A Phase 4 interventional study of bivalirudin and Heparin in Coronary Disease, sponsored by Chinese PLA General Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by Chinese PLA General Hospital · Phase 4, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 1,770 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.
Drug: Heparin
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .
Drug: bivalirudin
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.
Drug: bivalirudin
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
Heparin is used in patients undergoing percutaneous coronary intervention.
creatine kinase-MB increase
creatine kinase-MB increase \>3 times upper limit of normal
Time frame: up to postprocedural 72 hours
bleeding（BARC class）
including BARC class 2-5
Time frame: 30 days and 1 year
major adverse cardiac or cerebral events
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Time frame: 30 days and 1 year
Net Adverse Clinical Events
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding
Time frame: 30 days and 1 year
Plan to share: Undecided
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Chinese PLA General Hospital