BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial. (BRIGHT)
The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.
All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
|Acute Myocardial Infarction Percutaneous Coronary Intervention||Drug: Bivalirudin Drug: heparin Drug: heparin plus tirofiban||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial|
- Net Adverse Clinical Events [ Time Frame: 30 days ]A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
- Net adverse clinical events [ Time Frame: 1 year ]a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
- any bleedings (BARC class) [ Time Frame: 30 day ]including all BARC class (class 1-5)
- Major adverse cardiac and cerebral events (MACCE) [ Time Frame: 30 days and 1 year ]a composite of all cause death, reinfarction, target vessel revascularization or stroke
- Thrombocytopenia [ Time Frame: 30 days ]Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration
- stent thrombosis [ Time Frame: 30 days and 1 year ]by ARC definition
|Study Start Date:||August 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Other Name: Taijianing
Active Comparator: Heparin monotherapy
100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
Active Comparator: heparin plus tirofiban
heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
heparin monotherapyDrug: heparin plus tirofiban
combined use of heparin and tirofiban during PCI
Other Name: brand name of tirofiban: Xinweining
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696110
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|Principal Investigator:||Yaling Han, MD||Shenyang Northern Hospital,China|