Clinical Trial

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

Study acronym: PIVOT
Not Yet Recruiting
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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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-05-20
notable Trial sites expanded: 17 -> 20 locations 2026-05-20
Trial Details
NCT Number NCT07577518
Lead Sponsor Seoul National University Hospital
Collaborators: Chong Kun Dang Pharmaceutical, Diomedical
Conditions Chronic Coronary Syndrome
Enrollment 2,301 participants
Start Date 2026-06-15
Primary Completion 2030-04-27 (estimated)
Study Completion 2034-03-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-12