Clinical Trial

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

Study acronym: PCI
Recruiting Phase 4
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Record status
This record was last updated August 12, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-08-01; most recent amendment 2025-08-07.
Status change: Active, Not Recruiting → Recruiting 2024-04-01
Trial Details
NCT Number NCT05984537
Lead Sponsor Peking University First Hospital
Conditions Coronary Microvascular Dysfunction
Enrollment 70 participants
Start Date 2023-07-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-01-04 (estimated)
Updated on ClinicalTrials.gov 2025-08-12