INCLISIRAN (Inclisiran sodium) for Atherosclerotic cardiovascular disease (ASCVD)

Inclusion criteria

• {"criterion_text":"- Male or female ≥40 years of age\n- Fasting LDL-C ≥1.8 mmol/L (70 mg/dL) at the Screening Visit\n- At the Screening Visit, participants must be on a stable (≥4 weeks) and well-tolerated lipid-lowering regimen (including e.g., with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD\n- Established CV disease, defined as any of the following: - Previous myocardial infarction - Previous ischemic stroke - Symptomatic peripheral arterial disease (PAD), as evidenced by either intermittent claudication with ABI <0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease"}

Exclusion criteria

• {"criterion_text":"- New York Heart Association (NYHA) class III or IV heart failure at the Statin Optimization Screening Visit (if applicable), Screening Visit, or at the Baseline Visit (Day1)\n- Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years prior to the first study visit\n- Pregnant or nursing (lactating) women\n- Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment"}

Primary endpoints

• {"endpoint_text":"- Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke (3P-MACE)","definition_or_measurement_approach":"Time-to-event: time to first occurrence of the composite 3P-MACE (cardiovascular death, non‑fatal MI, non‑fatal ischemic stroke)."}

Secondary endpoints

• {"endpoint_text":"- Time to cardiovascular death","definition_or_measurement_approach":"Time-to-event: time until cardiovascular death."}
• {"endpoint_text":"- Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent coronary revascularization (4P-MACE)","definition_or_measurement_approach":"Time-to-event: time to first occurrence of the composite 4P‑MACE (CV death, non‑fatal MI, non‑fatal ischemic stroke, urgent coronary revascularization)."}
• {"endpoint_text":"- Time to fist occurrence of Major Adverse Limb Events (MALE)","definition_or_measurement_approach":"Time-to-event: time to first occurrence of MALE (major adverse limb events)."}
• {"endpoint_text":"- Time to all-cause death","definition_or_measurement_approach":"Time-to-event: time until death from any cause."}
• {"endpoint_text":"- Number of participants with SAEs","definition_or_measurement_approach":"Count of participants experiencing serious adverse events (SAEs)."}
• {"endpoint_text":"- Number of participants with AEs leading to study treatment discontinuation","definition_or_measurement_approach":"Count of participants with adverse events (AEs) that led to discontinuation of study treatment."}

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA RDS Spain S.L.

Responsibilities

sponsorDuties codes: 1

Name

IQVIA Limited

Responsibilities

sponsorDuties codes: 1, 15 (Endpoint package collection and reporting), 3

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties codes: 1, 12, 2, 5

Name

Syneos Health Inc.

Responsibilities

sponsorDuties codes: 1

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: 1

Name

PRA Hellas CRO A.E.

Responsibilities

sponsorDuties codes: 1

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: 6

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Travel support for patients visit to site (sponsorDuties code 15; value: Travel support for patients visit to site)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Finland","full_name":"Tamro Oyj","duties_or_roles":"IMP delivery and IMP returns (sponsorDuties code 15; value: IMP delivery and IMP returns)","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"IQVIA RDS Spain S.L.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Patient retention (sponsorDuties code 15; value: Patient retention)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Austria","full_name":"Abf Pharmaceutical Services GmbH","duties_or_roles":"Local depot:storage+distribution of AxMP to sites/Destruction (sponsorDuties code 15; value: Local depot:storage+distribution of AxMP to sites/Destruction)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 15 (Endpoint package collection and reporting), 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Datacubed Health Inc.","duties_or_roles":"Patient retention (sponsorDuties code 15; value: Patient retention)","organisation_type":"Pharmaceutical company"}
• {"country":"Slovakia","full_name":"Movianto Slovensko s.r.o.","duties_or_roles":"IMP storage after return from sites and its destruction (sponsorDuties code 15; value: IMP storage after return from sites and its destruction)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Drug distribution, storage, relabeling, return and destruction (sponsorDuties code 15; value: Drug distribution, storage, relabeling, return and destruction)","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive (sponsorDuties code 15; value: TMF archive)","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"Local drug supply (sponsorDuties code 15; value: Local drug supply)","organisation_type":"Pharmaceutical company"}
• {"country":"Iceland","full_name":"Distica hf.","duties_or_roles":"Drug import, delivery to site and destruction of IMP (sponsorDuties code 15; value: Drug import, delivery to site and destruction of IMP)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Latvia","full_name":"Oribalt Riga SIA","duties_or_roles":"Equipment purchases and delivery at site if applicable IMP destruction Local drug supply (sponsorDuties code 15; value: Equipment purchases and delivery at site if applicable IMP destruction Local drug supply)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication committee (sponsorDuties code 15; value: Adjudication committee)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Croatia","full_name":"Medical Intertrade d.o.o.","duties_or_roles":"Import or entry of study drugs and medical equipment, return and destruction of study drugs. (sponsorDuties code 15; value: Import or entry of study drugs and medical equipment, return and destruction of study drugs.)","organisation_type":"Pharmaceutical company"}
• {"country":"Norway","full_name":"Freja Transport & Logistics AS","duties_or_roles":"Drug destruction and re-labeling. (sponsorDuties code 15; value: Drug destruction and re-labeling.)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Syneos Health Clinical Spain S.L.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Rps Research Iberica S.L.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc. (additional entry)","duties_or_roles":"Contact listed with info@medidata.com; sponsorDuties codes: 6","organisation_type":"Non-Pharmaceutical company"}