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Italy
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Torino
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Japan
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Aichi
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Japan
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Japan
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Chiba
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Japan
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Fukui
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Iwate
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Japan
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Kagawa
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Japan
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Kagoshima
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Japan
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Japan
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Kochi
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Japan
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Kumamoto
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Japan
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Japan
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Miyazaki
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Japan
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Japan
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Saga
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Japan
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Saitama
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Japan
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Japan
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Yamaguchi
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Japan
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Yamanashi
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Korea, Republic of
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Korea, Republic of
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Alytus
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
Country [280] 0 0
Lithuania
State/province [280] 0 0
Siauliai
Country [281] 0 0
Lithuania
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Vilnius
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Mexico
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Jalisco
Country [283] 0 0
Mexico
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Nuevo León
Country [284] 0 0
Mexico
State/province [284] 0 0
Sinaloa
Country [285] 0 0
Mexico
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Veracruz
Country [286] 0 0
Mexico
State/province [286] 0 0
Aguascalientes
Country [287] 0 0
Mexico
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Chihuahua
Country [288] 0 0
Mexico
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Ciudad de México
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Arnhem
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Bergen op Zoom
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Breda
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Delft
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Netherlands
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Den Haag
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Netherlands
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Deventer
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Netherlands
State/province [298] 0 0
Eindhoven
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Netherlands
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Enschede
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Netherlands
State/province [300] 0 0
Goes
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Netherlands
State/province [301] 0 0
Gouda
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Netherlands
State/province [302] 0 0
Groningen
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Netherlands
State/province [303] 0 0
Heerlen
Country [304] 0 0
Netherlands
State/province [304] 0 0
Hoofddorp
Country [305] 0 0
Netherlands
State/province [305] 0 0
Hoorn
Country [306] 0 0
Netherlands
State/province [306] 0 0
Leiden
Country [307] 0 0
Netherlands
State/province [307] 0 0
Leiderdorp
Country [308] 0 0
Netherlands
State/province [308] 0 0
Nijmegen
Country [309] 0 0
Netherlands
State/province [309] 0 0
Rotterdam
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Netherlands
State/province [310] 0 0
Sneek
Country [311] 0 0
Netherlands
State/province [311] 0 0
The Hague
Country [312] 0 0
Netherlands
State/province [312] 0 0
Tiel
Country [313] 0 0
Netherlands
State/province [313] 0 0
Tilburg
Country [314] 0 0
Netherlands
State/province [314] 0 0
Utrecht
Country [315] 0 0
Netherlands
State/province [315] 0 0
Venlo
Country [316] 0 0
Norway
State/province [316] 0 0
Oslo
Country [317] 0 0
Norway
State/province [317] 0 0
Skedsmokorset
Country [318] 0 0
Poland
State/province [318] 0 0
Belchatow
Country [319] 0 0
Poland
State/province [319] 0 0
Bielsko-Biala
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Poland
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Chrzanow
Country [321] 0 0
Poland
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Dabrowa Gornicza
Country [322] 0 0
Poland
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Gdansk
Country [323] 0 0
Poland
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Gizycko
Country [324] 0 0
Poland
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Kedzierzyn Kozle
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Poland
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Krakow
Country [326] 0 0
Poland
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Lodz
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Poland
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Lubin
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Poland
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Poland
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Portugal
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Braga
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Portugal
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Carnaxide
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Portugal
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Cascais
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Portugal
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Coimbra
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Portugal
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Portugal
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Matosinhos
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Santa Maria da Feira
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Portugal
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Portugal
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Romania
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Romania
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Romania
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Slovakia
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Slovakia
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Kosice
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Slovakia
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Lucenec
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Slovakia
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Moldava nad Bodvou
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Slovakia
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Namestovo
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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Slovakia
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Presov
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Slovakia
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Slovakia
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Slovakia
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Svidnik
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Slovakia
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Slovakia
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Trencin
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Spain
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Spain
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Aragón
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Spain
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Spain
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Spain
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Cataluña
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Murcia
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Spain
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Madrid
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Falun
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Sweden
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Sweden
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Helsingborg
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Lund
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Malmo
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Hualien
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
Country [397] 0 0
United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Blackpool
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United Kingdom
State/province [400] 0 0
Bradford
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United Kingdom
State/province [401] 0 0
Bristol
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United Kingdom
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Chichester
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United Kingdom
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Chippenham
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United Kingdom
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Craigavon
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United Kingdom
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Enfield
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United Kingdom
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Exeter
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United Kingdom
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Glasgow
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United Kingdom
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Harefield
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United Kingdom
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High Wycombe
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United Kingdom
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Inverness
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United Kingdom
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Leicester
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United Kingdom
State/province [412] 0 0
Lincoln
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United Kingdom
State/province [413] 0 0
London
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United Kingdom
State/province [414] 0 0
Penarth
Country [415] 0 0
United Kingdom
State/province [415] 0 0
Poole
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United Kingdom
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Preston
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United Kingdom
State/province [417] 0 0
Stevenage

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.