Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04023552




Registration number
NCT04023552
Ethics application status
Date submitted
16/07/2019
Date registered
17/07/2019
Date last updated
16/05/2024

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
Recruitment hospital [3] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [4] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [6] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [7] 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
4215 - Southport
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
New Hampshire
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
West Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Wisconsin
Country [39] 0 0
Argentina
State/province [39] 0 0
Buenos Aires
Country [40] 0 0
Argentina
State/province [40] 0 0
San Miguel De Tucuman
Country [41] 0 0
Argentina
State/province [41] 0 0
Santa Fe
Country [42] 0 0
Argentina
State/province [42] 0 0
Tucuman
Country [43] 0 0
Argentina
State/province [43] 0 0
Caba
Country [44] 0 0
Argentina
State/province [44] 0 0
Capital Federal
Country [45] 0 0
Argentina
State/province [45] 0 0
Cordoba
Country [46] 0 0
Argentina
State/province [46] 0 0
Corrientes
Country [47] 0 0
Argentina
State/province [47] 0 0
San Luis
Country [48] 0 0
Austria
State/province [48] 0 0
Graz
Country [49] 0 0
Austria
State/province [49] 0 0
Innsbruck
Country [50] 0 0
Austria
State/province [50] 0 0
Linz
Country [51] 0 0
Austria
State/province [51] 0 0
Salzburg
Country [52] 0 0
Austria
State/province [52] 0 0
Wien
Country [53] 0 0
Belgium
State/province [53] 0 0
Aalst
Country [54] 0 0
Belgium
State/province [54] 0 0
Brugge
Country [55] 0 0
Belgium
State/province [55] 0 0
Bruxelles
Country [56] 0 0
Belgium
State/province [56] 0 0
Dendermonde
Country [57] 0 0
Belgium
State/province [57] 0 0
Genk
Country [58] 0 0
Belgium
State/province [58] 0 0
Huy
Country [59] 0 0
Belgium
State/province [59] 0 0
Kortrijk
Country [60] 0 0
Belgium
State/province [60] 0 0
Mechelen
Country [61] 0 0
Brazil
State/province [61] 0 0
AL
Country [62] 0 0
Brazil
State/province [62] 0 0
BA
Country [63] 0 0
Brazil
State/province [63] 0 0
DF
Country [64] 0 0
Brazil
State/province [64] 0 0
ES
Country [65] 0 0
Brazil
State/province [65] 0 0
GO
Country [66] 0 0
Brazil
State/province [66] 0 0
MG
Country [67] 0 0
Brazil
State/province [67] 0 0
Minas Gerais
Country [68] 0 0
Brazil
State/province [68] 0 0
Parana
Country [69] 0 0
Brazil
State/province [69] 0 0
PR
Country [70] 0 0
Brazil
State/province [70] 0 0
RS
Country [71] 0 0
Brazil
State/province [71] 0 0
Santa Catarina
Country [72] 0 0
Brazil
State/province [72] 0 0
SE
Country [73] 0 0
Brazil
State/province [73] 0 0
SP
Country [74] 0 0
Brazil
State/province [74] 0 0
Rio de Janeiro
Country [75] 0 0
Brazil
State/province [75] 0 0
Sao Paulo
Country [76] 0 0
Bulgaria
State/province [76] 0 0
Blagoevgrad
Country [77] 0 0
Bulgaria
State/province [77] 0 0
Burgas
Country [78] 0 0
Bulgaria
State/province [78] 0 0
Pernik
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Pleven
Country [80] 0 0
Bulgaria
State/province [80] 0 0
Plovdiv
Country [81] 0 0
Bulgaria
State/province [81] 0 0
Ruse
Country [82] 0 0
Bulgaria
State/province [82] 0 0
Sofia
Country [83] 0 0
Canada
State/province [83] 0 0
British Columbia
Country [84] 0 0
Canada
