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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03887520




Registration number
NCT03887520
Ethics application status
Date submitted
21/03/2019
Date registered
25/03/2019

Titles & IDs
Public title
Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)
Scientific title
Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease
Secondary ID [1] 0 0
2018-003786-34
Secondary ID [2] 0 0
CTQJ230A12001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease and Lipoprotein(a) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Blood draw for Lp(a)

Other: Cardiovascular disease - Patients with established Cardiovascular disease


Diagnosis / Prognosis: Blood draw for Lp(a)
Collect sample for Lipoprotein(a) testing
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD)
Timepoint [1] 0 0
At screening
Secondary outcome [1] 0 0
Lipoprotein(a) (Lp(a)) values
Timepoint [1] 0 0
At screening
Secondary outcome [2] 0 0
Lp(a) values by region and country
Timepoint [2] 0 0
At screening
Secondary outcome [3] 0 0
Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected)
Timepoint [3] 0 0
At screening

Eligibility
Key inclusion criteria
* Signed informed consent
* Established CVD defined as one of the following:

* History of a myocardial infarction (MI) =3 months and =10 years before the study visit
* History of ischemic stroke = 3 months and = 10 years before the study visit
* Symptomatic PAD (intermitted claudication with ankle-brachial index =0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients currently enrolled in clinical studies with investigational drugs

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
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
NA
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
27/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2021
Sample size
Target
Accrual to date
Final
49001
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
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Novartis Investigative Site - Liverpool
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Novartis Investigative Site - Chemside
Recruitment hospital [4] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [5] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [6] 0 0
Novartis Investigative Site - Perth
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2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4032 - Chemside
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
6000 - Perth
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Southampton
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Tyne And Wear
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Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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)?
No
No/undecided IPD sharing reason/comment


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.


Results not provided in https://clinicaltrials.gov/study/NCT03887520