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 : A Prospective, Multicenter, Randomized, Open-label Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

\[Purpose of the Clinical Study\]: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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
St. Vincent's Hospital
RECRUITING
Suwon
Contact Information
Primary
Sung-ho Her, MD.PhD
hhhsungho@naver.com
821077310052
Backup
Jung Jin, MD
colaking@naver.com
821087238603
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 6356
Treatments
Experimental: Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg
Ezetimibe 10 mg/Rosuvastatin 5 mg, Oral administration once a day, taking it for 3 years
Active_comparator: Mono drug group of Rosuvastatin 20 mg
Rosuvastatin 20 mg , Oral administration once a day, taking it for 3 years
Sponsors
Leads: Saint Vincent's Hospital, Korea

This content was sourced from clinicaltrials.gov

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