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NOT YET RECRUITING
NCT07577518
NA

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: Percutaneous Intervention Versus Optimal Medical Therapy in Chronic Coronary Syndrome (PIVOT) Trial

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2301

Start Date

2026-06-15

Completion Date

2034-03-10

Last Updated

2026-06-12

Healthy Volunteers

No

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.

Locations (20)

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

GangNeung Asan Hospital

Gangneung, Gangwon-do, South Korea

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Bucheon Sejong Hospital

Bucheon-si, Gyeonggi-do, South Korea

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Samsung Changwon Medical Center

Changwon, Gyeongsangnam-do, South Korea

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