Actively Recruiting
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.
Led by Peking University First Hospital · Updated on 2025-08-12
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating patients with coronary heart disease who have high-risk plaques identified by computed tomography angiography (CTA) and are scheduled for percutaneous coronary intervention (PCI). The study aims to compare the effects of bivalirudin and standard heparin anticoagulation therapies on coronary microvascular dysfunction (CMD) following PCI. This research includes measuring post-PCI blood flow and heart muscle damage markers to explore potential improvements in microcirculation and long-term heart outcomes. Participants will be randomly assigned to one of two groups during their PCI procedure: one group will receive bivalirudin, starting with a single intravenous dose of 0.75 mg/kg followed by a continuous infusion of 1.75 mg/kg per hour for 4 hours after PCI; the other group will receive a single intravenous dose of 50 U/kg of standard heparin. The study includes a follow-up period of 6 months to monitor clinical events and heart function. The research also investigates how bivalirudin might protect the heart by examining related biomarkers. During the study, participants will undergo assessments including coronary angiography-derived index of microcirculatory resistance (CaIMR), blood flow grading, frame count corrections, myocardial perfusion grading, and troponin level measurements. Imaging evaluations and biomarkers related to endothelial function and myocardial injury will be collected within 3 days after PCI. Researchers will track major adverse cardiac events over 6 months. The trial is designed to monitor safety and effectiveness of treatments throughout the study period, with participation lasting approximately 6 months post-procedure.
CONDITIONS
Brief Title
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with non-ST-segment elevation myocardial infarction or unstable angina pectoris
- Scheduled to undergo elective coronary angiography and intervention
- Coronary computed tomography angiography showing high-risk plaque features within 3 months prior to the procedure
- Voluntary participation in the study and signed informed consent
You will not qualify if you...
- Prior PCI of the target vessel within 3 months
- 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
- Life expectancy less than 1 year
- Chronic total occlusion of the target vessel
- Poor opacification of the target vessel, severe vessel overlap or distortion, inability to completely expose the lesion site
- Allergy to contrast agents, verapamil, or its excipients
- Severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
- Subacute bacterial endocarditis
AI-Screening
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Your Study Journey
Duration - Up to 3 months prior to PCI
Participants are screened for eligibility to participate in the trial.
Duration - During PCI and up to 4 hours after PCI
Participants receive either bivalirudin or standard heparin anticoagulation therapy during PCI.
1 treatment visit (in-person)
Duration - 6 months after PCI
Participants are monitored for clinical events and biomarker levels to assess post-PCI coronary microcirculation and outcomes.
Follow-up assessments including biomarker and imaging evaluations at 3 days post-PCI and clinical event monitoring up to 6 months
Trial Site Locations
Total: 1 location
1
Peking university first hospital
Beijing, Beijing Municipality, China, 10034
Actively Recruiting
Research Team
B
Bo Zheng, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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