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 (746) 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: f
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

Locations
United States
Alabama
SEC Clinical Research LLC
Andalusia
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Birmingham
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Huntsville
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Mobile
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Mercy Gilbert Medical Center
Gilbert
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Sun City West
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Tucson
California
Cardiovascular Res Found
Beverly Hills
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Beverly Hills
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Covina
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Huntington Beach
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La Jolla
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Long Beach
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Los Angeles
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Los Angeles
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Northridge
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Orange
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San Diego
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Waterbury
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Fort Lauderdale
East Coast Institute for Research
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Atlanta
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Dunwoody
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Iowa
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Kemerovo
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Kirov
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Korolev Moscow Region
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Krasnodar
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Moscow
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Moscow
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Moscow
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Moscow
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Novosibirsk
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Perm
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Ryazan
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Saint Petersburg
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Saint Petersburg
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Saint Petersburg
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Saint-petersburg
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Samara
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Saratov
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Saratov
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Sochy
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St Petersburg
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Yaroslavl
Slovakia
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Bardejov
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Komarno
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Lucenec
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Presov
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Bournemouth
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Bromwich
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Cardiff
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Cardiff
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Chertsey
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Chesterfield
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Chichester
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Dorchester
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Dundee
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Edinburgh
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Glasgow
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Hardwick
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Harrow
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Leicester
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Liverpool
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London
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London
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London
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Londonderry
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Manchester
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Middlesbrough
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Middlesex
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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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Portadown
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Preston
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Rhyl
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Rochdale
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Sheffield
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Sunderland
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Swansea
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Taunton
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Tyne And Wear
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Wiltshire
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Time Frame
Start Date: 2019-12-12
Completion Date: 2026-02-26
Participants
Target number of participants: 8323
Treatments
Experimental: TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
Placebo_comparator: Placebo
Monthly subcutaneous injections.
Authors
Jennifer G Robinson, Vikram Prasanna, David Sutton Jr, Howard Weintraub, Drew Purdy, Rony Gorges, Jean Foucauld, Daniel Duprez, Karen Aspry, Ghiath Mikdadi, Charles Treasure, Seth Baum, Jalal Ghali, Peter Fail, Adam Schussheim, Anil Chhabra, Christie Ballantyne, Dean Kereiakes, Jeffrey Anderson, Kevin Silver, Ijeoma Isiadinso, Mohsin Alhaddad, Jalal Abbas, Michael Chen, Paul Grena, Marc Bernstein, Paul Rosenblit, Ron Blankstein, Brendan Duffy, Ramin Manshadi, Denzil Moraes, Steven Krueger, Farhad Rafii, Kuruvilla Cheriparambil, William Eaves, Ahmed Arif, John Larry, Alexander White, Tuan-Huy Tran, Abha Khandelwal, Bruce Iteld, Paul Gurbel, Dale Presser, Melvin Martinez-Castrillon, Harry Colfer, Eulogio Sanchez, Tariq Haddad, Peter Bressler, David Hotchkiss, Vikram Arora, Robert Fishberg, Siby George Ayalloore, Eugenia Gianos, Dennis Bruemmer, Fahed Bitar, Bhola Rama, Freny Mody, Barry Harris, Joseph Soufer, Mary McGowan, Frank Voelker, John Petersen II, Joe L Hargrove, Linda Hemphill, Dylan Steen, Michael Shapiro, MacRae Linton, John Pasquini, Albert Lopez, Peter Fattal, Thomas Knickelbine, Billy Jones, Ferris George, Alan Miller, Shamaila Aslam, Joseph Miller, Herman Cheek, Naseem Jaffrani, Sean Donahoe, Julie Clary, Keith Friedman, John Hallgren, Ernest Thompson, Mehrdad Ariani, Vernon Hunter, Bruce Gebhardt, Felton Anderson, Sidney Gorton, Norman Lepor, Alan Brown, Lois Steele, Ranchhod Khant, Sajan Rao, Joel Landzberg, Jagadeesh Ganji, Mahmoud Atieh, Julian Javier, Parveen Garg, Charles Lovell, Edward Teufel, Paul Thompson, Anthony DeMaria, Jonathan Purnell, Hugh Moore, Archna Bajaj, Thorsten Leucker, Eveline Stock, Jose Vazquez-Tanus, Marjan Mujib, Vishal Gupta
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov