drugset / Trial / NCT06861374

Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

NCT06861374

Not yet recruiting 2400 enrolled First Affiliated Hospital Xi'an Jiaotong University
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2025-05
Primary completion
2028-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide 1.75 mg/kg Intravenous
Comparator Heparin Other / unclassified 60 iu/kg Intravenous
Comparator Heparin Other / unclassified 70 iu/kg Intravenous