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Clinical Trials List

Protocol NumberD7960C00015
Active

2025-07-01 - 2030-12-31

Phase III

Recruiting23

ICD-10I25.10

Atherosclerotic heart disease of native coronary artery without angina pectoris

ICD-9429.2

Cardiovascular disease, unspecified

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

  • Trial Applicant

  • Sponsor

    AZ

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 劉俞旻 Division of Cardiovascular Diseases
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

  • 林柏霖 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 賴堯輝 Division of Cardiovascular Diseases
  • 陳永強 Division of Cardiovascular Diseases
  • 楊翔惟 Division of Cardiovascular Diseases
  • 劉銘恩 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔣俊彥 Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JUN-SING WANG Division of Endocrinology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kang-Ling Wang 臨床試驗科
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 葉仲軒 Division of Cardiovascular Diseases
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

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
  • 陳東藝 Division of Cardiovascular Diseases
  • 何明昀 Division of Cardiovascular Diseases
  • 張捷宇 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪崇烈 Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

  • 林肇鋒 Division of Cardiovascular Diseases
  • 黃文弘 Division of Cardiovascular Diseases
  • 蔡瑞鵬 Division of Cardiovascular Diseases
  • 林岳鴻 Division of Cardiovascular Diseases
  • 簡世杰 Division of Cardiovascular Diseases
  • 宋國慈 Division of Cardiovascular Diseases
  • 吳書豪 Division of Cardiovascular Diseases
  • 藍偉仁 Division of Cardiovascular Diseases
  • 顏志軒 Division of Cardiovascular Diseases
  • 余法昌 Division of Cardiovascular Diseases
  • 蕭智忠 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 杜思德 Division of Endocrinology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃玄禮 Division of Cardiovascular Diseases
Taipei Tzu Chi Hospital

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 CHIH-YUAN WANG Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹玄明 Division of Cardiovascular Diseases
國立陽明交通大學附設醫院

Co-Principal Investigator

  • 黃嵩豪 Division of Cardiovascular Diseases
  • 廖照峰 Division of Cardiovascular Diseases
  • 鄭文涵 Division of Cardiovascular Diseases
  • 李丹英 Division of Cardiovascular Diseases
  • 陳思穎 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳榮福 Division of Endocrinology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

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 朱志勳 Division of Endocrinology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 徐國基 Division of Cardiovascular Diseases
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

  • 鍾伯欣 Division of Cardiovascular Diseases
  • 蔡適吉 Division of Cardiovascular Diseases
  • 莊正彥 Division of Cardiovascular Diseases
  • 林姝含 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃建寧 Division of Endocrinology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 葉衍廷 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王志鴻 Division of Cardiovascular Diseases
Hualien Tzu Chi Hospital

Co-Principal Investigator

  • 張懷仁 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃世忠 Division of Cardiovascular Diseases
Kuang Tien General Hospital

Co-Principal Investigator

  • 劉崢偉 Division of Cardiovascular Diseases
  • 曾敏昇 Division of Cardiovascular Diseases
  • 邱一騏 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林維祥 Division of Cardiovascular Diseases
Tri-Service General Hospital

Co-Principal Investigator

  • 劉文正 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林維祥 Division of Cardiovascular Diseases
三軍總醫院附設基隆民眾診療服務處

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Atherosclerotic Cardiovascular Disease (ASCVD)

Objectives

To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS (the composite of CV death, myocardial infarction [MI], ischaemic stroke, acute lower limb ischemia, major amputation of a vascular aetiology, and urgent arterial revascularisation a)

Test Drug

tablet

Active Ingredient

AZD0780

Dosage Form

110

Dosage

30 mg

Endpoints

Time to first event of any component of
MACE-PLUS

Inclution Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Type of Participant and Disease Characteristics
1 Meets one of the following:
(a) Participants with history of an ASCVD event: Participants ≥ 18 years of age at the
time of signing the ICF with a history of ASCVD defined as ACS within 1 to
12 months prior to randomisation, or large artery ischaemic stroke suspected to be due
to atherosclerotic vascular disease within 1 to 12 months prior to randomisation, or
revascularisation for symptomatic lower limb PAD, and LDL-C ≥ 60 mg/dL
(≥ 1.55 mmol/L).



