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Clinical Trials List

Protocol NumberD7960C00015
NCT Number(ClinicalTrials.gov Identfier)NCT07000357
Active

2025-07-01 - 2030-12-31

Recruiting23

ICD-10I25.10

Atherosclerotic heart disease of native coronary artery without angina pectoris

ICD-9429.2

Cardiovascular disease, unspecified

A phase III, randomized, double-blind, placebo-controlled, parallel-group trial was conducted to evaluate the efficacy of AZD0780 in patients with established atherosclerotic cardiovascular disease (ASCVD) or at high risk of first ASCVD events for major adverse cardiovascular events.

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/23

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
  • 劉銘恩 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 楊翔惟 Division of Cardiovascular Diseases
  • 陳永強 Division of Cardiovascular Diseases
  • 賴堯輝 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 洪崇烈 Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

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

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

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 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

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
  • 邱一騏 Division of Cardiovascular Diseases
  • 曾敏昇 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
Kaohsiung Municipal Ta-Tung Hospital

Co-Principal Investigator

  • 張健偉 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

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

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Patients with established atherosclerotic cardiovascular disease or at high risk of their first atherosclerotic cardiovascular event.

Objectives

This is a phase III, randomized, double-blind, placebo-controlled, parallel-group, event-driven trial evaluating the efficacy of AZD0780 for MACE-PLUS (a composite measure of cardiovascular death, myocardial infarction, ischemic stroke, acute lower extremity ischemia, major amputation due to vascular disease, and emergency arterial revascularization) in subjects aged ≥ 18 years with established atherosclerotic cardiovascular disease (ASCVD), or in men aged ≥ 50 years and women aged ≥ 55 years with a high risk of first ASCVD event.

Test Drug

AZD0780

Active Ingredient

AZD0780

Dosage Form

Tablets

Dosage

30 mg

Endpoints

Time elapsed before any MACE-PLUS component event first occurs

Inclution Criteria

Only participants meeting all of the following criteria are eligible to participate in this trial:
Subject Type and Disease Characteristics

1. Meeting one of the following criteria:

(a) Participants with a history of atherosclerotic cardiovascular disease (ASCVD) events: Participants must be ≥ 18 years old at the time of signing the Initiated Consent Form (ICF), have a history of ASCVD defined as acute coronary syndrome (ACS) 1 to 12 months prior to randomization, or suspected large artery ischemic stroke due to atherosclerotic vascular disease 1 to 12 months prior to randomization, or have undergone revascularization for symptomatic peripheral artery disease (PAD), and have low-density lipoprotein cholesterol (LDL-C) ≥ 60 mg/dL (≥ 1.55 mmol/L).

Additional risk factors based on LDL-C values ​​at screening:

* Subjects with LDL-C ≥ 60 mg/dL (≥ 1.55 mmol/L) and < 75 mg/dL (< 1.9 mmol/L) must also have lipoprotein (a) [Lp(a)] ≥ 25 mg/dL (≥ 60 nmol/L) and at least one other additional risk factor (i to vii).

* Subjects with LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) must also have at least one of the following additional risk factors (i to viii).

i) Type 2 diabetes mellitus (T2DM) requiring continuous medical treatment

ii) Age ≥ 65 years

iii) Symptomatic ASCVD in at least two vascular beds (e.g., coronary artery disease, cerebrovascular disease, or PAD)

iv) History of recurrent ASCVD events (e.g., multiple ACS, ischemic stroke, PAD events, or comorbid events)

v) Previous amputation above the ankle due to PAD

vi) Previous diagnosis of non-end-stage chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m2 [CKD-EPI formula; Delgado et al 2022, Inker et al 2021])

vii) High-sensitivity C-reactive protein (hs-CRP) ≥ 2.0 mg/L, but asymptomatic and without other cause (e.g., infection)

viii) Lp(a) ≥ 25 mg/dL (≥ 60 nmol/L)

(b) Subjects at high risk of first ASCVD event: Male subjects aged ≥ 50 years or female subjects aged ≥ 55 years at the time of ICF signing, 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) Clinically significant atherosclerotic arterial disease meeting any of the following criteria:

a) Coronary artery calcification (CAC) score ≥ 300

b) Underwent percutaneous revascularization for atherosclerosis at any time prior to screening

c) Underwent coronary artery bypass surgery > 5 years prior to screening

d) Ankle-brachial index (ABI) ≤ 0.85

e) ≥ 2 coronary artery regions or ≥ 2 ≥50% stenosis in one vascular bed (coronary arteries, carotid arteries, lower extremities).

ii) High-risk type 1 or type 2 diabetes with manifestations of terminal organ disease (diabetic nephropathy, retinopathy, neuropathy, or ABI exceeding the normal range [0.9 to 1.4]).

iii) Documented, clinically minor atherosclerosis: CAC score of 100 to <300 or not meeting the criteria in section i) above. iv) Subjects meeting criteria ii) and iii) must possess at least one of the following additional risk factors (a to f):

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

c) Age ≥ 65 years

d) T2DM (if meeting clinically mild atherosclerosis criteria iii)

e) Lp(a) ≥ 125 nmol/L

f) hs-CRP ≥ 2.0 mg/L

2. Subjects should receive the maximum tolerated dose of lipid-lowering therapy, including the maximum tolerated dose of statins.

(a) Subjects deemed intolerant of high-intensity statins by their attending physician (typically atorvastatin ≥ 40 mg once daily or rosuvastatin ≥ 20 mg once daily, as per guidelines) may be included if they are receiving low- or moderate-intensity statin therapy.

(b) Subjects not currently receiving any statins must have documented adverse reactions to at least two different statins, including at the lowest standard dose of one, or be using a long-term medication that would preclude the use of statins (based on the relevant statin's prescribing information).

(c) Subjects' lipid-lowering therapy must have reached a stable dose (> 28 days) prior to screening.

Sex and Contraception/Barrier Method Requirements

3. Male and/or female as designated at birth, including all gender identities.

4. Fertility-prone female participants who have sexual intercourse with unsterilized male partners must use an established highly effective method of contraception from the start of screening until the end of the trial, and should continue using a highly effective method for at least 10 days after the last dose of trial treatment. A highly effective method of contraception is defined as one with a failure rate of <1% per year when used consistently and correctly. Such methods include:

- Systemic hormonal contraceptives associated with ovulation suppression (oral/percutaneous/injectable/implantable/vaginal)

- Intrauterine devices/intrauterine hormone-releasing systems

- Bilateral tubal ligation/partner vasectomy. Complete abstinence is an acceptable method, provided it is the participant's usual lifestyle (defined as avoiding sexual intercourse with the opposite sex throughout the trial treatment-related risk period).

Unacceptable methods of contraception include periodic abstinence (e.g., rhythm method, ovulation method, sympathobasic temperature method, post-ovulation method), withdrawal (coitus interruptus), spermicide-only methods, and lactational amenorrhea.

5. Infertile female subjects are defined as women who have undergone permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or are postmenopausal. A woman is considered postmenopausal if she has not menstruated for 12 months or longer after stopping exogenous hormone therapy. Postmenopausal status may also be confirmed using high FSH concentrations within the postmenopausal range, depending on the specific analytical method used. At least two FSH concentrations (at least 4 weeks apart) should be within the postmenopausal range. If hormone replacement therapy (HRT) is discontinued, the first of two consecutive FSH concentration measurements should be performed at least 6 weeks after HRT discontinuation.

Informed Consent
6. Able to provide signed subject consent forms (as described in Appendix A), including compliance with the requirements and limitations set forth in the ICF and this program.

7. Subjects must provide informed consent before commencing any trial-related procedures and agree to comply with all necessary trial procedures.

Exclusion Criteria

Participants must meet any of the following criteria to be eligible for the trial:
Medical Conditions
1. Having any underlying known disease or condition within the 12 months prior to randomization, including homozygous familial hypercholesterolemia, or having undergone low-density lipoprotein (LDL) or plasmapheresis, which the trial administrator deems may interfere with the interpretation of clinical trial results.
2. Planning to undergo any revascularization surgery within the next 3 months.
3. Having a coronary artery calcification score of zero or a coronary computed tomography angiography showing no atherosclerosis within the past 3 years.
4. An eGFR calculated at screening time < 15 mL/min/1.73 m2 (CKD-EPI formula; Delgado et al 2022, Inker et al 2021). 5. Poorly controlled severe hypertension: Despite receiving antihypertensive therapy, systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg (based on the average of 3 consecutive readings) measured at any screening/rescreening follow-up or randomization.

