NCT05984537 A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
| NCT ID | NCT05984537 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Coronary Microvascular Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2023-07-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Bo Zheng, Prof
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT05984537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Microvascular Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05984537 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05984537 currently recruiting?
Yes, NCT05984537 is actively recruiting participants. Contact the research team at zhengbopatrick@163.com for enrollment information.
Where is the NCT05984537 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05984537 clinical trial?
NCT05984537 is sponsored by Peking University First Hospital. The principal investigator is Bo Zheng, Prof at Peking University First Hospital. The trial plans to enroll 70 participants.