NCT06186037 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
| NCT ID | NCT06186037 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Saint Vincent's Hospital, Korea |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,356 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 6,356 participants in total. It began in 2024-02-01 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Male and female adjusts (19 or older) 2. 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. 3. Patients who gave their informed consent themselves in writing. 4. Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines. Exclusion Criteria: 1. Patients with an intermediate (\>30%) lesion on the left main coronary artery. 2. Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina) 3. Patients who received percutaneous coronary intervention 4. Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases. 5. Patients diagnosed with variant myocardial infarction 6. Patients with severe liver diseases or lung diseases and/or malignant tumor with life expectancy of less than 3 years 7. Patients with severe valvular heart disease 8. Patients who are hypersensitive or prohibited from using the active substance (Ezetimibe or Rosuvastatin) of the study medicines 9. Patients with cardiogenic shock 10. Pregnant women or women who are planning to get pregnant 11. Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure 12. Patients who participated in other clinical studies within the past three months (except for non-interventional observation studies)
Contact & Investigator
Sung-ho Her, MD.PhD
PRINCIPAL INVESTIGATOR
St Vincent's Hospital
Frequently Asked Questions
Who can join the NCT06186037 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06186037 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06186037 currently recruiting?
Yes, NCT06186037 is actively recruiting participants. Contact the research team at hhhsungho@naver.com for enrollment information.
Where is the NCT06186037 trial being conducted?
This trial is being conducted at Suwon, South Korea.
Who is sponsoring the NCT06186037 clinical trial?
NCT06186037 is sponsored by Saint Vincent's Hospital, Korea. The principal investigator is Sung-ho Her, MD.PhD at St Vincent's Hospital. The trial plans to enroll 6,356 participants.