This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.
Any age
STEMI patients received fibrinolysis therapy within 12h of symptom onset and are planned to undergo PCI within 24h of symptom onset.
Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor)
Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
Not suitable for PCI;
Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
Cardiogenic shock(Killip IV)
Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
Parallel
Bivalirudin
DrugFor rescued PCI, do not recommend to include patient who's ACT is more than 350s. If fibrinolysis is successful, monitor ACT and wait till it's lower than 350s before randomization. Monitor ACT before angiography, (1) if ACT\<180, bivalirudin 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; (2) if 180s\<ACT\<225s, bivalirudin 0.5mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI; (3) if ACT\>225s, bivalirudin intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. (4) ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s, intravenous injection of 0.3 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is \>225 seconds.
Unfractionated heparin
Drug(1)If ACT\<180s, administer an intravenous bolus of unfractionated heparin at 70 U/kg before coronary angiography, with a maximum total dose of 6000U. (2)If 180\<ACT\<225s, administer an intravenous bolus of unfractionated heparin at 60 U/kg before coronary angiography, with a maximum total dose of 4000U. (3)If ACT\>225s, proceed directly with PCI and maintain 225s\<ACT\<350s.
Composite of all-cause death or BARC type 3、5 bleeding
BARC=Bleeding academic research consortium
All cause mortality
Composite of all-cause death or BARC type 2、3、5 bleeding
BARC=Bleeding academic research consortium
Net adverse clinical events (NACE)
NACE is defined as a composite of MACCE or BARC type 3、5 bleeding
Major adverse cardiac and cerebral events (MACCE)
MACCE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
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