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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Microvascular Dysfunction
• Intervention / Treatment: Drug: Bivalirudin; Drug: standard heparin

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bo Zheng, Prof; Phone Number: 13426046980; Email: zhengbopatrick@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10034
      • Recruiting
      • Peking University First Hospital
      • Contact: Bo Zheng, Prof; Phone Number: 13426046980; Email: zhengbopatrick@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. aged 18 years or older;
2. diagnosed with non-ST-segment elevation myocardial infarction or unstable angina pectoris;
3. scheduled to undergo elective coronary angiography and intervention;
4. coronary computed tomography angiography showing high-risk plaque features within 3 months prior to the procedure;
5. voluntary participation in the study and signed informed consent.

Exclusion Criteria:

1. prior PCI of the target vessel within 3 months;
2. cardiogenic shock, active bleeding, bleeding disorders, irreversible coagulation dysfunction, severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR < 30 ml/min/1.73m2), and dependence on dialysis;
3. life expectancy less than 1 year;
4. chronic total occlusion of the target vessel;
5. poor opacification of the target vessel, severe vessel overlap or distortion, and inability to completely expose the lesion site;
6. allergy to contrast agents, verapamil, or its excipients;
7. severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
8. subacute bacterial endocarditis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bivalirudin group; participants using bivalirudin during PCI	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.; Other Names: bivalirudin anticoagulation
Active Comparator: standard heparin group; participants using standard heparin during 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.; Other Names: standard heparin anticoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CaIMR	The caIMR value of the target vessel immediately after PCI.	3 days
CMD	The proportion of target vessels with caIMR ≥ 25 and caIMR ≥ 40 immediately after PCI.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical events	(1) MACE (including cardiac death, target vessel revascularization, target vessel myocardial infarction, and heart failure readmission) at 30 days and 6 months after PCI; (2) Major adverse events (including all-cause death, non-fatal myocardial infarction, unplanned revascularization, definite or probable stent thrombosis, and clinically significant bleeding events) at 30 days and 6 months.	6 months
biomarker_eNOs	Serum levels of eNOs after PCI.	3 days
biomarker_ET-1	Serum levels of ET-1 after PCI.	3 days
biomarker_myocardial injury markers	Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.	3 days
imaging examination_microcirculation	Other indicators for assessing microcirculation during the procedure (including TMPG, TIMI frame count, and myocardial staining grade).	3 days
imaging examination_longitudinal myocardial strain	Changes in global longitudinal myocardial strain of the left ventricle measured by post-PCI echocardiography compared to baseline values.	3 days

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Bo Zheng, Prof, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 4, 2026

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; heparin; bivalirudin; coronary microvascular dysfunction; computed tomography angiography
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Antithrombins; Serine Proteinase Inhibitors; Heparin; Calcium heparin; Bivalirudin; Hirudins
• Other Study ID Numbers: ZHENG Bo.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No