drugset / Trial / NCT06861374
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | 1.75 mg/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | 60 iu/kg | Intravenous |
| Comparator | Heparin | Other / unclassified | 70 iu/kg | Intravenous |