State/province [84] 0 0
Ontario
Country [85] 0 0
Canada
State/province [85] 0 0
Quebec
Country [86] 0 0
Chile
State/province [86] 0 0
Region Metropolitana
Country [87] 0 0
Chile
State/province [87] 0 0
RM
Country [88] 0 0
Chile
State/province [88] 0 0
Santiago
Country [89] 0 0
China
State/province [89] 0 0
Gansu
Country [90] 0 0
China
State/province [90] 0 0
Guangdong
Country [91] 0 0
China
State/province [91] 0 0
Heilongjiang
Country [92] 0 0
China
State/province [92] 0 0
Hubei
Country [93] 0 0
China
State/province [93] 0 0
Hunan
Country [94] 0 0
China
State/province [94] 0 0
Inner Mongolia
Country [95] 0 0
China
State/province [95] 0 0
Jiangsu
Country [96] 0 0
China
State/province [96] 0 0
Jilin
Country [97] 0 0
China
State/province [97] 0 0
Liaoning
Country [98] 0 0
China
State/province [98] 0 0
Shandong
Country [99] 0 0
China
State/province [99] 0 0
Shanxi
Country [100] 0 0
China
State/province [100] 0 0
Sichuan
Country [101] 0 0
China
State/province [101] 0 0
Tianjin
Country [102] 0 0
China
State/province [102] 0 0
Xinjiang
Country [103] 0 0
China
State/province [103] 0 0
Zhejiang
Country [104] 0 0
China
State/province [104] 0 0
Beijing
Country [105] 0 0
China
State/province [105] 0 0
Nanjing
Country [106] 0 0
China
State/province [106] 0 0
Shanghai
Country [107] 0 0
China
State/province [107] 0 0
Xiamen
Country [108] 0 0
Colombia
State/province [108] 0 0
Antioquia
Country [109] 0 0
Colombia
State/province [109] 0 0
Cundinamarca
Country [110] 0 0
Colombia
State/province [110] 0 0
Santander
Country [111] 0 0
Colombia
State/province [111] 0 0
Valle Del Cauca
Country [112] 0 0
Colombia
State/province [112] 0 0
Barranquilla
Country [113] 0 0
Colombia
State/province [113] 0 0
Bogota
Country [114] 0 0
Colombia
State/province [114] 0 0
Medellin
Country [115] 0 0
Colombia
State/province [115] 0 0
San Gil
Country [116] 0 0
Czechia
State/province [116] 0 0
Czech Republic
Country [117] 0 0
Czechia
State/province [117] 0 0
CZE
Country [118] 0 0
Czechia
State/province [118] 0 0
Brno Bohunice
Country [119] 0 0
Czechia
State/province [119] 0 0
Brno
Country [120] 0 0
Czechia
State/province [120] 0 0
Broumov
Country [121] 0 0
Czechia
State/province [121] 0 0
Chlumec nad Cidlinou
Country [122] 0 0
Czechia
State/province [122] 0 0
Hlucin
Country [123] 0 0
Czechia
State/province [123] 0 0
Hodonin
Country [124] 0 0
Czechia
State/province [124] 0 0
JIhlava
Country [125] 0 0
Czechia
State/province [125] 0 0
Kolin
Country [126] 0 0
Czechia
State/province [126] 0 0
Liberec
Country [127] 0 0
Czechia
State/province [127] 0 0
Marianske lazne
Country [128] 0 0
Czechia
State/province [128] 0 0
Melnik
Country [129] 0 0
Czechia
State/province [129] 0 0
Olomouc
Country [130] 0 0
Czechia
State/province [130] 0 0
Ostrava
Country [131] 0 0
Czechia
State/province [131] 0 0
Praha 5
Country [132] 0 0
Czechia
State/province [132] 0 0
Praha
Country [133] 0 0
Czechia
State/province [133] 0 0
Prerov
Country [134] 0 0
Czechia
State/province [134] 0 0
Slany
Country [135] 0 0
Czechia
State/province [135] 0 0
Uherske Hradiste
Country [136] 0 0
Czechia
State/province [136] 0 0
Valasske Mezirici
Country [137] 0 0
Czechia
State/province [137] 0 0
Zlin
Country [138] 0 0
Denmark
State/province [138] 0 0
Aalborg
Country [139] 0 0
Denmark
State/province [139] 0 0
Arhus N
Country [140] 0 0
Denmark
State/province [140] 0 0
