Phase
Condition
Atherosclerosis
Vascular Diseases
Chest Pain
Treatment
Dose 2 YN001
Dose 1 YN001
Evolocumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Fully understand the purposes, features, and methods of the study, and sign the ICFbefore performing any assessment.
Male or female Australia patients between 18 and 75 years.
Patients diagnosed with coronary atherosclerosis, and at least 1 vessel withdiameter stenosis determined by coronary computed tomography angiography (CTA).
Female patients must be non-pregnant and non-lactating, and females of childbearingpotential (including a female partner of a male patient) must agree to use 1effective contraception method from the screening period to 3 months after receivingtheir last dose of the study drug. In addition, male patients must be willing torefrain from sperm donation during this time.
Willing and able to comply with the requirements of protocol to the best of thepatient's and investigator's knowledge.
Exclusion
Exclusion Criteria:
Prior treatment with other investigational drug(s) within 30 days or 5 half-lives,whichever is longer, prior to randomization.
Previously received YN001.
Any type of vaccination within 4 weeks prior to randomization.
Contraindication for coronary CTA (e.g., known history of anaphylactic contrastreactions).
Severe coronary calcification.
Multi-vessel severe disease.
Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2weeks prior to randomization.
Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3months, such as ventricular tachycardia, atrial fibrillation with rapid ventricularrate and paroxysmal supraventricular tachycardia.
Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, hearttransplantation, SAVR/TAVR, etc., is required or planned during the study.
PCI performed within 4 weeks prior to randomization or PCI is required or plannedduring study treatment.
New York Heart Association (NYHA) class III or IV, or last known left ventricularejection fraction (LVEF) <40%.
Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
Evidence of major diseases that not recovered within 2 weeks prior to randomization,or major surgery is expected during the study.
Presenting with history of malignancy (except in patients who have been disease-free >5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).
Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensivetherapy.
Active liver disease or hepatic dysfunction defined by any of ALT, AST, or totalbilirubin > 2 times upper limit of normal (ULN) at final screening.
Presence of renal insufficiency.
Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.
A positive hepatitis B surface antigen (HBsAg), or positive antibody againsthepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positivetreponema pallidum antibody (TP-Ab).
Presence of any other diseases or conditions (apart from those outlined above) that,in the opinion of the investigator, would make it unsuitable for the patient toparticipate in this study.
Study Design
Study Description
Connect with a study center
Canberra Hospital
Canberra, Australian Capital Territory
AustraliaSite Not Available
Albury Wodonga Private Hospital
Albury, New South Wales 1125
AustraliaSite Not Available
Core Research Group Pty Ltd
Milton, Queesland
AustraliaActive - Recruiting
Altona Clinical Research
Melbourne, Victoria 3025
AustraliaSite Not Available
Peninsula Heart Centre
Melbourne, Victoria 3199
AustraliaActive - Recruiting
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