NCT05984537

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

A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, investigators enrolled patients with coronary heart disease who were scheduled to undergo percutaneous coronary intervention (PCI) and had high-risk plaques according to computed tomography angiography (CTA). During the PCI procedure, patients will be randomly assigned to receive either bivalirudin or standard heparin anticoagulation therapy. Investigators will compare the post-PCI coronary angiography-derived index of microcirculatory resistance (CaIMR), thrombolysis in myocardial infarction (TIMI) blood flow grade, CTFC (corrected TIMI frame count), TIMI myocardial perfusion grading(TMPG), levels of troponin, and major adverse cardiac events (MACE) during a follow-up period of 6 months between the two groups. Investigators aim to explore the potential benefits of bivalirudin perioperative anticoagulation therapy in improving coronary microvascular dysfunction (CMD) after PCI for high-risk plaques in coronary artery lesions.

Detailed description

Coronary artery disease (CAD) is one of the leading causes of death in China, with nearly 11.39 million patients affected. Percutaneous coronary intervention (PCI) is an important treatment for CAD, but despite effectively improving coronary stenosis, patients still experience the phenomenon of no-reflow (NR), which seriously affects long-term prognosis. Coronary microvascular dysfunction (CMD) during PCI is an important mechanism of NR, and previous studies have shown that immediate post-PCI CMD significantly affects long-term prognosis. Previous studies have shown that high-risk plaques identified by computed tomography angiography (CTA) before surgery in patients with stable coronary heart disease are closely related to the occurrence of NR and can serve as a predictor of NR after PCI. Therefore, CTA can identify high-risk patients for NR before PCI and has clinical value in preventing NR. Bivalirudin is a direct thrombin inhibitor that can block the continued development of blood clots. BIVAL study has shown that bivalirudin can improve post-PCI microcirculation dysfunction in patients with acute ST-segment elevation myocardial infarction, and animal experiments have shown that bivalirudin can improve thrombin-induced endothelial hyperpermeability. In this study, investigators plan to identify high-risk coronary artery plaques early through CTA examination. Participants will be randomly assigned to receive either bivalirudin or standard heparin anticoagulation therapy. Investigators will compare the post-PCI CaIMR, thrombolysis in myocardial infarction (TIMI) blood flow grade, CTFC (corrected TIMI frame count), TIMI myocardial perfusion grading(TMPG), levels of troponin, and major adverse cardiac events (MACE) during a follow-up period of 6 months between the two groups. Investigators will also explore the possible mechanisms by which bivalirudin reduces coronary microcirculatory injury and improves endothelial function through the detection of endothelial function-related biomarkers, providing evidence for the multi-effectiveness of bivalirudin in myocardial protection.

Conditions

• Coronary Microvascular Dysfunction

Interventions

Type	Name	Description
DRUG	Bivalirudin	Participants in the bivalirudin group received a one-time intravenous injection of 0.75 mg/kg during PCI, and then received a continuous intravenous infusion of 1.75 mg/kg/h for 4 hours according to the participants' condition after PCI.
DRUG	standard heparin	Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-01
• Completion: 2026-01-04
• First posted: 2023-08-09
• Last updated: 2025-08-12

Locations

1 site across 1 country: China