Esbjerg
Country [141] 0 0
Denmark
State/province [141] 0 0
Glostrup
Country [142] 0 0
Denmark
State/province [142] 0 0
Herlev
Country [143] 0 0
Denmark
State/province [143] 0 0
Roskilde
Country [144] 0 0
Denmark
State/province [144] 0 0
Viborg
Country [145] 0 0
France
State/province [145] 0 0
Bron
Country [146] 0 0
France
State/province [146] 0 0
Chambray les Tours
Country [147] 0 0
France
State/province [147] 0 0
Compiègne
Country [148] 0 0
France
State/province [148] 0 0
Grenoble Cedex 9
Country [149] 0 0
France
State/province [149] 0 0
Le Coudray
Country [150] 0 0
France
State/province [150] 0 0
Lille
Country [151] 0 0
France
State/province [151] 0 0
Paris
Country [152] 0 0
France
State/province [152] 0 0
St Herblain
Country [153] 0 0
France
State/province [153] 0 0
Toulouse 4
Country [154] 0 0
France
State/province [154] 0 0
Tourcoing
Country [155] 0 0
France
State/province [155] 0 0
Valenciennes
Country [156] 0 0
Germany
State/province [156] 0 0
Baden Wuerttemberg
Country [157] 0 0
Germany
State/province [157] 0 0
Niedersachsen
Country [158] 0 0
Germany
State/province [158] 0 0
Sachsen
Country [159] 0 0
Germany
State/province [159] 0 0
Saxony
Country [160] 0 0
Germany
State/province [160] 0 0
Aachen
Country [161] 0 0
Germany
State/province [161] 0 0
Bad Homburg
Country [162] 0 0
Germany
State/province [162] 0 0
Bad Krozingen
Country [163] 0 0
Germany
State/province [163] 0 0
Bad Oeynhausen
Country [164] 0 0
Germany
State/province [164] 0 0
Bamberg
Country [165] 0 0
Germany
State/province [165] 0 0
Berlin
Country [166] 0 0
Germany
State/province [166] 0 0
Bielefeld
Country [167] 0 0
Germany
State/province [167] 0 0
Chemnitz
Country [168] 0 0
Germany
State/province [168] 0 0
Dessau-Roßlau
Country [169] 0 0
Germany
State/province [169] 0 0
Dortmund
Country [170] 0 0
Germany
State/province [170] 0 0
Dresden
Country [171] 0 0
Germany
State/province [171] 0 0
Essen
Country [172] 0 0
Germany
State/province [172] 0 0
Frankfurt
Country [173] 0 0
Germany
State/province [173] 0 0
Gelnhausen
Country [174] 0 0
Germany
State/province [174] 0 0
Hamburg
Country [175] 0 0
Germany
State/province [175] 0 0
Jena
Country [176] 0 0
Germany
State/province [176] 0 0
Kassel
Country [177] 0 0
Germany
State/province [177] 0 0
Koeln-Nippes
Country [178] 0 0
Germany
State/province [178] 0 0
Koeln
Country [179] 0 0
Germany
State/province [179] 0 0
Kuenzing
Country [180] 0 0
Germany
State/province [180] 0 0
Leipzig
Country [181] 0 0
Germany
State/province [181] 0 0
Loehne
Country [182] 0 0
Germany
State/province [182] 0 0
Lutherstadt Wittenberg
Country [183] 0 0
Germany
State/province [183] 0 0
Lüneburg
Country [184] 0 0
Germany
State/province [184] 0 0
Magdeburg
Country [185] 0 0
Germany
State/province [185] 0 0
Mannheim
Country [186] 0 0
Germany
State/province [186] 0 0
Meißen
Country [187] 0 0
Germany
State/province [187] 0 0
Muehldorf
Country [188] 0 0
Germany
State/province [188] 0 0
Muenchen
Country [189] 0 0
Germany
State/province [189] 0 0
Muenster
Country [190] 0 0
Germany
State/province [190] 0 0
Potsdam
Country [191] 0 0
Germany
State/province [191] 0 0
Rüdersdorf
Country [192] 0 0
Germany
State/province [192] 0 0
Saint Ingbert - Oberwuerzbach
Country [193] 0 0
Germany
State/province [193] 0 0
Ulm
Country [194] 0 0
Germany
State/province [194] 0 0
Warendorf