Additional risk factors based on the level of the screening LDL-C:
o Participants with an LDL-C ≥ 60 mg/dL (≥ 1.55 mmol/L) and < 75 mg/dL
(< 1.9 mmol/L) must have BOTH an Lp(a) ≥ 25 mg/dL (≥ 60 nmol/L) AND at
least one of the other additional risk factors (i to vii) below.
o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one
of the other additional risk factors (i to viii) below.



i) T2DM requiring ongoing medical therapy
ii) Age ≥ 65 years
iii) Symptomatic ASCVD in at least 2 vascular beds (eg, coronary artery disease,
cerebrovascular disease, or PAD)
iv) History of recurrent ASCVD events (eg, multiple ACS, ischaemic strokes, PAD
events, or a combination)
v) Previous above ankle amputation due to PAD
vi) Previous diagnosis of non-end stage CKD (eGFR < 60 mL/min/1.73 m2
[CKD-EPI formula; Delgado et al 2022, Inker et al 2021])
vii) hs-CRP ≥ 2.0 mg/L while asymptomatic and without other explanation (eg,
infection)
viii) Lp(a) ≥ 25 mg/dL (≥ 60 nmol/L)
(b) Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years
of age or female participant ≥ 55 years of age at the time of signing the ICF with
LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) and diagnostic evidence of at least one of the
following disease categories (i, ii, or iii):
i) Significant atherosclerotic artery disease with any one of the following:
a) CAC score ≥ 300
b) Prior arterial revascularisation for atherosclerosis by percutaneous
intervention any time prior to screening
c) Prior coronary artery bypass graft surgery > 5 years prior to screening
d) ABI ≤ 0.85
e) ≥ 50% stenosis in ≥ 2 coronary artery territories, or in ≥ 2 vascular beds
(coronary, carotid, lower extremity).
ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of end-organ
disease (diabetic nephropathy, retinopathy, neuropathy or an ABI outside the
normal range [0.9 to 1.4])
iii) Documented atherosclerosis of less significance: CAC score 100 to < 300 or not
meeting criteria above in i).
For ii) and iii), participants need to have at least one of the additional risk factors (a to
f) below:
a) CKD with eGFR ≤ 45 mL/min/1.73 m2 [CKD-EPI formula; Delgado et al
2022, Inker et al 2021])
b) Current tobacco use

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1 Any underlying known disease, or condition including homozygous familial
hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to
randomisation, that, in the opinion of the investigator, might interfere with the
interpretation of the clinical study results.
2 Any revascularisation procedure planned within the next 3 months.
3 Available imaging assessment within the last 3 years showing either coronary calcium
score of zero, or a coronary computed tomography angiography with no atherosclerosis.
4 Calculated eGFR < 15 mL/min/1.73 m2 (CKD-EPI formula; Delgado et al 2022, Inker et
al 2021) at screening.
5 Uncontrolled severe hypertension: systolic BP > 160 mmHg or diastolic BP > 110 mmHg
as measured at any screening/rescreening visits or at randomisation despite
antihypertensive therapy (based on the mean of the 3 consecutive readings).
6 Severe concomitant non-CV disease with estimated life expectancy < 2 years.
7 Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma) within the
last 5 years.
8 Any laboratory values with the following deviations at screening:
− AST or ALT > 3 × ULN
− TBL > 2 × ULN (except for participants with Gilbert's syndrome where TBL
3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
− Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)
− Creatine kinase > 5 × ULN
− Urine albumin/creatinine ratio ≥ 500 mg/g
9 Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
10 Known history of alcohol and/or drug abuse within the last 5 years.
11 Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
12 Acute ischaemic ASCVD event within 7 days prior to screening.
13 QTcF > 470 msec at randomisation, or with family history of long QT syndrome.
14 High-degree AV-block II-III or sinus node dysfunction with clinically significant sinus
pause untreated with pacemaker.
15 Heart failure with NYHA Class IV.
16 Ventricular arrhythmia requiring treatment.
17 Previously diagnosed hypertrophic obstructive cardiomyopathy or any infiltrative
cardiomyopathy such as sarcoidosis or amyloidosis.
18 Participants with a history of hypersensitivity to drugs with a similar chemical structure.
19 Any uncontrolled or serious disease, or any medical (eg, known major active infection
[eg, hepatitis B and C] or major CV, haematological, renal, metabolic, gastrointestinal,
respiratory, hepatic, or endocrine dysfunction) or surgical condition that, in the opinion of
the investigator, may either interfere with participation in the clinical study and/or put the
participant at significant risk.
20 Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.
21 Inadequately treated hypothyroidism defined as TSH > 1.5 × ULN at screening or
participants whose thyroid replacement therapy was initiated or modified within the last
3 months prior to screening.

The Estimated Number of Participants

  • Taiwan

    440 participants

  • Global

    15100 participants

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