Reduce Bolus Injection of Bivalirudin

Study Overview
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Brief Summary
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There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority, randomized, stratified controlled trial study has been conducted to evaluate the non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients with or without CKD.This study will provide a safe, effective and economical anticoagulation strategy.

Official Title
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The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Bivalirudin
* Drug: Bivalirudin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 Age 18 to 80 years old; 2 Medically judge to require coronary angiography; 3 Patients agree to use bivalirudin 4 Patients signe informed consent. Exclusion Criteria: 1.Cardiogenic shock; 2.Thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; 3.Active or recent major bleeding or bleeding predisposition; 4.Major surgery within 1 month; 5.Clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; blood pressure higher than 180/110 mm Hg; 6.Known hemoglobin less than 10 g/dL,platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal; 7.History of heparin-induced thrombocytopenia; 8.Ellergy to any of the study drugs or devices; 9.Eregnancy or lactation; 10.Any condition making PCI unsuitable or that might interfere with study adherence; 11.Patient unwilling or unable to provide written informed consent 12. Researchers think it is not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group with eGFR ≥60ml/min<br>This arm, we will choose the patients who's eGFR ≥60ml/min and reduce the bivalirudin bolus injection dose to 80% of the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery to reduce the ACT value caused by the bolus injection. | Drug: Bivalirudin<br>* 0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;<br>|
| Active Comparator: Standard dose group with eGFR ≥ 60ml/min<br>This arm, we will choose the patients who's eGFR ≥60ml/min and use the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery . | Drug: Bivalirudin<br>* 0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;<br>|
| Active Comparator: Standard dose group with eGFR <60ml/min<br>This arm, we will choose the patients who's eGFR <60ml/min and use the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery . | Drug: Bivalirudin<br>* 0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;<br>|
| Experimental: Low dose group with eGFR <60ml/min<br>This arm, we will choose the patients who's eGFR <60ml/min and reduce the bivalirudin bolus injection dose to 80% of the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery to reduce the ACT value caused by the bolus injection. | Drug: Bivalirudin<br>* 0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curve of the ACT values for both groups | We will record the ACT values of 0 min, 5 min, 10 min, and 30 min after bolus injection of bivalirudin in patients undergoing PCI,and the area of the closed pattern under the curve will be calculated, and the anticoagulant effect of bivalirudin will be evaluated by the area under the ACT line. | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding and ischaemic events during hospitalization after surgery . | Bleeding events are defined as BARC grade 1-5. Ischemic events are defined as stroke, nonfatal myocardial reinfarction, ischemic-driven target vessel revascularization. | In hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bivalirudin, bolus injection, activated clotting time, Renal insufficiency