Status
Recruiting
Phase
Phase 4
Enrollment
70
Locations
1
Results
Not posted
Publications
0
Study 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.
Coronary artery disease (CAD) is one of the leading causes of death in China, with nearly 11.39 million patients affected. Percutaneous coronary intervention (PCI) is an important treatment for CAD, but despite effectively improving coronary stenosis, patients still experience the phenomenon of no-reflow (NR), which seriously affects long-term prognosis. Coronary microvascular dysfunction (CMD) during PCI is an important mechanism of NR, and previous studies have shown that immediate post-PCI CMD significantly affects long-term prognosis. Previous studies have shown that high-risk plaques identified by computed tomography angiography (CTA) before surgery in patients with stable coronary heart disease are closely related to the occurrence of NR and can serve as a predictor of NR after PCI. Therefore, CTA can identify high-risk patients for NR before PCI and has clinical value in preventing NR. Bivalirudin is a direct thrombin inhibitor that can block the continued development of blood clots. BIVAL study has shown that bivalirudin can improve post-PCI microcirculation dysfunction in patients with acute ST-segment elevation myocardial infarction, and animal experiments have shown that bivalirudin can improve thrombin-induced endothelial hyperpermeability. In this study, investigators plan to identify high-risk coronary artery plaques early through CTA examination. Participants will be randomly assigned to receive either bivalirudin or standard heparin anticoagulation therapy. Investigators will compare the post-PCI 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 will also explore the possible mechanisms by which bivalirudin reduces coronary microcirculatory injury and improves endothelial function through the detection of endothelial function-related biomarkers, providing evidence for the multi-effectiveness of bivalirudin in myocardial protection.
Interventions
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.
DRUG
Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.
Timeline
First posted
Aug 9, 2023
Study start
Jul 1, 2023
Primary completion
Dec 1, 2025
Study completion
Jan 4, 2026
Results posted
Not reported
Registry updated
Aug 12, 2025
Outcomes
CaIMR
Time frame · 3 days
The caIMR value of the target vessel immediately after PCI.
CMD
Time frame · 3 days
The proportion of target vessels with caIMR ≥ 25 and caIMR ≥ 40 immediately after PCI.
clinical events
Time frame · 6 months
(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.
biomarker_eNOs
Time frame · 3 days
Serum levels of eNOs after PCI.
biomarker_ET-1
Time frame · 3 days
Serum levels of ET-1 after PCI.
biomarker_myocardial injury markers
Time frame · 3 days
Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.
imaging examination_microcirculation
Time frame · 3 days
Other indicators for assessing microcirculation during the procedure (including TMPG, TIMI frame count, and myocardial staining grade).
imaging examination_longitudinal myocardial strain
Time frame · 3 days
Changes in global longitudinal myocardial strain of the left ventricle measured by post-PCI echocardiography compared to baseline values.
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Peking university first hospital
Beijing, Beijing Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Duke University · Coronavirus Infection (COVID-19) · Pulmonary Arterial Hypertension
Not applicable
Recruiting
5,000
2026-07
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Xiaotong Hou · Extracorporeal Membrane Oxygenation Complication
Not applicable
Recruiting
154
2026-04
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
Boston Children's Hospital · Drug Effect
Not applicable
Recruiting
30
2025-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.