KCT0007787招募中未知
Comparison of low - intensity statin plus ezetimibe versus high- intensity statin therapy on risk of new - onset diabetes mellitus in prediabetic patients with atherosclerotic cardiovascular disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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
- •(a) IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL
- •(b) IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL
- •(c) 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%)
- •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 were not given statins (statin naive) or who were no compliance problems.
- •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.
排除标准
- •1. Patient’s pregnant or breast-feeding or child-bearing potential.
- •2. The one who used to take high intensity statins. (40mg or more of atorvastatin, 20mg or more of rosuvastatin)
- •3. 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).
- •4. Chronic kidney disease (eGFR<30 ml/min/1.73m2) or dialysis-dependent renal failure
- •5. Uncontrolled hypothyroidism.
- •6. Personal or family history of hereditary muscular disorders.
- •7. History of muscular toxicity with a statin
- •8. Alcoholism.
- •9. Hypersensitivity to any of statin and ezetimibe.
- •10. 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).
- •11. Any history of hemorrhagic stroke or intracranial hemorrhage within the past 6 months
- •12. Any surgery requiring discontinuation of statin and/or ezetimibe is planned within 6 months after randomization
- •13. 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.
- •14. 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.
- •15. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- •16. Life expectancy < 1 years for any non-cardiac or cardiac causes
- •17. Unwillingness or inability to comply with the procedures described in this protocol.
- •18. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •19. People who have previously been diagnosed with diabetes and are taking lifestyle modification and oral hypoglycemic agent (OHA) or insulin
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