This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6,016
Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is \>225 seconds.
Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is \>225 seconds.
Composite of all-cause death or BARC type 3~5 bleeding
BARC=Bleeding academic research consortium
Time frame: 30 days
All cause mortality
Time frame: 30 days
BARC type 3-5 bleeding
BARC=Bleeding academic research consortium
Time frame: 30 days
Major adverse cardiac and cerebral events (MACE)
MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
Time frame: 30 days
Net adverse clinical events (NACE)
NACE is defined as a composite of MACE or BARC type 3-5 bleeding
Time frame: 30 days
Composite of all-cause death or BARC type 2-5 bleeding
BARC=Bleeding academic research consortium
Time frame: 30 days
BARC type 2-5 bleeding
BARC=Bleeding academic research consortium
Time frame: 30 days
Stent thrombosis
Definite or probable stent thrombosis according to Academic Research Consortium
Time frame: 30 days
Thrombocytopenia
defined as platelet counts less than 150\*10\^9/L after treatment
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The First Hospital of Anhui University of Science&Technology
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Suzhou Municipal Hospital
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...and 75 more locations
Time frame: 30 days
All cause mortality
Time frame: 1 years