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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

NCT07625306

Not Yet RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Acute Coronary Syndrome (ACS)

Interventions: Pelacarsen, Placebo

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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