Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus
NCT ID: NCT06767774
Last Updated: 2025-04-27
Study Results
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Basic Information
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RECRUITING
PHASE4
2000 participants
INTERVENTIONAL
2025-04-25
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Combination therapy
fixed dose single-pill combination of pitavastatin 4mg plus ezetimibe 10mg
Combination therapy
* pitavastatin 4mg
* ezetimibe 10mg
High intensity statin monotherapy
Rosuvastatin 20mg
High intensity statin monotherapy
rosuvastatin 20mg
Interventions
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Combination therapy
* pitavastatin 4mg
* ezetimibe 10mg
High intensity statin monotherapy
rosuvastatin 20mg
Eligibility Criteria
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Inclusion Criteria
* 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%.
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Samjin Pharmaceutical Co., Ltd.
INDUSTRY
Korea University Anam Hospital
OTHER
Responsible Party
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Dr. Cheol Woong Yu
Professor
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Korea Hospital
Role: primary
References
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Other Identifiers
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AVOIDM
Identifier Type: -
Identifier Source: org_study_id
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