Reduce Bolus Injection of Bivalirudin

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.

Timeline

Start

2019-10-01

Primary completion

2021-06-26

Completion

2021-06-26

Outcome

Met primary endpoint

paper both above the preset non-inferiority criterion of -0.07, establishing the non-inferiority. PMID 35548446 ↗

Publications

• Hu Q, Han YL, Zhou TN, Wang XZ, Zhang QY. Efficacy and Safety of the Reduced Bivalirudin in Patients Undergoing Coronary Angiography or Percutaneous Coronary Intervention Stratified by Renal Function (REDUCE BOLUS): A Single-Blind, Stratified Randomized, Non-inferiority Trial. Front Cardiovasc Med. 2022 Apr 25;9:864048. doi: 10.3389/fcvm.2022.864048. eCollection 2022.

Drugs

Indications