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

Study acronym: PCI
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Mar 1, 2025 to Dec 1, 2025
    • Study completion date: Mar 4, 2025 to Jan 4, 2026
    v3
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Mar 1, 2024 to Mar 1, 2025
    • Study completion date: Mar 1, 2024 to Mar 4, 2025
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05984537
Lead Sponsor Peking University First Hospital
Conditions
(from sponsor)		 Coronary Microvascular Dysfunction
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov