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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04023552




Registration number
NCT04023552
Ethics application status
Date submitted
16/07/2019
Date registered
17/07/2019

Titles & IDs
Public title
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Scientific title
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease
Secondary ID [1] 0 0
CTQJ230A12301
Secondary ID [2] 0 0
CTQJ230A12301
Universal Trial Number (UTN)
Trial acronym
Lp(a)HORIZON
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
Treatment: Drugs - TQJ230
Treatment: Drugs - Placebo

Experimental: TQJ230 - TQJ230 80 mg injected monthly administered subcutaneously

Placebo comparator: Placebo - Monthly subcutaneous injections.


Treatment: Drugs: TQJ230
TQJ230 80 mg injected monthly administered subcutaneously

Treatment: Drugs: Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) = 70 mg/dL
Timepoint [1] 0 0
approximately 4 years
Primary outcome [2] 0 0
Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) = 90 mg/dL.
Timepoint [2] 0 0
approximately 4 years
Secondary outcome [1] 0 0
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)
Timepoint [1] 0 0
approximately 4 years
Secondary outcome [2] 0 0
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization
Timepoint [2] 0 0
approximately 4 years
Secondary outcome [3] 0 0
Time to Clinical endpoint Committee confirmed all-cause death
Timepoint [3] 0 0
approximately 4 years
Secondary outcome [4] 0 0
Change in Lp(a) in the log scale from baseline
Timepoint [4] 0 0
Baseline, year 1

Eligibility
Key inclusion criteria
Key Inclusion Criteria

* Lp(a) = 70 mg/dL at the screening visit, measured at the Central laboratory
* Myocardial infarction: = 3 months from screening and randomization to = 10 years prior to the screening visit
* Ischemic stroke: = 3 months from screening and randomization to = 10 years prior to the screening visit
* Clinically significant symptomatic peripheral artery disease

Key
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count =LLN
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.

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
12/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
Accrual to date
Final
8323
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
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Novartis Investigative Site - Chemside
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Novartis Investigative Site - Southport
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Novartis Investigative Site - Woolloongabba
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Novartis Investigative Site - Clayton
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Novartis Investigative Site - Perth
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2050 - Camperdown
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2170 - Liverpool
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4032 - Chemside
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4215 - Southport
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4102 - Woolloongabba
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3168 - Clayton
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6000 - Perth
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Glasgow
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Harrow
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Leicester
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London
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Newcastle upon Tyne
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Newport
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Norwich
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Plymouth
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Sheffield
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Wrexham

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)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient -level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04023552