ASCVDPhase 4NCT06767774

Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus

A Phase 4 study testing Combination therapy and High intensity statin monotherapy in people with ASCVD and Diabetes, run by Korea University Anam Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: ASCVD, Diabetes, Statin
What is being tested?: Combination therapy and High intensity statin monotherapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 1 siteSouth Korea
Study dates: 25 Apr 2025to 31 Jan 2030
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age Requirement:
Patients aged 18 years or older.
Glycemic Status:
Patients who are not taking oral hypoglycemic agents (OHAs) and meet all of the following criteria:
Fasting glucose less than 126 mg/dL.*
HbA1c less than 6.5%.

Show all 27Show fewer

Plasma glucose less than 200 mg/dL after 2 hours during a 75 g oral glucose tolerance test (OGTT).*Note: For fasting glucose, two measurements of 126 mg/dL or greater within 3 months are required for a diagnosis of diabetes.
Cardiovascular Disease:
Patients with established atherosclerotic cardiovascular disease, defined as having at least one of the following:
Coronary Heart Disease (CHD):
Documented history of myocardial infarction (MI).
History of coronary revascularization.
50% stenosis of a major epicardial coronary artery confirmed by cardiac catheterization, computed tomography (CT), or coronary angiography.
Cerebrovascular Disease:
>History of stroke of atherosclerotic origin.
History of carotid revascularization.
>≥50% stenosis of the carotid artery confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound.
Symptomatic Peripheral Arterial Disease (PAD):
>Intermittent claudication with an ankle-brachial index (ABI) of 0.90 at rest.
Intermittent claudication with ≥50% stenosis of a peripheral artery (excluding the carotid artery) confirmed by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound.
History of revascularization of peripheral arteries (excluding carotid arteries).
Lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding trauma or osteomyelitis).
Dietary Requirements:
Patients must be on a stable diet prior to randomization and able to adhere to the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Change (TLC) diet or an equivalent throughout the study.
Informed Consent:
Subjects or their legal representatives must provide written informed consent to the study protocol and clinical follow-up schedule.
An informed consent form approved by the institutional review board (IRB)/ethics committee of the study site must be signed.

Who cannot join

Patient is pregnant or breastfeeding or of childbearing potential.
Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).
Chronic kidney disease (eGFR < 30 ml/min/1.73m²) or dialysis-dependent renal failure.
Uncontrolled hypothyroidism.
Personal or family history of an inherited muscle disorder.
History of statin-induced muscle toxicity.

Show all 17Show fewer

Alcohol-dependent person.
Hypersensitivity to statins and ezetimibe.
Hemodynamic instability at the time of enrollment: cardiogenic shock, refractory ventricular arrhythmia, or congestive heart failure (New York Heart Association class IV) at randomization.
History of hemorrhagic stroke or intracranial hemorrhage, TIA, or ischemic stroke within the past 6 months.
Planned surgery requiring discontinuation of statins or ezetimibe within 6 months of randomization.
Current treatment for active cancer.
Clinically significant abnormal findings identified at the screening visit, physical examination, laboratory tests, or electrocardiogram that, in the investigator's judgment, may interfere with safe completion of the study.
Liver disease or biliary obstruction, elevated liver enzymes (ALT or AST > the upper limit of normal) or elevated total bilirubin (total bilirubin > 2 times the upper limit of normal) at screening.
Life expectancy for noncardiac or cardiac causes < 1 year.
Unwillingness or inability to comply with the procedures described in this protocol.
Previously diagnosed with diabetes mellitus and compliant with lifestyle modification and taking oral hypoglycemic agents (OHAs) or insulin.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cheol Woong Yu contact

+82-2-920-5445

ycw717@naver.com

South Korea1 site, 1 recruiting

Korea University Anam Hospital
Seoul, 02841
Korea Hospital
Recruiting

Other trials in South Korea

About this study

Official title: Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease

The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg). Enrolling 2,000 non-diabetic participants with ASCVD, subjects are randomized 1:1 into the two treatment arms. The primary outcome is the incidence of new-onset DM over a follow-up period of up to 36 months. Secondary outcomes include cardiovascular events, changes in LDL cholesterol, fasting glucose, HbA1c, and insulin resistance. This trial hypothesizes that the combination therapy will achieve LDL targets with a lower risk of new-onset DM compared to high-intensity statin monotherapy.

