DRUG
bivalirudin
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
Status
Unknown
Phase
Phase 4
Enrollment
1,770
Locations
2
Results
Not posted
Publications
2
Study 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.
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.
Interventions
DRUG
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
DRUG
Heparin is used in patients undergoing percutaneous coronary intervention.
Timeline
First posted
Jun 1, 2016
Study start
May 2016
Primary completion
Oct 2017
Study completion
Nov 2018
Results posted
Not reported
Registry updated
Jun 1, 2016
Outcomes
creatine kinase-MB increase
Time frame · up to postprocedural 72 hours
creatine kinase-MB increase \>3 times upper limit of normal
bleeding(BARC class)
Time frame · 30 days and 1 year
including BARC class 2-5
major adverse cardiac or cerebral events
Time frame · 30 days and 1 year
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Net Adverse Clinical Events
Time frame · 30 days and 1 year
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
ChinaPLAGH
Beijing, Beijing Municipality, China
ChinaPLAGH
Beijing, Beijing Municipality, China
Publications
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