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Clinical Trials List

Protocol NumberCKJX839D12302
NCT Number(ClinicalTrials.gov Identfier)NCT05739383
Active

2023-04-01 - 2032-12-31

Phase III

Recruiting9

ICD-10I70.0

Atherosclerosis of aorta

ICD-9440.0

Atherosclerosis of aorta

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)

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Kang-Ling Wang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang Division of Cardiovascular Diseases
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

  • 葉日凱 Division of Cardiovascular Diseases
  • 陳怡文 Division of Cardiovascular Diseases
  • 陳俊吉 Division of Cardiovascular Diseases
  • 何明昀 Division of Cardiovascular Diseases
  • 陳東藝 Division of Cardiovascular Diseases
  • 林怡瑄 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases
  • 劉鳳炫 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 翁國昌 Division of Cardiovascular Diseases
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏建勳 Division of Cardiovascular Diseases
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

  • 杜思德 Division of Cardiovascular Diseases
  • 簡思齊 Division of Cardiovascular Diseases
  • 蘇矢立 Division of Cardiovascular Diseases
  • 黃宏凱 Division of Cardiovascular Diseases
  • 楊秉忠 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Zhih-Cherng Chen Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Primary Prevention of Atherosclerotic Cardiovascular Disease

Objectives

Trial CKJX839D12302 is a pivotal Phase 3 trial designed to identify a false hypothesis, that is, for patients with high cardiovascular (CV) risk but no history of major atherosclerosis. Patients with cardiovascular disease (ASCVD) events on day 1, day 90, and every 6 Once monthly subcutaneous injection (s.c.) of inclisiran sodium 300 mg (mg) is used for treatment. Compared with placebo, it can significantly reduce the occurrence of 4 major adverse cardiovascular events (4P-MACE) risk, defined as cardiovascular death, nonfatal myocardial infarction (MI), nonfatal ischemia Comprehensive index of stroke and emergency coronary revascularization.

Test Drug

KJX839 (Inclisiran)

Active Ingredient

KJX839 (Inclisiran)

Dosage Form

solution for injection in pre-filled syringe

Dosage

284

Endpoints

Inclisiran was shown to be effective compared to placebo in reducing the risk of the 4P-MACE composite (including cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization).
Time of first occurrence of 4P-MACE

Inclution Criteria

Inclusion Criteria:

At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:

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 other major epicardial coronary artery, or
Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
High 10-year ASCVD risk ≥20%, or
Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, 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.

Exclusion Criteria

Exclusion Criteria:

History of major ASCVD event.
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

The Estimated Number of Participants

  • Taiwan

    400 participants

  • Global

    14000 participants

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