Conditions: ASCVD, Diabetes, Statin
Being tested: Combination therapy, High intensity statin monotherapy
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination therapyDrug
- pitavastatin 4mg
- ezetimibe 10mg
High intensity statin monotherapyDrug
rosuvastatin 20mg

Study groups in NCT06767774
Study group	Role	What they receive
Combination therapy	Experimental	fixed dose single-pill combination of pitavastatin 4mg plus ezetimibe 10mg Receives: Drug: Combination therapy
High intensity statin monotherapy	Active comparator	Rosuvastatin 20mg Receives: Drug: High intensity statin monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

new-onset diabetes mellitus meeting diagnostic criteria for conventional diabetes during the treatment period
Measured: 3 years

Secondary outcomes (1)

1. Composite of major clinical events of cardiovascular disease (death from cardiovascular disease, nonfatal myocardial infarction or nonfatal stroke)
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202531 Jan 2030

First posted10 Jan 2025
Study start25 Apr 2025
Primary completion31 Aug 2029 (estimated)
Study completion31 Jan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for ASCVDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06767774
Sponsor's protocol ID: AVOIDM
Status last verified: Apr 2025
First submitted: 5 Jan 2025
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The corresponding author had full access to all the data in the study and takes responsibility for its integrity and the data analysis. The data are available upon reasonable request.

Publications

Mach F, Ray KK, Wiklund O, Corsini A, Catapano AL, Bruckert E, De Backer G, Hegele RA, Hovingh GK, Jacobson TA, Krauss RM, Laufs U, Leiter LA, Marz W, Nordestgaard BG, Raal FJ, Roden M, Santos RD, Stein EA, Stroes ES, Thompson PD, Tokgozoglu L, Vladutiu GD, Gencer B, Stock JK, Ginsberg HN, Chapman MJ; European Atherosclerosis Society Consensus Panel. Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract. Eur Heart J. 2018 Jul 14;39(27):2526-2539. doi: 10.1093/eurheartj/ehy182.
PubMed 29718253
Lakatos E. Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics. 1988 Mar;44(1):229-41.
PubMed 3358991
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
PubMed 24239923
Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C; American College of Cardiology; American Heart Association; National Heart, Lung and Blood Institute. ACC/AHA/NHLBI Clinical Advisory on the Use and Safety of Statins. Circulation. 2002 Aug 20;106(8):1024-8. doi: 10.1161/01.cir.0000032466.44170.44. No abstract available.
PubMed 12186811
American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
PubMed 30559228
Wilson PWF, Polonsky TS, Miedema MD, Khera A, Kosinski AS, Kuvin JT. Systematic Review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1144-e1161. doi: 10.1161/CIR.0000000000000626. Epub 2018 Nov 10.
PubMed 30586775
Giugliano RP, Cannon CP, Blazing MA, Nicolau JC, Corbalan R, Spinar J, Park JG, White JA, Bohula EA, Braunwald E; IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) Investigators. Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). Circulation. 2018 Apr 10;137(15):1571-1582. doi: 10.1161/CIRCULATIONAHA.117.030950. Epub 2017 Dec 20.
PubMed 29263150
Morrone D, Weintraub WS, Toth PP, Hanson ME, Lowe RS, Lin J, Shah AK, Tershakovec AM. Lipid-altering efficacy of ezetimibe plus statin and statin monotherapy and identification of factors associated with treatment response: a pooled analysis of over 21,000 subjects from 27 clinical trials. Atherosclerosis. 2012 Aug;223(2):251-61. doi: 10.1016/j.atherosclerosis.2012.02.016. Epub 2012 Feb 16.
PubMed 22410123
Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657
Hu FB, Stampfer MJ, Haffner SM, Solomon CG, Willett WC, Manson JE. Elevated risk of cardiovascular disease prior to clinical diagnosis of type 2 diabetes. Diabetes Care. 2002 Jul;25(7):1129-34. doi: 10.2337/diacare.25.7.1129.
PubMed 12087009
Gerstein HC, Santaguida P, Raina P, Morrison KM, Balion C, Hunt D, Yazdi H, Booker L. Annual incidence and relative risk of diabetes in people with various categories of dysglycemia: a systematic overview and meta-analysis of prospective studies. Diabetes Res Clin Pract. 2007 Dec;78(3):305-12. doi: 10.1016/j.diabres.2007.05.004. Epub 2007 Jun 29.
PubMed 17601626
Yip WCY, Sequeira IR, Plank LD, Poppitt SD. Prevalence of Pre-Diabetes across Ethnicities: A Review of Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) for Classification of Dysglycaemia. Nutrients. 2017 Nov 22;9(11):1273. doi: 10.3390/nu9111273.
PubMed 29165385
Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events. A metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care. 1999 Feb;22(2):233-40. doi: 10.2337/diacare.22.2.233.
PubMed 10333939
Rhee EJ, Kim HC, Kim JH, Lee EY, Kim BJ, Kim EM, Song Y, Lim JH, Kim HJ, Choi S, Moon MK, Na JO, Park KY, Oh MS, Han SY, Noh J, Yi KH, Lee SH, Hong SC, Jeong IK; Committee of Clinical Practice Guideline of Korean Society of Lipid and Atherosclerosis. 2018 Guidelines for the management of dyslipidemia in Korea. Korean J Intern Med. 2019 Sep;34(5):1171. doi: 10.3904/kjim.2019.188.e1. Epub 2019 Aug 28. No abstract available.
PubMed 31466435