Country [195] 0 0
Germany
State/province [195] 0 0
Weiden
Country [196] 0 0
Greece
State/province [196] 0 0
GR
Country [197] 0 0
Greece
State/province [197] 0 0
Athens
Country [198] 0 0
Greece
State/province [198] 0 0
Chalkida
Country [199] 0 0
Greece
State/province [199] 0 0
Thessaloniki
Country [200] 0 0
Guatemala
State/province [200] 0 0
Guatemala City
Country [201] 0 0
Guatemala
State/province [201] 0 0
Guatemala
Country [202] 0 0
Hong Kong
State/province [202] 0 0
Hong Kong
Country [203] 0 0
Hong Kong
State/province [203] 0 0
Hongkong
Country [204] 0 0
Hungary
State/province [204] 0 0
Baranya
Country [205] 0 0
Hungary
State/province [205] 0 0
Baja
Country [206] 0 0
Hungary
State/province [206] 0 0
Budapest
Country [207] 0 0
Hungary
State/province [207] 0 0
Debrecen
Country [208] 0 0
Hungary
State/province [208] 0 0
Kistarcsa
Country [209] 0 0
Hungary
State/province [209] 0 0
Mako
Country [210] 0 0
Hungary
State/province [210] 0 0
Mateszalka
Country [211] 0 0
Hungary
State/province [211] 0 0
Miskolc
Country [212] 0 0
Hungary
State/province [212] 0 0
Nyiregyhaza
Country [213] 0 0
Hungary
State/province [213] 0 0
Szeged
Country [214] 0 0
Hungary
State/province [214] 0 0
Szekesfehervar
Country [215] 0 0
Iceland
State/province [215] 0 0
Kopavogur
Country [216] 0 0
Iceland
State/province [216] 0 0
Reykjavik
Country [217] 0 0
India
State/province [217] 0 0
Andhra Pradesh
Country [218] 0 0
India
State/province [218] 0 0
Andhrapradesh
Country [219] 0 0
India
State/province [219] 0 0
Delhi
Country [220] 0 0
India
State/province [220] 0 0
Gujarat
Country [221] 0 0
India
State/province [221] 0 0
Karnataka
Country [222] 0 0
India
State/province [222] 0 0
Kerala
Country [223] 0 0
India
State/province [223] 0 0
Maharashtra
Country [224] 0 0
India
State/province [224] 0 0
Rajasthan
Country [225] 0 0
India
State/province [225] 0 0
Tamil Nadu
Country [226] 0 0
India
State/province [226] 0 0
Telangana
Country [227] 0 0
India
State/province [227] 0 0
Uttar Pradesh
Country [228] 0 0
India
State/province [228] 0 0
Uttarakhand
Country [229] 0 0
India
State/province [229] 0 0
Belgavi
Country [230] 0 0
India
State/province [230] 0 0
Coimbatore
Country [231] 0 0
India
State/province [231] 0 0
New Delhi
Country [232] 0 0
Israel
State/province [232] 0 0
Beer-Sheva
Country [233] 0 0
Israel
State/province [233] 0 0
Haifa
Country [234] 0 0
Israel
State/province [234] 0 0
Jerusalem
Country [235] 0 0
Israel
State/province [235] 0 0
Petach Tikva
Country [236] 0 0
Israel
State/province [236] 0 0
Ramat Gan
Country [237] 0 0
Israel
State/province [237] 0 0
Tel Giborim, Holon
Country [238] 0 0
Italy
State/province [238] 0 0
AN
Country [239] 0 0
Italy
State/province [239] 0 0
BG
Country [240] 0 0
Italy
State/province [240] 0 0
BO
Country [241] 0 0
Italy
State/province [241] 0 0
BS
Country [242] 0 0
Italy
State/province [242] 0 0
FE
Country [243] 0 0
Italy
State/province [243] 0 0
FI
Country [244] 0 0
Italy
State/province [244] 0 0
IS
Country [245] 0 0
Italy
State/province [245] 0 0
MI
Country [246] 0 0
Italy
State/province [246] 0 0
PA
Country [247] 0 0
Italy
State/province [247] 0 0
PG
Country [248] 0 0
Italy
State/province [248] 0 0
PI
Country [249] 0 0
Italy
State/province [249] 0 0
RM
Country [250] 0 0
Italy
State/province [250] 0 0
SA
Country [251] 0 0
Italy
State/province [251] 0 0
VA
Country [252] 0 0
Italy
State/province [252] 0 0
Napoli
Country [253] 0 0
Japan
State/province [253] 0 0
Aichi
Country [254] 0 0
Japan
State/province [254] 0 0
Aomori
Country [255] 0 0
Japan
State/province [255] 0 0
Chiba
Country [256] 0 0
Japan
State/province [256] 0 0
Fukuoka
Country [257] 0 0
Japan
State/province [257] 0 0
Gifu
Country [258] 0 0
Japan
State/province [258] 0 0
Hiroshima
Country [259] 0 0
Japan
State/province [259] 0 0
Ibaraki
Country [260] 0 0
Japan
State/province [260] 0 0
Ishikawa
Country [261] 0 0
Japan
State/province [261] 0 0
Kagawa
Country [262] 0 0
Japan
State/province [262] 0 0
Kanagawa
Country [263] 0 0
Japan
State/province [263] 0 0
Miyagi
Country [264] 0 0
Japan
State/province [264] 0 0
Miyazaki
Country [265] 0 0
Japan
State/province [265] 0 0
Niigata
Country [266] 0 0
Japan
State/province [266] 0 0
Osaka
Country [267] 0 0
Japan
State/province [267] 0 0
Saitama
Country [268] 0 0
Japan
State/province [268] 0 0
Shiga
Country [269] 0 0
Japan
State/province [269] 0 0
Tokyo
Country [270] 0 0
Korea, Republic of
State/province [270] 0 0
Dalseo Gu
Country [271] 0 0
Korea, Republic of
State/province [271] 0 0
Gangwon-Do
Country [272] 0 0
Korea, Republic of
State/province [272] 0 0
Gyeonggi Do
Country [273] 0 0
Korea, Republic of
State/province [273] 0 0
Korea
Country [274] 0 0
Korea, Republic of
State/province [274] 0 0
Seocho Gu
Country [275] 0 0
Korea, Republic of
State/province [275] 0 0
Busan
Country [276] 0 0
Korea, Republic of
State/province [276] 0 0
Gwangju
Country [277] 0 0
Korea, Republic of
State/province [277] 0 0
Incheon
Country [278] 0 0
Korea, Republic of
State/province [278] 0 0
Seoul
Country [279] 0 0
Mexico
State/province [279] 0 0
Morelos
Country [280] 0 0
Mexico
State/province [280] 0 0
Aguascalientes
Country [281] 0 0
Mexico
State/province [281] 0 0
Culiacan Sinaloa
Country [282] 0 0
Mexico
State/province [282] 0 0
Distrito Federal
Country [283] 0 0
Mexico
State/province [283] 0 0
San Luis Potosi
Country [284] 0 0
Netherlands
State/province [284] 0 0
DZ
Country [285] 0 0
Netherlands
State/province [285] 0 0
Gelderland
Country [286] 0 0
Netherlands
State/province [286] 0 0
The Netherlands
Country [287] 0 0
Netherlands
State/province [287] 0 0
Alkmaar
Country [288] 0 0
Netherlands
State/province [288] 0 0
Amersfoort
Country [289] 0 0
Netherlands
State/province [289] 0 0
Amsterdam
Country [290] 0 0
Netherlands
State/province [290] 0 0
Delft
Country [291] 0 0
Netherlands
State/province [291] 0 0
Den Haag
Country [292] 0 0
Netherlands
State/province [292] 0 0
Deventer
Country [293] 0 0
Netherlands
State/province [293] 0 0
Enschede
Country [294] 0 0
Netherlands
State/province [294] 0 0
Gouda
Country [295] 0 0
Netherlands
State/province [295] 0 0
Groningen
Country [296] 0 0
Netherlands
State/province [296] 0 0
Hardenberg
Country [297] 0 0
Netherlands
State/province [297] 0 0
Heemstede
Country [298] 0 0
Netherlands
State/province [298] 0 0
Heerlen
Country [299] 0 0
Netherlands
State/province [299] 0 0
Leiden
Country [300] 0 0
Netherlands
State/province [300] 0 0
Leiderdorp
Country [301] 0 0
Netherlands
State/province [301] 0 0
Nijmegen
Country [302] 0 0
Netherlands
State/province [302] 0 0
Tiel
Country [303] 0 0
Netherlands
State/province [303] 0 0
Tilburg
Country [304] 0 0
Netherlands
State/province [304] 0 0
Utrecht
Country [305] 0 0
