Comparison of the Incidence of Major Cardiovascular Events Between the Combination of Percutaneous Intervention and Optimal Drug Therapy and the Optimal Drug Therapy Alone in Patients With Chronic Coronary Syndrome
Condition(s) studied
Investigational drug(s) / intervention(s)
percutaneous coronary intervention: PCI will be performed in addition to optimal medical therapy.
Guideline-directed Optimal Medical treatment: Guideline-directed optimal medical therapy alone without PCI
Carvedilol Sustained-Release (SR) (Nested RCT subset): Carvedilol SR (Dilatrend SR; 8/16/32/64 mg) once daily, starting at 32 mg and up-titrated to maximal tolerated dose (up to 128 mg). Applied to Nested RCT participants only (n=220 total across both arms), in whom eligible participants are independently randomized 1:1 to either carvedilol SR or IR - only one formulation is assigned per participant.
Carvedilol Immediate-Release (IR) (Nested RCT subset): Carvedilol IR (Dilatrend; 3.125/6.25/12.5/25 mg) twice daily, starting at 12.5 mg BID and up-titrated to maximal tolerated dose (up to 50 mg BID). Applied to Nested RCT participants only (n=220 total across both arms), in whom eligible participants are independently randomized 1:1 to either carvedilol SR or IR - only one formulation is assigned per participant.
Study summary
Comparison of the incidence of major cardiovascular events between the combination of percutaneous intervention and optimal drug therapy and the optimal drug therapy alone in patients with chronic coronary syndrome.
* Main RCT (Randomized Clinical Trial): Patients with chronic coronary syndrome enrolled in the study will be randomized in a 1:1 ratio to either 1) PCI(Percutaneous Coronary Intervention) plus optimal medical therapy or 2) optimal medical therapy alone, with clinical outcomes assessed during follow-up. (2,301 participants)
* Nested RCT: An embedded randomized supplementary study was conducted on a subset (220 participants) of the total subjects.
In patients who have decided to use beta-blockers for the control of angina, additional 1:1 randomization evaluates the efficacy of carvedilol sustained-release (SR) and immediate-release (IR) formulations. Both formulations are targeted for use up to the maximal tolerated dose, taking into account patient symptoms.
Eligibility
Primary outcome measure(s)
- Number of Participants with Patient-oriented composite outcome (POCO), defined as the composite of cardiovascular death, non-fatal myocardial infarction (MI), or clinically driven revascularization — 2nd year and 5th year since registration was complete
This outcome applies to the main RCT (n=2,301). POCO is a composite of three components: (1) cardiovascular death; (2) non-fatal myocardial infarction, excluding periprocedural MI; and (3) clinically driven revascularization. The first occurrence of any component is counted as the primary event per participant. Clinically driven revascularization is defined as revascularization of a coronary segment with diameter stenosis ≥50% by quantitative coronary angiography, accompanied by at least one of the following: ischemic ECG(Electrocardiogram) changes at rest; typical ischemic symptoms refractory to medical therapy; unstable angina; positive invasive physiologic test (FFR(Fractional Flow Reserve) ≤0.80 or iFR (Instantaneous Wave-Free Ratio) ≤0.89); or angiographic progression with diameter stenosis ≥70% by quantitative coronary angiography regardless of other criteria. - Change in Seattle Angina Questionnaire-7 (SAQ-7) Summary Score from Baseline to 12 Months (for Nested RCT) — One year after registration
This outcome applies to the Nested RCT substudy only (n=220), in which participants eligible for beta-blocker therapy are independently randomized 1:1 to carvedilol SR or IR, regardless of their main trial allocation. The SAQ-7 is a 7-item validated questionnaire assessing angina-related health status across three domains: physical limitation, angina frequency, and quality of life. Scores range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ-7 Summary score is calculated as the mean of the three domain scores.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Kangwon National University Hospital | Chuncheon | Gangwon-do | |
| GangNeung Asan Hospital | Gangneung | Gangwon-do | |
| Hallym University Medical Center | Anyang-si | Gyeonggi-do | |
| Bucheon Sejong Hospital | Bucheon-si | Gyeonggi-do | |
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | |
| Samsung Changwon Medical Center | Changwon | Gyeongsangnam-do | |
| Inje University Haeundae Paik Hospital | Busan | South Korea | |
| Pusan National University Hospital | Busan | South Korea | |
| Kosin University Gospel Hospital | Busan | South Korea | |
| Keimyung University Dongsan Hospital | Daegu | South Korea | |
| Kyungpook National University Hospital | Daegu | South Korea | |
| The Catholic University of Korea Daejeon St. Mary's Hospital | Daejeon | South Korea | |
| Chungnam National University Hospital | Daejeon | South Korea | |
| Chungnam National University Hospital | Gwangju | South Korea | |
| Jeju National University Hospital | Jeju City | South Korea | |
| Kangdong Sacred Heart Hospital | Seoul | South Korea | |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | South Korea | |
| Ewha Womans University Medical Center | Seoul | South Korea | |
| Koera University Guro Hospital | Seoul | South Korea | |
| Ulsan Univeristy Hospital | Ulsan | South Korea |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07577518 on ClinicalTrials.gov ↗ ← All trials in South Korea