Coronary Disease
Conditions
Keywords
bivalirudin, myocardial injure
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.
Interventions
DRUGbivalirudin
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
DRUGHeparin
Heparin is used in patients undergoing percutaneous coronary intervention.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| creatine kinase-MB increase | up to postprocedural 72 hours | creatine kinase-MB increase \>3 times upper limit of normal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bleeding（BARC class） | 30 days and 1 year | including BARC class 2-5 |
| major adverse cardiac or cerebral events | 30 days and 1 year | a composite of all cause death, reinfarction, target vessel revascularization or stroke |
| Net Adverse Clinical Events | 30 days and 1 year | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding |
Countries
China
Contacts
Primary ContactYundai chen, doctor
Outcome results
None listed