Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Seung-Whan Lee, M.D., Ph.D. trials in South Korea
Other trials for the same condition
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