Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

NANot yet recruitingINTERVENTIONAL
Enrollment

2,400

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2029

Conditions
ST-segment Elevation Myocardial Infarction (STEMI)
Interventions
DRUG

Bivalirudin

"For 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."

DRUG

Unfractionated heparin

(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.

All Listed Sponsors
lead

First Affiliated Hospital Xi'an Jiaotong University

OTHER

NCT06861374 - Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy | Biotech Hunter | Biotech Hunter