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NCT04023552

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

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

8323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2026-02-26

Brief Summary

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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)

Detailed Description

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Conditions

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Cardiovascular Disease and Lipoprotein(a)

Keywords

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Lipoprotein(a), Lp(a), CVD, myocardial infarction, PAD, Stroke, Pelacarsen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TQJ230

TQJ230 80 mg injected monthly administered subcutaneously

Group Type EXPERIMENTAL

TQJ230

Intervention Type DRUG

TQJ230 80 mg injected monthly administered subcutaneously

Placebo

Monthly subcutaneous injections.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Interventions

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TQJ230

TQJ230 80 mg injected monthly administered subcutaneously

Intervention Type DRUG

Placebo

Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Intervention Type DRUG

Other Intervention Names

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Placebo to match TQJ230

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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Philippines United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Colombia Czechia Denmark France Germany Greece Guatemala Hong Kong Hungary Iceland India Israel Italy Japan Mexico Netherlands Norway Peru Poland Portugal Puerto Rico Romania Russia Slovakia Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Turkey (Türkiye) United Kingdom

Reference Type DERIVED

PMID: 34232223 (View on PubMed)

Other Identifiers

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CTQJ230A12301

Identifier Type: OTHER

Identifier Source: secondary_id

2019-001076-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTQJ230A12301

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

TQJ230

TQJ230

Placebo

Placebo

Interventions

TQJ230

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novartis Pharmaceuticals

Responsible Party

Principal Investigators

Novartis Pharmaceuticals

Locations

SEC Clinical Research LLC

Grandview Med Group Research LLC

Novartis Investigative Site

Heart Center Research Llc

Novartis Investigative Site

Mobile Heart Specialists

Novartis Investigative Site

Novartis Investigative Site

Mercy Gilbert Medical Center

Clinical Research Inst of Arizona

Novartis Investigative Site

Eclipse Clinical Research

Novartis Investigative Site

Cardiology and Medicine Clinic PA

Novartis Investigative Site

Cardiovascular Res Found

National Heart Institute

Novartis Investigative Site

Flourish Clinical Resrch Covin

Novartis Investigative Site

Diabetes Lipid Management Center

Novartis Investigative Site

University of Calif Irvine Med Cntr

Novartis Investigative Site

Memorial Care Health System

Novartis Investigative Site

Keck Medical Center USC

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Valley Clinical Trials

Novartis Investigative Site

Stanford University Medical Center

University of California San Diego

UCSF

Novartis Investigative Site

Helping Hands Medical Associates INC

Novartis Investigative Site

Novartis Investigative Site

Manshadi Heart Institute

Novartis Investigative Site

Interv Cardiology Med Grp

Novartis Investigative Site

Novartis Investigative Site

Univ Of Color Anschutz Med Center

Bridgeport Hospital

Novartis Investigative Site

Novartis Investigative Site

Hartford Hospital

Chase Medical Research LLC

Novartis Investigative Site

Excel Medical Clinical Trials LLC

Novartis Investigative Site

Cardiovascular and Vein Center of Florida