A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT)

Phase 1

Recruiting

• Conditions: Primary prevention of atherosclerotic cardiovascular disease (ASCVD); MedDRA version: 21.1Level: LLTClassification code: 10051615Term: Atherosclerotic cardiovascular disease Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-502779-40-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14494

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed, Male or female =40 but <80 years of age, At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following: a. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis =20% but <50% in the left main coronary artery or stenosis =20% but <70% in any major epicardial coronary artery, or b. Coronary artery calcium (CAC) score obtained by CT-scan =100 Agatston units -determined at anytime before screening, or c. High 10-year ASCVD risk =20%, or d. Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk enhancing factors., If on a background lipid lowering therapy (LLT), the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study., LDL-C =70 mg/dL (=1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit.

Exclusion Criteria

History of major ASCVD event defined as any one of the following: a. Acute coronary syndrome (ACS) in the 12 months prior to randomization, or b. Prior myocardial infarction at any time prior to randomization, or c. Prior ischemic stroke at any time prior to randomization, or d. Symptomatic peripheral artery disease (PAD) as evidenced by either intermittent claudication, previous revascularization, or amputation due to atherosclerotic disease at any time prior to randomization., History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization, Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization, Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization, Active liver disease or hepatic dysfunction, Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab), Pregnant or nursing (lactating) women, Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified