Comparing two cholesterol-lowering treatments for diabetes risk in heart disease patients
Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease
This study is testing whether a combination of two cholesterol-lowering medications can help heart disease patients with prediabetes avoid developing diabetes better than a stronger single medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06767774 on ClinicalTrials.gov |
What this trial studies
The AVOID-DM trial is a multicenter, prospective, randomized study designed to compare the risk of developing new-onset diabetes mellitus between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease. Participants will be randomized into two groups: one receiving a combination of pitavastatin and ezetimibe, and the other receiving high-intensity statin monotherapy with rosuvastatin. The primary outcome will assess the incidence of new-onset diabetes over a follow-up period of up to 36 months, while secondary outcomes will evaluate cardiovascular events and changes in various metabolic parameters. This study aims to determine if the combination therapy can achieve LDL targets with a lower risk of diabetes compared to high-intensity statin therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with established atherosclerotic cardiovascular disease and prediabetes who are not currently on diabetes medications.
Not a fit: Patients who already have diabetes or are taking oral hypoglycemic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify a safer cholesterol-lowering strategy that minimizes the risk of diabetes in patients with heart disease.
How similar studies have performed: Other studies have explored similar cholesterol-lowering strategies, but this specific comparison of pitavastatin plus ezetimibe versus high-intensity statin therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age Requirement:
* 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:
* Patient is pregnant or breastfeeding or of childbearing potential.
* 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.
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Cheol Woong Yu
- Email: ycw717@naver.com
- Phone: +82-2-920-5445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.