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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/NCT03887520




Registration number
NCT03887520
Ethics application status
Date submitted
21/03/2019
Date registered
25/03/2019
Date last updated
28/01/2022

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
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
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
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
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
Recruitment postcode(s) [1] 0 0
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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Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in
patients with established cardiovascular disease (CVD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03887520
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03887520