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New treatment option for Primary Prevention
Official title GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification
ClinicalTrials.gov ID: NCT06722521
What this study is testing
What is Pitavastatin 4mg and ezetimibe 10mg, taken once daily?
Pitavastatin 4mg and ezetimibe 10mg, taken once daily is an investigational medicine, being studied as a potential treatment for primary prevention.
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
- A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification
- 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 19 and older
You may be able to join if
- Adults aged 19 years and older
- Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)
- The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.
- The assessment of physiological significance must be performed within 6 months prior to randomization
- Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.
You likely can't join if
- Major ASCVD events (clinically documented ASCVD) If at least one of the following criteria is present via patient history, physical examination, or...
- Acute coronary syndrome (MI or unstable angina)
- Coronary revascularization (PCI, CABG) or other arterial revascularization
- Ischemic stroke (Not TIA)
- Symptomatic peripheral arterial disease (history of claudication with ABI \<0.90, or previous revascularization or amputation
- Patients with physiologically significant CAD
See the full eligibility criteria
- Adults aged 19 years and older
- Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)
- The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.
- The assessment of physiological significance must be performed within 6 months prior to randomization
- Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.
- Major ASCVD events (clinically documented ASCVD) If at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening, the patient is not eligible:
- Acute coronary syndrome (MI or unstable angina)
- Coronary revascularization (PCI, CABG) or other arterial revascularization
- Ischemic stroke (Not TIA)
- Symptomatic peripheral arterial disease (history of claudication with ABI \<0.90, or previous revascularization or amputation
- Patients with physiologically significant CAD
- Moderate to severe CAD (diameter stenosis \>50%) on CCTA with positive strest test (thallium, treadmil, stress echocardiography)
- Moderate to severe CAD (diameter stenosis \>50%) on CAG with positive fractional flow reserve (FFR) \< 0.8
- Patients with familial hypercholesterolemia.
- Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg/dL regardless taking a statin or not.
- Continuation of PCSK9 inhibitor is required during the clinical trial
- Patients with chronic kidney disease (\<eGFR 30mL/min/1.73m2)
- Advanced liver disease (Child-Pugh B or C)
- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 5 times upper limit of normal).
- History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months prior screening
- Patients with a history of organ transplantation who are on immunosuppressive therapy
- Concurrent use of other medications that may increase bleeding risk such NOAC and warfarin
- A history of significant allergic reaction to aspirin or statin/ezetimibe
- 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.
- Life expectancy \< 1 years for any non-cardiac or cardiac causes.
- Patient's pregnant or breast-feeding or child-bearing potential.
- 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...
- Unwillingness or inability to comply with the procedures described in this protocol
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, 19 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.