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Clinical Trials/NCT07625306
NCT07625306Not yet recruitingPhase 3

A Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability, and Coronary Plaque Effects of Early Pelacarsen (TQJ230) Initiation in Patients in the US With Elevated Lp(a) and Recent Acute Coronary Syndrome

Novartis Pharmaceuticals0 sites240 target enrollmentStarted: August 31, 2026Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
240
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in participants with elevated Lp(a) and recent acute coronary syndrome (ACS).

Detailed Description

This study consists of Lp(a) measurement and additional screening assessments, a double-blind treatment period of 18 months, and a 16-week safety follow up period from the last dose. Efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo will be assessed throughout the study, with primary analysis at Day 180 and final analysis at Day 540.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Lp(a) ≥ 150 nmol/L
  • •Within 10 days of hospitalization for ACS event and meets all of the following criteria:
  • •Clinical syndrome consistent with spontaneous cardiac ischemia
  • •Diagnosis of ACS: ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)

Exclusion Criteria

  • •Uncontrolled hypertension
  • •Heart failure New York Heart Association (NYHA) class IV
  • •History of malignancy of any organs
  • •History of hemorrhagic stroke or other major bleeding
  • •Platelet count ≤ LLN
  • •Active liver disease or hepatic dysfunction
  • •Significant kidney disease
  • •Contraindication for CCTA or severe contrast allergy
  • •Pregnant or nursing women
  • •Other protocol-defined inclusion/exclusion criteria may apply

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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