NCT05984537

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2026

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

July 23, 2023

Last Update Submit

August 7, 2025

Conditions

Coronary Microvascular Dysfunction

Keywords

coronary microvascular dysfunctioncomputed tomography angiographypercutaneous coronary interventionbivalirudinheparin

Outcome Measures

Primary Outcomes (2)

  • CaIMR

    The caIMR value of the target vessel immediately after PCI.

    3 days

  • CMD

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

    3 days

Secondary Outcomes (6)

  • clinical events

    6 months

  • biomarker_eNOs

    3 days

  • biomarker_ET-1

    3 days

  • biomarker_myocardial injury markers

    3 days

  • imaging examination_microcirculation

    3 days

  • +1 more secondary outcomes

Study Arms (2)

bivalirudin group

EXPERIMENTAL

participants using bivalirudin during PCI

Drug: Bivalirudin

standard heparin group

ACTIVE COMPARATOR

participants using standard heparin during PCI

Drug: standard heparin

Interventions

BivalirudinDRUG

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.

Also known as: bivalirudin anticoagulation
bivalirudin group
standard heparinDRUG

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

Also known as: standard heparin anticoagulation
standard heparin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • poor opacification of the target vessel, severe vessel overlap or distortion, and inability to completely 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university first hospital

Beijing, Beijing Municipality, 10034, China

RECRUITING

MeSH Terms

Interventions

bivalirudin

Study Officials

  • Bo Zheng, Prof

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Zheng, Prof

CONTACT

13426046980zhengbopatrick@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single-blind
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: single-center
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 9, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2025

Study Completion

January 4, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)