Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

ClinicalTrials.gov Identifier: NCT04023552

Novartis Reference Number: CTQJ230A12301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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)

Condition 
Cardiovascular Disease and Lipoprotein(a)
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
7680 participants
Start date 
Dec 12, 2019
Completion date 
Jun 10, 2024
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
Drug
Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Eligibility 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 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 Locations

United States
Novartis Investigative Site
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Andalusia, 36420
Alabama
United States
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Birmingham, 35243
Alabama
United States
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Huntsville, 35801
Alabama
United States
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Mobile, 36608
Alabama
United States
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Cottonwood, 86326
Arizona
United States
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Surprise, 85374
Arizona
United States
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Tucson, 85745
Arizona
United States
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Little Rock, 72204
Arkansas
United States
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Beverly Hills, 90211
California
United States
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Covina, 91723
California
United States
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Northridge, 91325
California
United States
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West Hills, 91307
California
United States
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Boca Raton, 33434
Florida
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Bradenton, 34209
Florida
United States
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Brandon, 33511
Florida
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Fort Lauderdale, 33312
Florida
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Jacksonville, 32216
Florida
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Naples, 34102
Florida
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Port Charlotte, 33952
Florida
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Port Orange, 32127
Florida
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Wellington, 33449
Florida
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Kansas City, 66160
Kansas
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Alexandria, 71301
Louisiana
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Covington, 70433
Louisiana
United States
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Hammond, 70403
Louisiana
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Houma, 70360
Louisiana
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Metairie, 70006
Louisiana
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Slidell, 70458
Louisiana
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Zachary, 70791
Louisiana
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Wyoming, 49519
Michigan
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Yazoo City, 39194
Mississippi
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Saint Peters, 63303
Missouri
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Omaha, 68134
Nebraska
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Binghamton, 13901
New York
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Canton, 44710
Ohio
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Cincinnati, 45246
Ohio
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Rapid City, 57701
South Dakota
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Jackson, 38301
Tennessee
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Knoxville, 37917
Tennessee
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Beaumont, 77702
Texas
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Dallas, 75231
Texas
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Houston, 77030
Texas
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Livingston, 77351
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Marshall, 75670
Texas
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Tomball, 77375
Texas
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Bountiful, 84010
Utah
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Layton, 84041
Utah
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Virginia
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Graz, 8036
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Innsbruck, 6020
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Linz, 4021
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Salzburg, A-5020
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Bad Gottleuba, 01816
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Dresden, 01099
Sachsen
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Aachen, 52074
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Bad Homburg, 61348
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Bad Krozingen, 79189
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Bad Oeynhausen, 32545
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Bamberg, 96049
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Berlin, 10367
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Berlin, 10787
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Berlin, 13347
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Berlin, 13353
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Bielefeld, 33604
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Chemnitz, 09122
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Dessau-Roßlau, 06846
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Dortmund, 44137
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Dresden, 01069
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Dresden, 01277
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Dresden, 01307
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Essen, 45277
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Essen, 45355
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Essen, 45359
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Frankfurt, 60590
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Frankfurt, 60594
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Gelnhausen, 63571
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Hamburg, 22041
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Hamburg, 22607
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Jena, 07740
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Kassel, 34121
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Kleve, 47533
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Koeln-Nippes, 50733
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Koeln, 50937
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Kuenzing, 94550
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Leipzig, 04103
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Leipzig, 04109
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Loehne, 32584
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Lutherstadt Wittenberg, 06886
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Lüneburg, 21339
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Magdeburg, 39120
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Mannheim, 68165
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Meißen, 01662
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Muehldorf, 84453
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Muenchen, 80636
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Muenchen, 81377
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Muenster, 48149
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Northeim, 37154
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Potsdam, 14471
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Rüdersdorf, 15562
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