Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSaint Vincent's Hospital, Korea

About this trial

\[Purpose of the Clinical Study\]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease without percutaneous coronary intervention to confirm non-inferiority in the reduction of key cardiovascular events.

\[Hypothesis\]:In patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease, low-dose rosuvastatin and ezetimibe combination therapy are non-inferior in terms of reducing major cardiovascular events compared to high-dose rosuvastatin monotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female adjusts (19 or older)

Patients with suspected stable angina pectoris without coronary artery interventions, who showed a minimal to intermediate coronary artery diseases (a stenosis of 10 to 70% diameter as per QCA) in at least one natural coronary artery in coronary artery angiography or coronary artery CT.

Patients who gave their informed consent themselves in writing.

Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines.

Disqualifiers

Patients with an intermediate (>30%) lesion on the left main coronary artery.

Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)

Patients who received percutaneous coronary intervention

Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg

    Drug

    Oral administration once a day, taking it for 3 years

  • Mono drug group of Rosuvastatin 20 mg

    Drug

    Oral administration once a day, taking it for 3 years

Treatment groups

6,356 Participants
are divided into 2 treatment groups
Group A: Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mgExperimental treatment 1 intervention
Group B: Mono drug group of Rosuvastatin 20 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The occurrence rates of the compound variables

The occurrence rates of the compound variables of all cause deaths, cardiac deaths, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, and revascularization after taking the study medicine at the time of Visit 5 (36 month) were compared between groups

Time frame
Visit 5 (36month)

Secondary outcomes

Other outcomes

Sponsors and contacts

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