Coronary Microvascular DysfunctionPhase 4PCINCT05984537
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
A Phase 4 study testing Bivalirudin and standard heparin in people with Coronary Microvascular Dysfunction, run by Peking University First Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction
- What is being tested?
- Bivalirudin and standard heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 4 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking university first hospital
Beijing, Beijing Municipality, 10034
Bo Zheng, Prof, 13426046980, zhengbopatrick@163.com
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Coronary Microvascular Dysfunction
- Being tested
- Bivalirudin, standard heparin
- Keywords
- coronary microvascular dysfunction, computed tomography angiography, percutaneous coronary intervention, bivalirudin, heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called bivalirudin anticoagulation
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 heparinDrug
Also called standard heparin anticoagulation
Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.
| Study group | Role | What they receive |
|---|---|---|
| bivalirudin group | Experimental | participants using bivalirudin during PCI Receives: Drug: Bivalirudin |
| standard heparin group | Active comparator | participants using standard heparin during PCI Receives: Drug: standard heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CaIMR
The caIMR value of the target vessel immediately after PCI.
Measured: 3 days
CMD
The proportion of target vessels with caIMR ≥ 25 and caIMR ≥ 40 immediately after PCI.
Measured: 3 days
Secondary outcomes (6)
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.
Measured: 6 months
biomarker_eNOs
Serum levels of eNOs after PCI.
Measured: 3 days
biomarker_ET-1
Serum levels of ET-1 after PCI.
Measured: 3 days
biomarker_myocardial injury markers
Peak levels of myocardial injury markers (CK-MB and CTNI) after PCI.
Measured: 3 days
imaging examination_microcirculation
Other indicators for assessing microcirculation during the procedure (including TMPG, TIMI frame count, and myocardial staining grade).
Measured: 3 days
imaging examination_longitudinal myocardial strain
Changes in global longitudinal myocardial strain of the left ventricle measured by post-PCI echocardiography compared to baseline values.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion4 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DysfunctionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- single-center
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHENG Bo, Peking University First Hospital
- Investigators
- Bo Zheng, Prof, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984537
- Sponsor's protocol ID
- ZHENG Bo.
- Acronym
- PCI
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05984537
- Acronym / sponsor ID
- PCI / ZHENG Bo.
- Conditions
- Coronary Microvascular Dysfunction
- Keywords
- coronary microvascular dysfunction, computed tomography angiography, percutaneous coronary intervention, bivalirudin, heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 4 Jan 2026 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-center
| Arm | Type | Receives |
|---|---|---|
| bivalirudin group | Experimental | Drug: Bivalirudinparticipants using bivalirudin during PCI |
| standard heparin group | Active comparator | Drug: standard heparinparticipants using standard heparin during PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BivalirudinAlso: bivalirudin anticoagulationParticipants 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 | bivalirudin group |
| standard heparinAlso: standard heparin anticoagulationParticipants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI. | Drug | standard heparin group |
Primary outcome
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.
6 secondary outcomes
clinical events
Time frame: 6 months
biomarker_eNOs
Time frame: 3 days
biomarker_ET-1
Time frame: 3 days
biomarker_myocardial injury markers
Time frame: 3 days
imaging examination_microcirculation
Time frame: 3 days
imaging examination_longitudinal myocardial strain
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Zheng, Prof principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin and standard heparin in people with Coronary Microvascular Dysfunction, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Zheng, Prof (13426046980, zhengbopatrick@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CaIMR (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.