NCT03822975

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,016 (actual)
• Sponsor: Shenyang Northern Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Bivalirudin	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.
DRUG	unfractionated Heparin	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.

Timeline

• Start date: 2019-02-14
• Primary completion: 2022-05-07
• Completion: 2023-05-06
• First posted: 2019-01-30
• Last updated: 2025-08-27

Locations

85 sites across 1 country: China