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

Who is this study for? Patients with Cardiovascular Disease and Lipoprotein
What treatments are being studied? TQJ230
Status: Active, not recruiting
Location: See all (749) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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

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United States
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Novartis Investigative Site
Ekaterinburg
Novartis Investigative Site
Ekaterinburg
Novartis Investigative Site
Ivanovo
Novartis Investigative Site
Izhevsk
Novartis Investigative Site
Kemerovo
Novartis Investigative Site
Kirov
Novartis Investigative Site
Korolev Moscow Region
Novartis Investigative Site
Krasnodar
Novartis Investigative Site
Moscow
Novartis Investigative Site
Moscow
Novartis Investigative Site
Moscow
Novartis Investigative Site
Moscow
Novartis Investigative Site
Moscow
Novartis Investigative Site
Moscow
Novartis Investigative Site
Novosibirsk
Novartis Investigative Site
Perm
Novartis Investigative Site
Petrozavodsk
Novartis Investigative Site
Rostov On Don
Novartis Investigative Site
Ryazan
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Saint-petersburg
Novartis Investigative Site
Samara
Novartis Investigative Site
Saratov
Novartis Investigative Site
Saratov
Novartis Investigative Site
Sochy
Novartis Investigative Site
St Petersburg
Novartis Investigative Site
St Petersburg
Novartis Investigative Site
St Petersburg
Novartis Investigative Site
St Petersburg
Novartis Investigative Site
St.- Petersburg
Novartis Investigative Site
Tomsk
Novartis Investigative Site
Ulyanovsk
Novartis Investigative Site
Vsevolozhsk
Novartis Investigative Site
Yaroslavl
Novartis Investigative Site
Yekaterinburg
Slovakia
Novartis Investigative Site
Banska Bystrica
Novartis Investigative Site
Bardejov
Novartis Investigative Site
Bardejovske Kupele
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Brezno
Novartis Investigative Site
Dolny Kubin
Novartis Investigative Site
Handlova
Novartis Investigative Site
Komarno
Novartis Investigative Site
Komarno
Novartis Investigative Site
Kosice
Novartis Investigative Site
Kosice
Novartis Investigative Site
Lucenec
Novartis Investigative Site
Nitra
Novartis Investigative Site
Nitra
Novartis Investigative Site
Nitra
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Nove Zamky
Novartis Investigative Site
Nove Zamky
Novartis Investigative Site
Piestany
Novartis Investigative Site
Povazska Bystrica
Novartis Investigative Site
Presov
Novartis Investigative Site
Rimavska Sobota
Novartis Investigative Site
Rimavska Sobota
Novartis Investigative Site
Roznava
Novartis Investigative Site
Svidnik
Novartis Investigative Site
Trnava
Novartis Investigative Site
Turcianske Teplice
Novartis Investigative Site
Zilina
Slovenia
Novartis Investigative Site
Ljubljana
South Africa
Novartis Investigative Site
Cape Town
Novartis Investigative Site
Cape Town
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Cape Town
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Cape Town
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George
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Soweto
Spain
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A Coruna
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Badalona
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Barcelona
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Barcelona
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Caceres
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Cordoba
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Hospitalet De Llobregat
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Huelva
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Madrid
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Madrid
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Malaga
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Reus
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Santander
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Santiago De Compostela
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Sevilla
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Sevilla
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Sevilla
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Valencia
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Zaragoza
Sweden
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Goethenburg
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Lund
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Stockholm
Switzerland
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Basel
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Bern
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Geneve 14
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Lausanne
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Liestal
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Zuerich
Taiwan
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Hsinchu
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Kaohsiung
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Kaohsiung City
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Keelung City
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Taichung
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Tainan
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Taipei
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Taoyuan
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Yilan
Turkey
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Ankara
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Haydarpasa Istanbul
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Istanbul
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Izmir
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Izmir
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Mersin
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Meselik
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Samsun
United Kingdom
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Birmingham
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Bournemouth
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Bristol
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Cardiff
Novartis Investigative Site
Cardiff
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Chertsey
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Chesterfield
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Chichester
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Dorchester
Novartis Investigative Site
Dundee
Novartis Investigative Site
Edinburgh
Novartis Investigative Site
Glasgow
Novartis Investigative Site
Harrow
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Leicester
Novartis Investigative Site
Liverpool
Novartis Investigative Site
London
Novartis Investigative Site
London
Novartis Investigative Site
London
Novartis Investigative Site
Londonderry
Novartis Investigative Site
Manchester
Novartis Investigative Site
Middlesbrough
Novartis Investigative Site
Middlesex
Novartis Investigative Site
Newcastle Upon Tyne
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Newport
Novartis Investigative Site
Norwich
Novartis Investigative Site
Plymouth
Novartis Investigative Site
Portadown
Novartis Investigative Site
Preston
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Rhyl
Novartis Investigative Site
Rochdale
Novartis Investigative Site
Sheffield
Novartis Investigative Site
Sketty
Novartis Investigative Site
Stockton On Tees
Novartis Investigative Site
Sunderland
Novartis Investigative Site
Taunton
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Tyne And Wear
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West Midlands
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Wiltshire
Novartis Investigative Site
Wrexham
Time Frame
Start Date: December 12, 2019
Estimated Completion Date: May 30, 2025
Participants
Target number of participants: 8324
Treatments
Experimental: TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
Placebo Comparator: Placebo
Monthly subcutaneous injections.
