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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Bivalirudin

    Drug

    Participants in the bivalirudin group received a one-time intravenous injection of 0.75 mg/kg during PCI, and then received a continuous intravenous infusion of 1.75 mg/kg/h for 4 hours according to the participants' condition after PCI.

  • standard heparin

    Drug

    Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: bivalirudin groupExperimental treatment 1 intervention
Group B: standard heparin groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

CaIMR

The caIMR value of the target vessel immediately after PCI.

Time frame
3 days
2

CMD

The proportion of target vessels with caIMR ≥ 25 and caIMR ≥ 40 immediately after PCI.

Time frame
3 days

Secondary outcomes

1

clinical events

(1) MACE (including cardiac death, target vessel revascularization, target vessel myocardial infarction, and heart failure readmission) at 30 days and 6 months after PCI; (2) Major adverse events (including all-cause death, non-fatal myocardial infarction, unplanned revascularization, definite or probable stent thrombosis, and clinically significant bleeding events) at 30 days and 6 months.

Time frame
6 months
2

biomarker_eNOs

Serum levels of eNOs after PCI.

Time frame
3 days
3

biomarker_ET-1

Serum levels of ET-1 after PCI.

Time frame
3 days
4

biomarker_myocardial injury markers

Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.

Time frame
3 days

Other outcomes

Sponsors and contacts

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