Back to resultsReduce Bolus Injection of Bivalirudin
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bivalirudin
Bivalirudin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring bivalirudin, bolus injection, activated clotting time, Renal insufficiency
Eligibility Criteria
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.
Sites / Locations
- General Hospital of Northern Theater Command
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Experimental
Arm Label
Low dose group with eGFR ≥60ml/min
Standard dose group with eGFR ≥ 60ml/min
Standard dose group with eGFR <60ml/min
Low dose group with eGFR <60ml/min
Arm Description
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.
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 .
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 .
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03588611
Brief Title
Reduce Bolus Injection of Bivalirudin
Official Title
The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 26, 2021 (Actual)
Study Completion Date
June 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Yaling, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
bivalirudin, bolus injection, activated clotting time, Renal insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose group with eGFR ≥60ml/min
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard dose group with eGFR ≥ 60ml/min
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Standard dose group with eGFR <60ml/min
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Low dose group with eGFR <60ml/min
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
Primary Outcome Measure Information:
Title
The area under the curve of the ACT values for both groups
Description
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.
Time Frame
During operation
Secondary Outcome Measure Information:
Title
Incidence of bleeding and ischaemic events during hospitalization after surgery .
Description
Bleeding events are defined as BARC grade 1-5. Ischemic events are defined as stroke, nonfatal myocardial reinfarction, ischemic-driven target vessel revascularization.
Time Frame
In hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35548446
Citation
Hu Q, Han YL, Zhou TN, Wang XZ, Zhang QY. Efficacy and Safety of the Reduced Bivalirudin in Patients Undergoing Coronary Angiography or Percutaneous Coronary Intervention Stratified by Renal Function (REDUCE BOLUS): A Single-Blind, Stratified Randomized, Non-inferiority Trial. Front Cardiovasc Med. 2022 Apr 25;9:864048. doi: 10.3389/fcvm.2022.864048. eCollection 2022.
Results Reference
derived
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Reduce Bolus Injection of Bivalirudin
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