Cardiovascular Disease and Lipoprotein(a)
Conditions
Keywords
Lipoprotein(a),, Lp(a),, cardiovascular disease,, CVD,, myocardial infarction,, stroke,, OLE,, pelacarsen,, open-label
Brief summary
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).
Detailed description
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).
Interventions
pelacarsen 80mg s.c. monthly
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study
Intervention model description
Open-label extension (OLE) study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse events | Up to 36 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline | Up to 36 months | 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 | Up to 36 months | 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 | Up to 36 months | 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 | Up to 36 months | 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 |
| Observed value of Lipoprotein(a) (Lp(a)) | Baseline, Month 3, Month 12, Month 24, Month 36 | Samples for Lp(a) assessment will be collected at the defined time points, analyzed and values reported. |
| Change in Lp(a) compared to baseline of the OLE study | Baseline, Month 3, Month 12, Month 24, Month 36 | Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the OLE study. |
| Change in Lp(a) compared to baseline of the parent study | Baseline, Month 3, Month 12, Month 24, Month 36 | Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the parent study. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed