Health TrialsbyHealthPanel

Feasibility of Combination Therapy With Low-dose Statin and Ezetimibe in Patients With Minimal Subclinical Atherosclerosis

ConditionAtherosclerosis Cardiovascular Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-79
SponsorYonsei University

About this trial

This study aims to compare the tolerability and metabolic safety of three low-dose statin/ezetimibe combinations (rosuvastatin/ezetimibe 2.5/10 mg, atorvastatin/ezetimibe 5/10 mg, pitavastatin/ezetimibe 1/10 mg) in patients with minimal subclinical atherosclerosis identified by imaging studies (CCTA, CAG, or carotid sonography)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women between the ages of 30 and 80

Minimal subclinical coronary artery disease with less than 30% coronary artery stenosis on CCTA or CAG

Individuals with a coronary artery calcification index (CACS/CCS) between 0 and less than 100

Patients with carotid plaque detected on carotid ultrasound (diameter stenosis less than 30%) or intima-media thickness (IMT) of 1.5 mm or more, or a protrusion of 0.5 mm or more

Disqualifiers

Individuals diagnosed with existing diabetes (Type 1 or Type 2 DM): HbA1c ≥ 6.5% or those taking diabetes medications (oral hypoglycemic agents or insulin)

Individuals with a coronary artery calcification index (CACS) of 100 or higher

Individuals with coronary artery stenosis of 30% or more on a CCTA or CAG

Individuals whose LDL-C levels are below the initiation criteria based on the number of major cardiovascular risk factors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Crezet 2.5/10mg

    Drug

    Participants will take 1 tablet of Rosuvastatin/ezetimibe 2.5/10mg(Crezet 2.5/10mg) orally once daily for 12 months

  • Litorvazet 5/10mg

    Drug

    Participants will take 1 tablet of Atorvastatin/ezetimibe 5/10mg (Litorvazet 5/10mg) orally once daily for 12 months

  • Baroezet 1/10mg

    Drug

    Participants will take 1 tablet of Pitavastatin/ezetimibe 1/10mg (Baroezet 1/10mg) orally once daily for 12 months

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Rosuvastatin/ezetimibe 2.5/10mgExperimental treatment 1 intervention
Group B: Atorvastatin/ezetimibe 5/10mgExperimental treatment 1 intervention
Group C: Pitavastatin/ezetimibe 1/10mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

discontinuation or drug change of the study drug due to intolerance

Incidence rate of "discontinuation or drug change of the study drug due to intolerance" up to one year in time

Time frame
Verified for 1 year after registration

Secondary outcomes

1

New-Onset Diabetes Mellitus (NODM)

New-Onset Diabetes Mellitus (NODM): Defined as HbA1c ≥ 6.5% (FPG ≥ 126 mg/dL is excluded from the diagnostic criteria)

Time frame
Verified for 1 year after registration
2

HbA1c

12-month change in HbA1c compared to baseline

Time frame
Check after 12 months of registration
3

LDL-C target achievement rate

LDL-C target achievement rate (target achievement rate: LDL-C \< 100 mg/dL Criteria)

Time frame
Check after 12 months of registration
4

LDL-C levels

LDL-C levels for 12 months

Time frame
Check after 12 months of registration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: