PELACARSEN for Atherosclerotic cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.\n- Participants who have completed the parent study EOS visit while still on assigned investigational product"}

Exclusion criteria

• {"criterion_text":"- Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study\n- 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\n- Participants are receiving another investigational drug or device before the open-label treatment period\n- Pregnant or nursing (breastfeeding) women\n- Women of childbearing potential unless they are using highly effective methods of contraception"}

Primary endpoints

• {"endpoint_text":"- ● Occurrence of the followings: • Treatment Emergent Adverse Events (TEAEs) • Treatment Emergent Serious Adverse Events (TESAEs) • Treatment discontinuations due to TEAEs/TESAEs","definition_or_measurement_approach":""}
• {"endpoint_text":"- ● TEAEs of special interest Observed value or change/shift from baseline in: • Safety laboratory measures • Vital signs","definition_or_measurement_approach":"Observed value or change/shift from baseline in safety laboratory measures and vital signs; TEAEs of special interest identified and recorded."}

Secondary endpoints

• {"endpoint_text":"- Time to the first occurrence of 4P-MACE from parent study baseline","definition_or_measurement_approach":"Time-to-event analysis from parent study baseline to first 4P-MACE event."}
• {"endpoint_text":"- Time to the first occurrence of 4P-MACE from OLE study baseline","definition_or_measurement_approach":"Time-to-event analysis from OLE study baseline to first 4P-MACE event."}
• {"endpoint_text":"- Cumulative number of 4P-MACE over time from parent study baseline","definition_or_measurement_approach":"Cumulative event counts of 4P-MACE over follow-up time measured from parent study baseline."}
• {"endpoint_text":"- Cumulative number of 4P-MACE over time from OLE study baseline","definition_or_measurement_approach":"Cumulative event counts of 4P-MACE over follow-up time measured from OLE baseline."}
• {"endpoint_text":"- Observed value and change in Lp(a) from the parent study baseline","definition_or_measurement_approach":"Measured Lp(a) values and change from parent study baseline (absolute and/or relative change as recorded)."}
• {"endpoint_text":"- Observed value and change in Lp(a) from the OLE study baseline","definition_or_measurement_approach":"Measured Lp(a) values and change from OLE study baseline (absolute and/or relative change as recorded)."}

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

Treatment randomisation; other sponsor duties (codes reported in CTIS)

Name

Icon Clinical Research Limited

Responsibilities

Clinical research services; adjudication (as listed)

Name

Parexel International (IRL) Limited

Responsibilities

Clinical operations, ancillary supplies and other sponsor duties

Name

PRA Hellas CRO A.E.

Responsibilities

Clinical operations support

Name

Syneos Health Inc.

Responsibilities

Sponsor support functions (code 1)

Name

Labcorp Central Laboratory Services LP

Responsibilities

Central laboratory services

Name

Greenphire LLC

Responsibilities

Reporting of Line Listings to the sites

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1; contact: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Adjudication; sponsorDuties code 6; contact: IMISupport@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"Reporting of Line Listings to the sites; sponsorDuties code 8; contact: andreas.raffeiner@studien-monitor.at","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties code 1; contact: Triona.PriceSmith1@docsglobal.com","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties code 1; contact: ICONGreekAffiliateMailbox@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication; contact: c5research@ccf.org","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Duties include: Ancillary Supplies; sponsorDuties codes 1,12,15; contact: clinicaltrial.enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Reporting of Line Listings to the sites; contact: shaughn.marion@greenphire.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"IQVIA Limited","duties_or_roles":"Treatment Randomisation; contact: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code 4 (laboratory services); contact: ctasubmissions@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code 1; contact: sm_ctis@syneoshealth.com","organisation_type":"Pharmaceutical company"}