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Compares treatment options for ASCVD
Official title Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus
ClinicalTrials.gov ID: NCT06767774
What this study is testing
What is Combination therapy?
Combination therapy is an investigational medicine, being studied as a potential treatment for ascvd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%.
You likely can't join if
- Patient is pregnant or breastfeeding or of childbearing potential.
- Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin...
- 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.
See the full eligibility 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...
- 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...
- people 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.