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

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

Interventions

PROCEDURE

percutaneous coronary intervention

PCI will be performed in addition to optimal medical therapy.

DRUG

Guideline-directed Optimal Medical treatment

Guideline-directed optimal medical therapy alone without PCI

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical

  collaborator INDUSTRY

• Diomedical

  collaborator UNKNOWN

• Seoul National University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-27

Primary Completion

2030-04-27

Completion

2034-03-10

Countries

• South Korea

Study Locations