Authors
Vikram Prasanna, David Sutton Jr, Howard Weintraub, Drew Purdy, Rony Gorges, Amit Shah, Jean Foucauld, Paul Thompson, Samuel Kim, Alan Miller, Daniel Duprez, Karen Aspry, Ghiath Mikdadi, Charles Treasure, Seth Baum, Jalal Ghali, Peter Fail, Adam Schussheim, Anil Chhabra, Christie Ballantyne, Dean Kereiakes, Benjamin Hirsch, Kevin Silver, Ijeoma Isiadinso, Mohsin Alhaddad, Jalal Abbas, Paul Grena, Marc Bernstein, Edward Teufel, Paul Rosenblit, Ron Blankstein, Anne Goldberg, Brendan Duffy, Ramin Manshadi, Gary Miller, Steven Krueger, Michael Koren, Farhad Rafii, Kuruvilla Cheriparambil, William Eaves, John Larry, Alexander White, Tuan-Huy Tran, Abha Khandelwal, Bruce Iteld, Paul Gurbel, Jonathan Purnell, Alan Charles Schwartz, Dale Presser, Thorsten Leucker, Harry Colfer, Eulogio Sanchez, Jeffrey Anderson, Tariq Haddad, Peter Bressler, David Hotchkiss, Michael Miller, Jose Vazquez-Tanus, Robert Fishberg, Stephen Jones, Siby George Ayalloore, Eugenia Gianos, Alan Brown, Dennis Bruemmer, Fahed Bitar, Bhola Rama, Marjan Mujib, Vikram Arora, Freny Mody, Barry Harris, Joseph Soufer, Julie Clary, Archna Bajaj, Richard Jackson, Mary McGowan, Patrick Moriarty, Frank Voelker, Joe L Hargrove, Michael Chen, Hugh Moore, Linda Hemphill, Dylan Steen, Jennifer G Robinson, MacRae Linton, John Pasquini, Eveline Stock, Albert Lopez, Anthony DeMaria, Peter Fattal, Michael Cox, Thomas Knickelbine, Billy Jones, Ferris George, Shamaila Aslam, Charles Lovell, Robert Rosenson, Herman Cheek, Naseem Jaffrani, Sean Donahoe, Keith Friedman, John Hallgren, Ernest Thompson, Mehrdad Ariani, Vernon Hunter, Bruce Gebhardt, Felton Anderson, Sidney Gorton, Norman Lepor, Vishal Gupta, Lois Steele, Ranchhod Khant, Sajan Rao, Michael Shapiro, Frank McGrew, Joel Landzberg, Jagadeesh Ganji, Mahmoud Atieh, Dharmesh Patel, Julian Javier, Parveen Garg, Joseph Miller, Christopher Brown, Marc Cornier, Joshua Oaks, Ronald Sklash, Randall Miller, Brian O Neil, D Eric Bolster, Sam Butman, Eduardo Rodriguez Araya, Tim Smith, Xue-Qiao Zhao, Thomas Vanhecke, Ahmed Arif, Chrisette Dharma, Anthony DeFranco, Cara East, Kelley Branch, Christopher Daniels, Ailin Barseghian El-Farra, John Petersen II, Denzil Moraes, Melvin Martinez-Castrillon, Khaled Nour
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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