NCT03588611

Reduce Bolus Injection of Bivalirudin

The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Han Yaling, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority, randomized, stratified controlled trial study has been conducted to evaluate the non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients with or without CKD.This study will provide a safe, effective and economical anticoagulation strategy.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Bivalirudin	0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
DRUG	Bivalirudin	0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-06-26
• Completion: 2021-06-26
• First posted: 2018-07-17
• Last updated: 2021-08-09

Locations

1 site across 1 country: China