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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
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
Conditions
Interventions
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.
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