Status:
RECRUITING
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
Lead Sponsor:
Peking University First Hospital
Conditions:
Coronary Microvascular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tomogr...
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, b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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, and 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 4 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05984537
Start Date
July 1 2023
End Date
January 4 2026
Last Update
August 12 2025
Active Locations (1)
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1
Peking university first hospital
Beijing, Beijing Municipality, China, 10034