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.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 AMI patients undergoing percutaneous coronary intervention (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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,194
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
heparin monotherapy
combined use of heparin and tirofiban during PCI
Net Adverse Clinical Events
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
Time frame: 30 days
Net adverse clinical events
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
Time frame: 1 year
any bleedings (BARC class)
including all BARC class (class 1-5)
Time frame: 30 day
Major adverse cardiac and cerebral events (MACCE)
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Time frame: 30 days and 1 year
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1 st Hosp. of Anhui Med Univ.
Hefei, Anhui, China
Anhui Provincial Hosp.
Hefei, Anhui, China
3rd Hosp. of Beijing Univ.
Beijing, Beijing Municipality, China
Beijing Anzhen Hosp.
Beijing, Beijing Municipality, China
Beijing CAPF General Hosp.
Beijing, Beijing Municipality, China
Beijing Chaoyang Hosp.
Beijing, Beijing Municipality, China
Beijing Friendship Hosp.
Beijing, Beijing Municipality, China
Beijing General Hosp. of PLA
Beijing, Beijing Municipality, China
Beijing Hosp.
Beijing, Beijing Municipality, China
Beijing Luhe Hosp.
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...and 71 more locations