6. Concomitant severe non-cardiovascular (CV) disease with an estimated life expectancy of <2 years.

7. History of malignancy (excluding non-melanoma skin cancer and cervical carcinoma in situ) within the past 5 years.

8. Any laboratory values ​​showing any of the following deviations at screening:

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × Upper Limit of Normal (ULN)

- Total bilirubin (TBL) > 2 × ULN (except for subjects with Gilbert's syndrome, whose direct bilirubin < 1.5 × ULN, in which case TBL of 3 × ULN is acceptable)

- Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)

- Creatine kinase > 5 × ULN

- Urine albumin/creatinine ratio ≥ 500 mg/g

9. Currently pregnant (confirmed pregnancy test) or breastfeeding.

10. Known history of alcohol and/or drug abuse within the past 5 years.

11. Receiving any major organ transplant, such as lung, liver, heart, bone marrow, or kidney.

12. An acute ischemic ASCVD event occurred within 7 days prior to screening.

13. A QT interval (QTcF) corrected to the Fredericia formula at the time of randomization > 470 ms, or a family history of long QT syndrome.

14. High-degree atrioventricular (AV) block II-III or sinoatrial node dysfunction with clinically significant sinus arrest, and not treated with a pacemaker.

15. New York Heart Association (NYHA) Class IV heart failure.

16. Ventricular arrhythmias requiring treatment.

17. A prior diagnosis of hypertrophic obstructive cardiomyopathy, or any infiltrative cardiomyopathy, such as sarcomatoid disease or amyloidosis.

18. A history of allergy to chemically similar drugs.

19. Any poorly controlled or serious illness, or any medical condition (e.g., known major active infection [e.g., hepatitis B and C] or major CV, hematological, renal, metabolic, gastrointestinal, respiratory, hepatic, or endocrine dysfunction) or surgical condition that the trial administrator deems likely to interfere with the subject's participation in the clinical trial and/or expose the subject to significant risk.

20. Poorly controlled type 2 diabetes mellitus (T2DM), defined as HbA1c ≥ 9.5% at screening.

21. Untreated hypothyroidism, defined as thyroid-stimulating hormone (TSH) > 1.5 × upper limit of normal (ULN) at screening, or subjects who have started or adjusted thyroid replacement therapy within 3 months prior to screening.

Previous or planned concomitant therapies

22. Currently using, or having previously used, medications with a black box warning indicating significant QT interval prolongation within 14 days prior to screening.

23. Use of mipomersen or lomitapide (cholesterol-lowering drugs) within 12 months prior to screening or planned during the trial.

24. Use of gemfibrozil within 1 week prior to screening follow-up or planned during the trial.

25. Use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors: Use of evolocumab/alirocumab within 12 weeks prior to screening follow-up or planned during the trial, or use of inclisiran within 18 months prior to screening follow-up or planned during the trial, or use of any other approved PCSK9 inhibitor within 5 half-lives prior to screening follow-up or planned during the trial.

Previous/Concurrent Clinical Trial Experience

26. Participation in another clinical trial using an investigational drug (IMP) or device within 30 days or 5 half-lives (whichever is longer) prior to screening follow-up.

27. Planned use of other investigational drugs or devices during the trial. Other Exclusion Criteria

28 Any situation deemed by the trial administrator to be potentially interfering with the trial execution, such as:

- Inability to communicate or cooperate with the trial administrator.

- Inability to understand or is unlikely to comply with the trial plan requirements, instructions, trial-related limitations, and the nature, scope, and potential consequences of the trial.

29 Participation in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center personnel).

30 Previously randomly assigned to this trial.

The Estimated Number of Participants

  • Taiwan

    440 participants

  • Global

    15100 participants

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