Impact of Bivalirudin Compared to Heparin During Coronary Intervention for High-Risk Plaques on Heart Microcirculation

What this Trial Is About

Researchers are evaluating patients with coronary heart disease who have high-risk plaques identified by computed tomography angiography CTA and are scheduled for percutaneous coronary intervention PCI. The study aims to compare the effects of bivalirudin and standard heparin anticoagulation therapies on coronary microvascular dysfunction CMD following PCI. This research includes measuring post-PCI blood flow and heart muscle damage markers to explore potential improvements in microcirculation and long-term heart outcomes. Participants will be randomly assigned to one of two groups during their PCI procedure one group will receive bivalirudin, starting with a single intravenous dose of 0.75 mgkg followed by a continuous infusion of 1.75 mgkg per hour for 4 hours after PCI the other group will receive a single intravenous dose of 50 Ukg of standard heparin. The study includes a follow-up period of 6 months to monitor clinical events and heart function. The research also investigates how bivalirudin might protect the heart by examining related biomarkers. During the study, participants will undergo assessments including coronary angiography-derived index of microcirculatory resistance CaIMR, blood flow grading, frame count corrections, myocardial perfusion grading, and troponin level measurements. Imaging evaluations and biomarkers related to endothelial function and myocardial injury will be collected within 3 days after PCI. Researchers will track major adverse cardiac events over 6 months. The trial is designed to monitor safety and effectiveness of treatments throughout the study period, with participation lasting approximately 6 months post-procedure.

A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.