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

NCT07577518 | Not Yet Recruiting DMC

• 1 other identifier: H-2601-092-1709
• Study Type: interventional
• Target: 2,301
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Chronic Coronary Syndrome

Keywords

chronic coronary syndrome; percutaneous coronary intervention; optimal medical therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  2nd year and 5th year since registration was complete

• Change in Seattle Angina Questionnaire-7 (SAQ-7) Summary Score from Baseline to 12 Months (for Nested RCT)

  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.

  One year after registration

Secondary Outcomes (15)

• Number of Participants with All-cause death

  2nd year and 5th year since registration was complete

• Number of Participants with Cardiovascular death

  2nd year and 5th year since registration was complete

• Number of Participants with Cardiovascular Death or Non-Fatal Myocardial Infarction

  2nd year and 5th year since registration was complete

• Number of Participants with Myocardial Infarction

  2nd year and 5th year since registration was complete

• Number of Participants with Spontaneous myocardial infarction

  2nd year and 5th year since registration was complete

Study Arms (2)

PCI

EXPERIMENTAL

PCI will be performed in addition to guideline-directed optimal medical therapy

Procedure: percutaneous coronary intervention; Drug: Guideline-directed Optimal Medical treatment; Drug: Carvedilol Sustained-Release (SR) (Nested RCT subset); Drug: Carvedilol Immediate-Release (IR) (Nested RCT subset)

Guideline-directed Optimal Medical treatment

ACTIVE COMPARATOR

Optimal medical therapy alone without PCI

Drug: Guideline-directed Optimal Medical treatment; Drug: Carvedilol Sustained-Release (SR) (Nested RCT subset); Drug: Carvedilol Immediate-Release (IR) (Nested RCT subset)

Interventions

percutaneous coronary intervention PROCEDURE

PCI will be performed in addition to optimal medical therapy.

PCI

Guideline-directed Optimal Medical treatment DRUG

Guideline-directed optimal medical therapy alone without PCI

Guideline-directed Optimal Medical treatment; PCI

Carvedilol Immediate-Release (IR) (Nested RCT subset) DRUG

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.

Guideline-directed Optimal Medical treatment; PCI

Carvedilol Sustained-Release (SR) (Nested RCT subset) DRUG

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.

Guideline-directed Optimal Medical treatment; PCI

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40 years or older
• Patients suspected of having chronic coronary syndrome who have undergone coronary angiography and confirmed stenotic lesions
• Patients with lesions suitable for stent insertion who have 50% or more visually estimated stenosis in major coronary arteries with a diameter of 2.5 mm or greater observed on coronary angiography, and who satisfy one or more of the following conditions:
• Patients with stenosis of 70% or more confirmed via Quantitative coronary angiography (50% or more for the left main coronary artery)
• Minimum lumen area (MLA) ≤ 4 mm² or plaque burden \>70% on intravascular ultrasound (IVUS)
• MLA \<3.5 mm² or area stenosis (AS) \>65% on Optical Coherence Tomography (OCT)
• The corresponding stenosis on localizing stress imaging using SPECT or PET When there is a significant focal ischemic deficit in the coronary artery region of the lesion and the total perfusion deficit (TPD) is ≥10%
• Pressure wire-based fractional flow reserve (FFR) ≤0.80
• Patients who can verbally confirm their understanding of invasive physiological or imaging evaluations and the benefits, harms, and alternative treatments of coronary angioplasty using drug-eluting stents, and for whom the patient or their legal representative can submit a written consent form.
• Additional Criteria for nested RCT Studies
• When heart rate control is deemed therapeutically important due to an accompanying increase in heart rate at rest or during symptomatic episodes.
• When the use of beta-blockers is deemed clinically advantageous due to a history of myocardial infarction.
• When beta-blockers can help control blood pressure and symptoms in cases of concomitant hypertension.
• When there is a clinical situation requiring associated tachyarrhythmia or heart rate control.
• When beta-blockers are deemed more appropriate due to a history of contraindications, intolerance, or side effects of calcium channel blockers.

You may not qualify if:

• Patients with Left Ventricular Ejection Fraction (LVEF) less than 35%
• Patients with cardiogenic shock
• Patients with pulmonary edema or heart failure unresponsive to standard treatment
• Patients with unstable angina whose symptoms persist despite maximal drug therapy
• Patients with a history of ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina within the last 6 months
• Patients with active bleeding
• Patients with major bleeding of the gastrointestinal or urinary system within the last 3 months
• Patients with coagulation disorders prone to bleeding (including heparin-induced thrombocytopenia)
• Patients with hypersensitivity to or contraindications to the following drugs: Heparin, Aspirin, Clopidogrel, Prasugrel, Contrast media (Patients sensitive to contrast media are not excluded if the condition can be effectively prevented through pretreatment with steroids or diphenhydramine (e.g., flare-ups).
• Patients for whom percutaneous coronary intervention (PCI) is contraindicated
• Patients who have already undergone coronary artery bypass grafting (CABG)
• Patients with in-stent restenosis in the target lesion
• Patients with chronic total occlusion (CTO) in major coronary arteries
• Patients with lesions having an FFR of less than 0.64
• Patients with coronary arteries that are anatomically unsuitable for both PCI and CABG

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Chong Kun Dang Pharmaceutical: collaborator
• Diomedical: collaborator

Study Sites (20)

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

GangNeung Asan Hospital

Gangneung, Gangwon-do, 25440, South Korea

Location

Hallym University Medical Center

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Bucheon Sejong Hospital

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Samsung Changwon Medical Center

Changwon, Gyeongsangnam-do, 51353, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

The Catholic University of Korea Daejeon St. Mary's Hospital

Daejeon, 34943, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chungnam National University Hospital

Gwangju, 61469, South Korea

Location

Jeju National University Hospital

Jeju City, 63241, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Ewha Womans University Medical Center

Seoul, 07804, South Korea

Location

Koera University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan Univeristy Hospital

Ulsan, 44033, South Korea

Location

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MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Jung-Kyu Han, MD, PhD

CONTACT

+82-2-2072-4870; hpcrates@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 27, 2030
• Study Completion (Estimated): March 10, 2034
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (20)