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

RecruitingPhase 4Ages 18 Years - anyAllPeking University First Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 160 mmHg and/or diastolic blood pressure โ‰ฅ 100 mmHg); 8. subacute bacterial endocarditis.
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What it tests

  • Bivalirudin
  • standard heparin
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Where

1 site
Peking university first hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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