Impact of Bivalirudin on Coronary Microcirculation During PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of bivalirudin compared to standard heparin during percutaneous coronary intervention (PCI) in patients with coronary heart disease and high-risk plaques identified by computed tomography angiography. Participants will be randomly assigned to receive either bivalirudin or heparin, and various measures of coronary microvascular function will be assessed post-procedure. The study aims to determine if bivalirudin can improve outcomes related to coronary microvascular dysfunction, which is linked to long-term prognosis after PCI. Follow-up will occur over a six-month period to evaluate major adverse cardiac events and other relevant metrics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking university first hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Bo Zheng, Prof — Peking University First Hospital
• Study coordinator: Bo Zheng, Prof
• Email: zhengbopatrick@163.com
• Phone: 13426046980

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.