Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
Primary Purpose
Coronary Disease
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
bivalirudin
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring bivalirudin, myocardial injure
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.
Exclusion Criteria:
- cardiogenic shock;
- thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization;
- active or recent major bleeding or bleeding predisposition;
- major surgery within 1 month;
- clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis;
- blood pressure higher than 180/110 mm Hg;
- known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min;
- history of heparin-induced thrombocytopenia;
- allergy to any of the study drugs or devices;
- pregnancy or lactation;
- any condition making PCI unsuitable or that might interfere with study adherence; and
- patient unwilling or unable to provide written informed consent.
Sites / Locations
- ChinaPLAGH
- ChinaPLAGH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
heparin
not prolong infusion Bivalirudin
prolong infusion bivalirudin
Arm Description
For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure.
Outcomes
Primary Outcome Measures
creatine kinase-MB increase
creatine kinase-MB increase >3 times upper limit of normal
Secondary Outcome Measures
bleeding(BARC class)
including BARC class 2-5
major adverse cardiac or cerebral events
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Net Adverse Clinical Events
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding
Full Information
NCT ID
NCT02787317
First Posted
May 24, 2016
Last Updated
May 31, 2016
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02787317
Brief Title
Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
Official Title
Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
Detailed Description
Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
bivalirudin, myocardial injure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1770 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
heparin
Arm Type
Active Comparator
Arm Description
For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.
Arm Title
not prolong infusion Bivalirudin
Arm Type
Experimental
Arm Description
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .
Arm Title
prolong infusion bivalirudin
Arm Type
Experimental
Arm Description
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure.
Intervention Type
Drug
Intervention Name(s)
bivalirudin
Intervention Description
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Heparin is used in patients undergoing percutaneous coronary intervention.
Primary Outcome Measure Information:
Title
creatine kinase-MB increase
Description
creatine kinase-MB increase >3 times upper limit of normal
Time Frame
up to postprocedural 72 hours
Secondary Outcome Measure Information:
Title
bleeding(BARC class)
Description
including BARC class 2-5
Time Frame
30 days and 1 year
Title
major adverse cardiac or cerebral events
Description
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Time Frame
30 days and 1 year
Title
Net Adverse Clinical Events
Description
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding
Time Frame
30 days and 1 year
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:
Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.
Exclusion Criteria:
cardiogenic shock;
thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization;
active or recent major bleeding or bleeding predisposition;
major surgery within 1 month;
clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis;
blood pressure higher than 180/110 mm Hg;
known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min;
history of heparin-induced thrombocytopenia;
allergy to any of the study drugs or devices;
pregnancy or lactation;
any condition making PCI unsuitable or that might interfere with study adherence; and
patient unwilling or unable to provide written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yundai chen, doctor
Phone
+08613581886786
Email
dingyutinkle@163.com
Facility Information:
Facility Name
ChinaPLAGH
City
Beijing
State/Province
Beijing
ZIP/Postal Code
1000853
Country
China
Facility Name
ChinaPLAGH
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yundai chen
Phone
08601055499309
Email
dingyutinkle@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25775052
Citation
Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323.
Results Reference
background
PubMed Identifier
19801025
Citation
Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.
Results Reference
result
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Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
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