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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05378529




Registration number
NCT05378529
Ethics application status
Date submitted
2/05/2022
Date registered
18/05/2022
Date last updated
18/01/2024

Titles & IDs
Public title
A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)
Scientific title
A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease
Secondary ID [1] 0 0
20210057
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
Other interventions - Lp(a) Screening

Other: Participants with history of ASCVD - Participants with history of ASCVD with known or unknown Lp(a) values.


Other interventions: Lp(a) Screening
Participants will provide demographic information and have a blood draw for Lp(a) levels if they are unknown.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with elevated Lp(a) with documented history of ASCVD
Timepoint [1] 0 0
Up to approximately 2 weeks
Secondary outcome [1] 0 0
Lp(a) Levels
Timepoint [1] 0 0
Up to approximately 2 weeks
Secondary outcome [2] 0 0
Lp(a) Levels stratified by demographics and region
Timepoint [2] 0 0
Up to approximately 2 weeks

Eligibility
Key inclusion criteria
- Signed informed consent

- History of ASCVD
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants known to be currently receiving investigational drug in a clinical study

- Participants with a diagnosis of end-stage renal disease or requiring dialysis

- Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months
prior to enrollment

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2023
Sample size
Target
Accrual to date
Final
39480
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
Recruitment hospital [8] 0 0
Advara HeartCare Bundaberg - Bundaberg
Recruitment hospital [9] 0 0
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
Recruitment hospital [13] 0 0
SA Heart - Ashford
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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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Advara HeartCare Ringwood - Bundoora
Recruitment hospital [18] 0 0
The Cardiologists Proprietary Limited - Epping
Recruitment hospital [19] 0 0
Barwon Health Geelong Hospital - Geelong
Recruitment hospital [20] 0 0
Advara HeartCare Joondalup - Joondalup
Recruitment hospital [21] 0 0
Clinitrials - 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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5035 - Ashford
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5068 - Leabrook
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7000 - Hobart
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3806 - Berwick
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3083 - Bundoora
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3076 - Epping
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3220 - Geelong
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6027 - Joondalup
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6009 - Nedlands
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Worcester

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a))
levels among participants with a history of ASCVD as defined by their medical history and is
2-fold:

- Evaluate the distribution of Lp(a) value in the overall participants with documented
history of ASCVD

- Evaluate the distribution of Lp(a) value in participants with documented history of
ASCVD by demographics and regions
Trial website
https://clinicaltrials.gov/ct2/show/NCT05378529
Trial related presentations / publications
Public notes

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