Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05984537

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

Led by Peking University First Hospital · Updated on 2025-08-12

70

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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 less than 30 ml/min/1.73m2) or 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 fully 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking university first hospital

Beijing, Beijing Municipality, China, 10034

Actively Recruiting

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Research Team

B

Bo Zheng, Prof

CONTACT

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