This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
Participants who have completed the parent study EOS visit while still on assigned investigational product.
Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
Participants are receiving another investigational drug or device before the open-label treatment period.
Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
Single group
Pelacarsen (TQJ230)
Drugpelacarsen 80mg s.c. monthly
Number of participants with Adverse events
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the OLE study will be presented
Cumulative number of 4P-MACE over time from OLE study baseline
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented
Cumulative number of 4P-MACE over time from parent study baseline
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the parent study will be presented
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