Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)
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- STATUS
- Recruiting
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- End date
- Dec 30, 2027
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- participants needed
- 4000
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- sponsor
- Seung-Whan Lee, M.D., Ph.D.
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.
Description
The PROVE-DM trial is a multi-center, open-labeled, randomized controlled trial comparing two different lipid lowering strategies in patients with prediabetes and established atherosclerosis. Patients with prediabetes and documented atherosclerosis, either clinical or unequivocal on imaging are eligible for enrollment. The detailed information for inclusion and exclusion criteria is described below in the session 4. Patients meeting inclusion criteria without any exclusion criteria are assessed to be able to tolerate high-intensity statin therapy while achieving the target LDL level (LDL cholesterol < 70 mg/dL for established atherosclerotic cardiovascular disease or LDL cholesterol < 100 mg/dL for mild to moderate coronary artery disease) through a run-in period of 2 to 6 months. (Run in period was set as a screening process to reduce drop-out cases that cannot withstand high-intensity statins or cannot accomplished target LDL levels) Eligible patients will be randomized to high-intensity statin (rosuvastatin 20 mg qd) or low-intensity statin plus ezetimibe (rosuvastatin 5/10mg/ ezetimibe 10 mg qd). Patients will be followed-up clinically at 6, 12 months and then annually up to 3 years after randomization. Follow-up measurement of DM diagnostic criteria (fasting plasma glucose, plasma Hb A1c, oral glucose tolerance test) and lipid profile is intended to 1) provide evidence of new onset DM, 2) evaluate effectiveness of lowering LDL cholesterol. To ensure the accurate assessment of the clinical outcomes, cardiovascular safety end point (death from cardiovascular causes, non-fatal myocardial infarction, or non-fatal stroke), any arterial revascularization, any potential side effects of statin and all-cause mortality were also investigated.
Details
| Condition | Pre Diabetes, ASCVD |
|---|---|
| Treatment | high-intensity statin arm, low-intensity statin plus ezetimibe |
| Clinical Study Identifier | NCT05579626 |
| Sponsor | Seung-Whan Lee, M.D., Ph.D. |
| Last Modified on | 9 April 2023 |
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