The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.
Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.
The First Affiliated Hospital of Dalian Medical University
Dalian, China
RECRUITINGMajor adverse cardiac events
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Time frame: 7 days
Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
Time frame: 7 days
Major adverse cardiac events
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Time frame: 30 days
Stent thrombosis ,TVR ,TLR
Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation.
Time frame: 30 days
Major adverse cardiac events
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Time frame: 180 days
Stent thrombosis ,TVR ,TLR
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Time frame: 180 days
Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
Time frame: 30 days
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Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
Time frame: 180days