Ireland
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Enrolling by invitation Phase 4

Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)

NCT05579626 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2023-03-14
Last updated
2026-01-07

Condition(s) studied

Pre DiabetesASCVD

Investigational drug(s) / intervention(s)

high-intensity statin armlow-intensity statin plus ezetimibeAll Low intensity statin trials (2) →All Ezetimibe trials (15) →

high-intensity statin arm: •high-intensity statin strategy (standard arm): rosuvastatin 20 mg PO qd, once daily

low-intensity statin plus ezetimibe: •low-intensity statin plus ezetimibe strategy (experimental arm): rosuvastatin 5mg /ezetimibe 10mg PO qd), once daily

Study summary

This study is to evaluating the impact of low-intensity statin plus ezetimibe versus high-intensity statin therapy on risk of new-onset diabetes mellitus in patients with atherosclerotic cardiovascular disease who have prediabetes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men or women between the ages of 18 and 75 years who have prediabetes \- Prediabetes consists of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or HbA1c 1. IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL 2. IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL 3. HbA1c: 5.7 to 6.4% 2. Patient requiring high-intensity statin due to high risk of a future cardiovascular event if at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening (Clinically documented ASCVD) * acute coronary syndrome (MI or unstable angina) * stable angina * coronary revascularization (PCI, CABG, and other arterial revascularization procedure) * stroke or TIA * peripheral arterial disease (\<0.9 performed by a vascular lab or angiogram (including CTA) showing ≥ 50%) * ThoracoAbdominal Aortic Aneurysm * Unequivocally documented ASCVD on imaging * significant plaque on coronary angiography on CT (mild, moderate, severe coronary artery disease) * significant plaque on carotid ultrasound (mild, moderate, severe carotid disease) 3. Patients who have never taken a statin or who do not have problems adhering to statin therapy 4. Patient must have been on a stable diet prior to randomization and willing to follow the NCEP (national Cholesterol Education Program) TLC (therapeutic lifestyle changes) diet, or equivalent diet, throughout the study. 5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: 1. Patient's pregnant or breast-feeding or child-bearing potential. 2. Concomitant administration of potent inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins). 3. Chronic kidney disease (eGFR\<30 ml/min/1.73m2) or dialysis-dependent renal failure 4. Uncontrolled hypothyroidism. 5. Personal or family history of hereditary muscular disorders. 6. History of muscular toxicity with a statin 7. Alcoholism. 8. Hypersensitivity to any of statin and ezetimibe. 9. Hemodynamic unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV). 10. Any history of hemorrhagic stroke or intracranial hemorrhage within the past 6 months 11. Any surgery requiring discontinuation of statin and/or ezetimibe is planned within 6 months after randomization 12. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. 13. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. 14. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal) or (Total bilirubin\> 2 times upper limit of normal). 15. Life expectancy \< 1 years for any non-cardiac or cardiac causes 16. Unwillingness or inability to comply with the procedures described in this protocol. 17. People who have previously been diagnosed with diabetes and are taking lifestyle modification and oral hypoglycemic agent (OHA) or insulin (In woman, gestational diabetes is included)

Primary outcome measure(s)

  • Number of Participants with New-onset-DM — 36months after randomization
    New onset DM was defined on the the basis of the American Diabetes association guideline if two abnormal test results of following criteria are existed from the same sample or in two separate test samples. 1. fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours OR 2. 2 hour plasma glucose during a 75 g oral glucose tolerance test (OGTT) ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR 3. HbA1C ≥6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP (National Glycohemoglobin Standardization Program) certified and standardized to the DCCT (Diabetes Control and Complication Trial) assay.
  • Number of Participants with death — 36months after randomization
    Major adverse cardiac events are defined as all-cause death

Trial sites (31)

FacilityCityRegionStatus
Bycheon Sejong Hospital Bucheon-si South Korea
Gyeongsang National University Changwon Hospital Changwon South Korea
Chungbuk National University Hospital Cheonju South Korea
Gangwon National University Hospital Chuncheon South Korea
Daegu Catholic University Medical Center Daegu South Korea
Keimyung University Dongsan Medical Center Daegu South Korea
Yungnam universury Hospital Daegu South Korea
Chungnam National University Sejong Hospital Daejeon South Korea
Konyang University Hospital Daejeon South Korea
the Catholic University of Korea, Daejeon St. Mary'S Hospital Daejeon South Korea
Gangneung Asan Hospital Gangneung South Korea
Chonnam National University Hospital Gwangju South Korea
Inje University Haeundae Paik Hospital Haeundae South Korea
Hallym University Dongtan Sacred Heart Hospital Hwaseong-si South Korea
Gachon University Gil Medical Center Incheon South Korea
Jeju National University Hospital Jeju City South Korea
Gyeongsang National University Hospital Jinju South Korea
Chungnam National University Hospital Jungnam South Korea
Dong-A Medical Center Pusan South Korea
Inje University Busan Paik Hospital Pusan South Korea
Kosin University Gospel Hospital Pusan South Korea
Pusan National University Yangsan Hospital Pusan South Korea
Asan Medical Center Seoul South Korea
Catholic University of Korea, Seoul ST. Mary's Hospital. Seoul South Korea
Ewha womans university seoul hospital Seoul South Korea
Kangdong Sacred Heart Hospital Seoul South Korea
Korea University Anam Hospital Seoul South Korea
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital Seoul South Korea
VHS Medical Center Seoul South Korea
The Catholic University of Korea, St. Vincent's Hospital Suwon South Korea
Ulsan university hospital Ulsan South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05579626 on ClinicalTrials.gov ↗ ← All trials in South Korea