Netherlands
State/province [305] 0 0
Venlo
Country [306] 0 0
Netherlands
State/province [306] 0 0
Zwolle
Country [307] 0 0
Norway
State/province [307] 0 0
Oslo
Country [308] 0 0
Norway
State/province [308] 0 0
Skedsmokorset
Country [309] 0 0
Peru
State/province [309] 0 0
Lima
Country [310] 0 0
Poland
State/province [310] 0 0
Malopolskie
Country [311] 0 0
Poland
State/province [311] 0 0
Bielsko-Biala
Country [312] 0 0
Poland
State/province [312] 0 0
Chrzanow
Country [313] 0 0
Poland
State/province [313] 0 0
Gdansk
Country [314] 0 0
Poland
State/province [314] 0 0
Gdynia
Country [315] 0 0
Poland
State/province [315] 0 0
Kedzierzyn Kozle
Country [316] 0 0
Poland
State/province [316] 0 0
Krakow
Country [317] 0 0
Poland
State/province [317] 0 0
Lodz
Country [318] 0 0
Poland
State/province [318] 0 0
Poznan
Country [319] 0 0
Poland
State/province [319] 0 0
Sochaczew
Country [320] 0 0
Portugal
State/province [320] 0 0
Coimbra
Country [321] 0 0
Portugal
State/province [321] 0 0
Guimaraes
Country [322] 0 0
Portugal
State/province [322] 0 0
Setubal
Country [323] 0 0
Puerto Rico
State/province [323] 0 0
Ponce
Country [324] 0 0
Romania
State/province [324] 0 0
Jud Dolj
Country [325] 0 0
Romania
State/province [325] 0 0
Jud Iasi
Country [326] 0 0
Romania
State/province [326] 0 0
Timis
Country [327] 0 0
Romania
State/province [327] 0 0
Baia Mare
Country [328] 0 0
Romania
State/province [328] 0 0
Brasov
Country [329] 0 0
Romania
State/province [329] 0 0
Bucharest
Country [330] 0 0
Romania
State/province [330] 0 0
Bucuresti
Country [331] 0 0
Romania
State/province [331] 0 0
Buzau
Country [332] 0 0
Romania
State/province [332] 0 0
Iasi
Country [333] 0 0
Russian Federation
State/province [333] 0 0
Chelyabinsk
Country [334] 0 0
Russian Federation
State/province [334] 0 0
Ekaterinburg
Country [335] 0 0
Russian Federation
State/province [335] 0 0
Ivanovo
Country [336] 0 0
Russian Federation
State/province [336] 0 0
Izhevsk
Country [337] 0 0
Russian Federation
State/province [337] 0 0
Kemerovo
Country [338] 0 0
Russian Federation
State/province [338] 0 0
Kirov
Country [339] 0 0
Russian Federation
State/province [339] 0 0
Korolev Moscow Region
Country [340] 0 0
Russian Federation
State/province [340] 0 0
Krasnodar
Country [341] 0 0
Russian Federation
State/province [341] 0 0
Moscow
Country [342] 0 0
Russian Federation
State/province [342] 0 0
Novosibirsk
Country [343] 0 0
Russian Federation
State/province [343] 0 0
Perm
Country [344] 0 0
Russian Federation
State/province [344] 0 0
Petrozavodsk
Country [345] 0 0
Russian Federation
State/province [345] 0 0
Rostov On Don
Country [346] 0 0
Russian Federation
State/province [346] 0 0
Ryazan
Country [347] 0 0
Russian Federation
State/province [347] 0 0
Saint Petersburg
Country [348] 0 0
Russian Federation
State/province [348] 0 0
Saint-Petersburg
Country [349] 0 0
Russian Federation
State/province [349] 0 0
Samara
Country [350] 0 0
Russian Federation
State/province [350] 0 0
Saratov
Country [351] 0 0
Russian Federation
State/province [351] 0 0
Sochy
Country [352] 0 0
Russian Federation
State/province [352] 0 0
St Petersburg
Country [353] 0 0
Russian Federation
State/province [353] 0 0
St.- Petersburg
Country [354] 0 0
Russian Federation
State/province [354] 0 0
Tomsk
Country [355] 0 0
Russian Federation
State/province [355] 0 0
Ulyanovsk