Interested in taking part?

Cheol Woong Yu

+82-2-920-5445

ycw717@naver.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease
ClinicalTrials.gov ID: NCT06767774
Acronym / sponsor ID: AVOIDM
Conditions: ASCVD, Diabetes, Statin
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 2,000 participants (estimated)
Lead sponsor: Korea University Anam HospitalUniversity, hospital or other
Collaborators: Daewon Pharmaceutical Co., Ltd., Samjin Pharmaceutical Co., Ltd.
Study start: 25 Apr 2025 (actual)
Primary completion: 31 Aug 2029 (estimated)
Study completion: 31 Jan 2030 (estimated)
First posted: 10 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Combination therapy	Experimental	Drug: Combination therapyfixed dose single-pill combination of pitavastatin 4mg plus ezetimibe 10mg
High intensity statin monotherapy	Active comparator	Drug: High intensity statin monotherapyRosuvastatin 20mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Age Requirement:
Patients who are not taking oral hypoglycemic agents (OHAs) and meet all of the following criteria:
Patients with established atherosclerotic cardiovascular disease, defined as having at least one of the following:
>History of stroke of atherosclerotic origin.
>≥50% stenosis of the carotid artery confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound.

Key exclusion criteria (17 listed)

Patient is pregnant or breastfeeding or of childbearing potential.
Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).
Chronic kidney disease (eGFR < 30 ml/min/1.73m²) or dialysis-dependent renal failure.
Uncontrolled hypothyroidism.
Personal or family history of an inherited muscle disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Combination therapy* pitavastatin 4mg * ezetimibe 10mg	Drug	Combination therapy
High intensity statin monotherapyrosuvastatin 20mg	Drug	High intensity statin monotherapy

Primary outcome

new-onset diabetes mellitus meeting diagnostic criteria for conventional diabetes during the treatment period
Time frame: 3 years

