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Not yet recruiting NCT07625306

Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL

Phase III Interventional Acute Coronary Syndrome (ACS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pelacarsen, Placebo.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome (ACS). Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Pelacarsen
    Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
  • Drug Placebo
    Placebo subcutaneously (s.c.) once a month (QM)

Primary outcome measures

  • Change in log-transformed Lp(a) concentration [Time frame: Baseline, Day 180]
Secondary outcome measures (9)
  • Proportion of participants with Lp(a) < 105 nmol/L [Time frame: Day 180 and Day 540]
  • Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest [Time frame: 22 months]
  • Summary of observed values for Glomerular Filtration Rate (GFR) [Time frame: Up to 18 months]
  • Change from baseline in Glomerular Filtration Rate (GFR) [Time frame: Baseline and up to 18 months]
  • Summary of observed values for Heart Rate (HR) [Time frame: Up to 18 months]
  • Change from baseline in Heart Rate (HR) [Time frame: Baseline and up to 18 months]
  • Summary of observed values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Time frame: Up to 18 months]
  • Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Time frame: Baseline and up to 18 months]
  • Change from baseline to Day 540 in non-calcified coronary plaque volume [Time frame: Baseline and Day 540]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07625306 · CTQJ230A1US13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