BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial. (BRIGHT)
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|ClinicalTrials.gov Identifier: NCT01696110|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : October 1, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction Percutaneous Coronary Intervention||Drug: Bivalirudin Drug: heparin Drug: heparin plus tirofiban||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2014|
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.
Drug: heparin plus tirofiban
combined use of heparin and tirofiban during PCI
Other Name: brand name of tirofiban: Xinweining
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696110
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|Principal Investigator:||Yaling Han, MD||Shenyang Northern Hospital,China|