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

Coronary Microvascular Dysfunction Clinical Trial

— PCI  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984537
• Other study ID #: ZHENG Bo.
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: March 4, 2025

Study information

• Verified date: April 2024
• Source: Peking University First Hospital
• Contact: Bo Zheng, Prof
• Phone: 13426046980
• Email: zhengbopatrick[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 4, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Microvascular Dysfunction

Intervention

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.
• standard heparin
Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.

Locations

Country	Name	City	State
China	Peking university first hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CaIMR	The caIMR value of the target vessel immediately after PCI.	3 days
Primary	CMD	The proportion of target vessels with caIMR = 25 and caIMR = 40 immediately after PCI.	3 days
Secondary	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
Secondary	biomarker_eNOs	Serum levels of eNOs after PCI.	3 days
Secondary	biomarker_ET-1	Serum levels of ET-1 after PCI.	3 days
Secondary	biomarker_myocardial injury markers	Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.	3 days
Secondary	imaging examination_microcirculation	Other indicators for assessing microcirculation during the procedure (including TMPG, TIMI frame count, and myocardial staining grade).	3 days
Secondary	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