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).
Lp(a) ≥ 150 nmol/L
Clinical syndrome consistent with spontaneous cardiac ischemia
Diagnosis of ACS: ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)
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
Parallel
Pelacarsen
DrugPelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
Placebo
DrugPlacebo subcutaneously (s.c.) once a month (QM)
Change in log-transformed Lp(a) concentration
Change in log-transformed Lipoprotein A (Lp(a)) concentration from baseline to Day 180
Proportion of participants with Lp(a) < 105 nmol/L
Proportion of participants with Lipoprotein A (Lp(a)) \< 105 nmol/L
Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest
Proportion of participants with: * Treatment-emergent adverse events (TEAEs) * Treatment-emergent serious adverse events (TESAEs) * TEAEs or TESAEs leading to study drug discontinuation * TEAEs of special interest
Summary of observed values for Glomerular Filtration Rate (GFR)
Summary of observed values in GFR (Safety laboratory parameters)
Change from baseline in Glomerular Filtration Rate (GFR)
Change from baseline in GFR (Safety laboratory parameters)
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