Impact of Bivalirudin on Coronary Microcirculation During PCI

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.

This study is testing if using bivalirudin instead of standard heparin during heart procedures can help people with coronary heart disease have better blood flow in their tiny heart vessels and improve their long-term health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05984537 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-ST-segment elevation myocardial infarction or unstable angina, scheduled for elective coronary angiography and intervention, and identified as having high-risk plaques.

Not a fit: Patients with severe comorbidities, recent PCI, or those with certain contraindications will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of coronary microvascular dysfunction, enhancing patient outcomes after PCI.

How similar studies have performed: Previous studies have shown that bivalirudin can improve microcirculation dysfunction in acute myocardial infarction, suggesting potential success for this approach in similar contexts.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions: Coronary Microvascular Dysfunction, coronary microvascular dysfunction, computed tomography angiography, percutaneous coronary intervention, bivalirudin, heparin