1 secondary outcome

1. Composite of major clinical events of cardiovascular disease (death from cardiovascular disease, nonfatal myocardial infarction or nonfatal stroke)
Time frame: 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Results publication: PubMed 29718253Mach F, Ray KK, Wiklund O, Corsini A, Catapano AL, Bruckert E, De Backer G, Hegele RA, Hovingh GK, Jacobson TA, Krauss RM, Laufs U, Leiter LA, Marz W, Nordestgaard BG, Raal FJ, Roden M, Santos RD, Stein EA, Stroes ES, Thompson PD, Tokgozoglu L, Vladutiu GD, Gencer B, Stock JK, Ginsberg HN, Chapman MJ; European Atherosclerosis Society Consensus Panel. Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract. Eur Heart J. 2018 Jul 14;39(27):2526-2539. doi: 10.1093/eurheartj/ehy182.
Results publication: PubMed 3358991Lakatos E. Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics. 1988 Mar;44(1):229-41.
Results publication: PubMed 24239923Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
Results publication: PubMed 12186811Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C; American College of Cardiology; American Heart Association; National Heart, Lung and Blood Institute. ACC/AHA/NHLBI Clinical Advisory on the Use and Safety of Statins. Circulation. 2002 Aug 20;106(8):1024-8. doi: 10.1161/01.cir.0000032466.44170.44. No abstract available.
Results publication: PubMed 30559228American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
Results publication: PubMed 30586775Wilson PWF, Polonsky TS, Miedema MD, Khera A, Kosinski AS, Kuvin JT. Systematic Review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1144-e1161. doi: 10.1161/CIR.0000000000000626. Epub 2018 Nov 10.
Results publication: PubMed 29263150Giugliano RP, Cannon CP, Blazing MA, Nicolau JC, Corbalan R, Spinar J, Park JG, White JA, Bohula EA, Braunwald E; IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) Investigators. Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). Circulation. 2018 Apr 10;137(15):1571-1582. doi: 10.1161/CIRCULATIONAHA.117.030950. Epub 2017 Dec 20.
Results publication: PubMed 22410123Morrone D, Weintraub WS, Toth PP, Hanson ME, Lowe RS, Lin J, Shah AK, Tershakovec AM. Lipid-altering efficacy of ezetimibe plus statin and statin monotherapy and identification of factors associated with treatment response: a pooled analysis of over 21,000 subjects from 27 clinical trials. Atherosclerosis. 2012 Aug;223(2):251-61. doi: 10.1016/j.atherosclerosis.2012.02.016. Epub 2012 Feb 16.
Results publication: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
Results publication: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
Results publication: PubMed 12087009Hu FB, Stampfer MJ, Haffner SM, Solomon CG, Willett WC, Manson JE. Elevated risk of cardiovascular disease prior to clinical diagnosis of type 2 diabetes. Diabetes Care. 2002 Jul;25(7):1129-34. doi: 10.2337/diacare.25.7.1129.
Results publication: PubMed 17601626Gerstein HC, Santaguida P, Raina P, Morrison KM, Balion C, Hunt D, Yazdi H, Booker L. Annual incidence and relative risk of diabetes in people with various categories of dysglycemia: a systematic overview and meta-analysis of prospective studies. Diabetes Res Clin Pract. 2007 Dec;78(3):305-12. doi: 10.1016/j.diabres.2007.05.004. Epub 2007 Jun 29.
Individual participant dataSharing planned: Yes. The corresponding author had full access to all the data in the study and takes responsibility for its integrity and the data analysis. The data are available upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Cheol Woong Yu contact

+82-2-920-5445

ycw717@naver.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combination therapy and High intensity statin monotherapy in people with ASCVD and Diabetes, run by Korea University Anam Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cheol Woong Yu (+82-2-920-5445, ycw717@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

new-onset diabetes mellitus meeting diagnostic criteria for conventional diabetes during the treatment period (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767774, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.