PELACARSEN for Cardiovascular disease | Arteriosclerotic cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Lp(a) ≥ 70 mg/dL at the screening visit"}
• {"criterion_text":"- Optimal LDL-cholesterol lowering treatment"}
• {"criterion_text":"- Myocardial infarction: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or"}
• {"criterion_text":"- Ischemic stroke: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or"}
• {"criterion_text":"- Clinically significant symptomatic peripheral artery disease"}

Exclusion criteria

• {"criterion_text":"- Uncontrolled hypertension"}
• {"criterion_text":"- Heart failure New York Heart Association (NYHA) class IV"}
• {"criterion_text":"- History of malignancy of any organ system"}
• {"criterion_text":"- History of hemorrhagic stroke or other major bleeding"}
• {"criterion_text":"- Platelet count <140,000 per mm3"}
• {"criterion_text":"- Active liver disease or hepatic dysfunction"}
• {"criterion_text":"- Significant kidney disease"}
• {"criterion_text":"- Pregnant or nursing women"}

Primary endpoints

• {"endpoint_text":"- Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL","definition_or_measurement_approach":"Time-to-event endpoint measured as time from randomization to first CEC (Clinical Endpoint Committee)–adjudicated occurrence of expanded MACE (cardiovascular death, nonfatal myocardial infarction, non-fatal stroke, urgent coronary revascularization requiring hospitalization). Events are confirmed by the CEC."}
• {"endpoint_text":"- Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a subpopulation of patients with elevated Lp(a) ≥ 90 mg/dL","definition_or_measurement_approach":"Time-to-event endpoint measured in the Lp(a) ≥ 90 mg/dL subpopulation; CEC adjudication as above."}

Secondary endpoints

• {"endpoint_text":"- Time to the first occurrence of the CEC confirmed composite endpoint of MACE (CV death, non-fatal MI, and non-fatal stroke)","definition_or_measurement_approach":"Time from randomization to first CEC-adjudicated occurrence of composite MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)."}
• {"endpoint_text":"- Time to the first occurrence of the CEC confirmed composite endpoint of CHD: CHD death, non-fatal MI, urgent coronary revascularization requiring hospitalization","definition_or_measurement_approach":"Time-to-event measured as time from randomization to first CEC-adjudicated coronary heart disease composite event (death due to CHD, non-fatal MI, urgent coronary revascularization requiring hospitalization)."}
• {"endpoint_text":"- Change in Lp(a) in the log scale from baseline at 1 year","definition_or_measurement_approach":"Change from baseline in Lp(a) level on the logarithmic scale at 1 year; measured in central laboratory."}
• {"endpoint_text":"- Time to CEC confirmed all-cause death","definition_or_measurement_approach":"Time from randomization to death from any cause, confirmed by the CEC."}

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Supplies for injector training, home administration kits; operational/clinical support (listed duties include supplies and operational support).

Name

ICON Clinical Research Limited

Responsibilities

Operational support and endpoint adjudication responsibilities (endpoint adjudication noted).

Name

PRA Hellas CRO A.E.

Responsibilities

Operational support (sponsor duties code '1' listed).

Name

IQVIA Limited

Responsibilities

Operational and clinical trial information support (multiple duties; contact eu_clinical_trials_information@iqvia.com listed).

Name

Syneos Health Inc.

Responsibilities

Operational support duties (code '1' listed in sponsor third parties).

Third parties

• {"country":"United States","full_name":"Qualitymetric Incorporated LLC","duties_or_roles":"ePRO scoring","organisation_type":"Pharmaceutical company"}
• {"country":"Austria","full_name":"Abf Pharmaceutical Services GmbH","duties_or_roles":"Local depot: storage/distribution AxMP, reconciliation and destruction of unused IMP and AxMP at EoT","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Supplies for Injector training, as well and home administration kits (Cooler packs, Sharps container","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Sponsor duty code '1' (role code present in record) — specific duty not detailed in metadata","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties include endpoint adjudication and other operational support (codes '1' and '15' present)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Kayentis","duties_or_roles":"ePRO/eCOA vendor duties (code '7')","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Slovenia","full_name":"SALUS Veletrgovina druzba za promet s farmacevtskimi medicinskimi in drugimi proizvodi d.o.o.","duties_or_roles":"Collection and destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"DMC Oversight, Adjudication Oversight","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Bulgaria","full_name":"World Courier Bulgaria EOOD","duties_or_roles":"IMPD transportation from sites","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Sweden","full_name":"Oriola Sweden AB","duties_or_roles":"Logistics / product distribution related duties (code '14')","organisation_type":"Pharmaceutical company"}
• {"country":"Slovakia","full_name":"Movianto Slovensko s.r.o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"Patient compensation","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Operational support (code '1')","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Operational support (code '1')","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"Drug warehousing and distribution, pass-through depot and return medication","organisation_type":"Pharmaceutical company"}
• {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"Monitoring activities (code '8')","organisation_type":"Pharmaceutical company"}
• {"country":"Norway","full_name":"Freja Transport & Logistics AS","duties_or_roles":"Drug destruction and re-labeling","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO Translation, ePRO licensing, and eCOA migration","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Movianto Belgium","duties_or_roles":"Optional destruction of IMP in case it cannot be destructed at hospital pharmacy level","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive Activation sites activities","organisation_type":"Pharmaceutical company"}
• {"country":"Bulgaria","full_name":"S & D Pharma Logistics BG EOOD","duties_or_roles":"Storage and destruction of IMP","organisation_type":"Pharmaceutical company"}
• {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
• {"country":"Iceland","full_name":"Distica hf.","duties_or_roles":"Import, delivery, destruction of IMP","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited (second listing)","duties_or_roles":"Central operational support (code '12' in some listings)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Centralised taxi and airfare service","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Retention material","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited (second listing)","duties_or_roles":"Operational support (code '3' in some listings)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Eurofins Genomics Europe Applied Genomics GmbH","duties_or_roles":"Genomic testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"Movianto Belgium (second listing)","duties_or_roles":"Optional destruction of IMP in case it cannot be destructed at hospital pharmacy level","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Opis S.r.l. (second listing)","duties_or_roles":"Drug warehousing and distribution, pass-through depot and return medication","organisation_type":"Pharmaceutical company"}
• {"country":"Bulgaria","full_name":"S & D Pharma Logistics BG EOOD (second listing)","duties_or_roles":"Storage and destruction of IMP","organisation_type":"Pharmaceutical company"}