Country [356] 0 0
Russian Federation
State/province [356] 0 0
Vsevolozhsk
Country [357] 0 0
Russian Federation
State/province [357] 0 0
Yaroslavl
Country [358] 0 0
Russian Federation
State/province [358] 0 0
Yekaterinburg
Country [359] 0 0
Slovakia
State/province [359] 0 0
Bardejov
Country [360] 0 0
Slovakia
State/province [360] 0 0
Okr Turcianske Teplice
Country [361] 0 0
Slovakia
State/province [361] 0 0
Slovak Republic
Country [362] 0 0
Slovakia
State/province [362] 0 0
SVK
Country [363] 0 0
Slovakia
State/province [363] 0 0
Zilinsky Kraj
Country [364] 0 0
Slovakia
State/province [364] 0 0
Bratislava
Country [365] 0 0
Slovakia
State/province [365] 0 0
Brezno
Country [366] 0 0
Slovakia
State/province [366] 0 0
Dolny Kubin
Country [367] 0 0
Slovakia
State/province [367] 0 0
Komarno
Country [368] 0 0
Slovakia
State/province [368] 0 0
Kosice
Country [369] 0 0
Slovakia
State/province [369] 0 0
Lucenec
Country [370] 0 0
Slovakia
State/province [370] 0 0
Nitra
Country [371] 0 0
Slovakia
State/province [371] 0 0
Nove Zamky
Country [372] 0 0
Slovakia
State/province [372] 0 0
Piestany
Country [373] 0 0
Slovakia
State/province [373] 0 0
Povazska Bystrica
Country [374] 0 0
Slovakia
State/province [374] 0 0
Presov
Country [375] 0 0
Slovakia
State/province [375] 0 0
Rimavska Sobota
Country [376] 0 0
Slovakia
State/province [376] 0 0
Svidnik
Country [377] 0 0
Slovakia
State/province [377] 0 0
Trnava
Country [378] 0 0
Slovenia
State/province [378] 0 0
Ljubljana
Country [379] 0 0
South Africa
State/province [379] 0 0
Gauteng
Country [380] 0 0
South Africa
State/province [380] 0 0
Western Cape
Country [381] 0 0
South Africa
State/province [381] 0 0
Cape Town
Country [382] 0 0
Spain
State/province [382] 0 0
Andalucia
Country [383] 0 0
Spain
State/province [383] 0 0
Barcelona
Country [384] 0 0
Spain
State/province [384] 0 0
Cantabria
Country [385] 0 0
Spain
State/province [385] 0 0
Cataluna
Country [386] 0 0
Spain
State/province [386] 0 0
Catalunya
Country [387] 0 0
Spain
State/province [387] 0 0
Comunidad Valenciana
Country [388] 0 0
Spain
State/province [388] 0 0
Extremadura
Country [389] 0 0
Spain
State/province [389] 0 0
Galicia
Country [390] 0 0
Spain
State/province [390] 0 0
A Coruna
Country [391] 0 0
Spain
State/province [391] 0 0
Huelva
Country [392] 0 0
Spain
State/province [392] 0 0
Madrid
Country [393] 0 0
Spain
State/province [393] 0 0
Zaragoza
Country [394] 0 0
Sweden
State/province [394] 0 0
Goethenburg
Country [395] 0 0
Sweden
State/province [395] 0 0
Lund
Country [396] 0 0
Sweden
State/province [396] 0 0
Stockholm
Country [397] 0 0
Switzerland
State/province [397] 0 0
Basel
Country [398] 0 0
Switzerland
State/province [398] 0 0
Bern
Country [399] 0 0
Switzerland
State/province [399] 0 0
Geneve 14
Country [400] 0 0
Switzerland
State/province [400] 0 0
Lausanne
Country [401] 0 0
Switzerland
State/province [401] 0 0
Liestal
Country [402] 0 0
Switzerland
State/province [402] 0 0
Zuerich
Country [403] 0 0
Taiwan
State/province [403] 0 0
Taiwan ROC
Country [404] 0 0
Taiwan
State/province [404] 0 0
Hsinchu
Country [405] 0 0
Taiwan
State/province [405] 0 0
Kaohsiung
Country [406] 0 0
Taiwan
State/province [406] 0 0
Keelung City
Country [407] 0 0
Taiwan
State/province [407] 0 0
Tainan
Country [408] 0 0
Taiwan
State/province [408] 0 0
Taipei
Country [409] 0 0
Taiwan
State/province [409] 0 0
Taoyuan
Country [410] 0 0
Taiwan
State/province [410] 0 0
Yilan
Country [411] 0 0
Turkey
State/province [411] 0 0
Cankaya
Country [412] 0 0
Turkey
State/province [412] 0 0
Eskisehir
Country [413] 0 0
Turkey
State/province [413] 0 0
Haydarpasa Istanbul
Country [414] 0 0
Turkey
State/province [414] 0 0
Istanbul
Country [415] 0 0
Turkey
State/province [415] 0 0
Izmir
Country [416] 0 0
Turkey
State/province [416] 0 0
Mersin
Country [417] 0 0
Turkey
State/province [417] 0 0
Samsun
Country [418] 0 0
United Kingdom
State/province [418] 0 0
Cleveland
Country [419] 0 0
United Kingdom
State/province [419] 0 0
Dorset
Country [420] 0 0
United Kingdom
State/province [420] 0 0
GBR
Country [421] 0 0
United Kingdom
State/province [421] 0 0
Greater London
Country [422] 0 0
United Kingdom
State/province [422] 0 0
Lancashire
Country [423] 0 0
United Kingdom
State/province [423] 0 0
North Manchester
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Nothern Ireland
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Perthshire
Country [426] 0 0
United Kingdom
State/province [426] 0 0
Somerset
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Surrey
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Swansea
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Tyne And Wear
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Wales
Country [431] 0 0
United Kingdom
State/province [431] 0 0
West Sussex
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Birmingham
Country [433] 0 0
United Kingdom
State/province [433] 0 0
Bournemouth
Country [434] 0 0
United Kingdom
State/province [434] 0 0
Bristol
Country [435] 0 0
United Kingdom
State/province [435] 0 0
Cardiff
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Chesterfield
Country [437] 0 0
United Kingdom
State/province [437] 0 0
Edinburgh
Country [438] 0 0
United Kingdom
State/province [438] 0 0
Glasgow
Country [439] 0 0
United Kingdom
State/province [439] 0 0
Harrow
Country [440] 0 0
United Kingdom
State/province [440] 0 0
Leicester
Country [441] 0 0
United Kingdom
State/province [441] 0 0
Liverpool
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Londonderry
Country [443] 0 0
United Kingdom
State/province [443] 0 0
London
Country [444] 0 0
United Kingdom
State/province [444] 0 0
Manchester
Country [445] 0 0
United Kingdom
State/province [445] 0 0
Middlesbrough
Country [446] 0 0
United Kingdom
State/province [446] 0 0
Middlesex
Country [447] 0 0
United Kingdom
State/province [447] 0 0
Newcastle upon Tyne
Country [448] 0 0
United Kingdom
State/province [448] 0 0
Newport
Country [449] 0 0
United Kingdom
State/province [449] 0 0
Norwich
Country [450] 0 0
United Kingdom
State/province [450] 0 0
Plymouth
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Sheffield
Country [452] 0 0
United Kingdom
State/province [452] 0 0
West Midlands
Country [453] 0 0
United Kingdom
State/province [453] 0 0
Wiltshire
Country [454] 0 0
United Kingdom
State/province [454] 0 0
Wrexham

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a pivotal phase 3 study designed to support an indication for the reduction of
cardiovascular risk in patients with established CVD and elevated Lp(a)
Trial website
https://clinicaltrials.gov/ct2/show/NCT04023552
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/NCT04023552