Bivalirudin infusion at standard or low regimen during elective percutaneous coronary intervention in high-risk bleeding patients with acute coronary syndrome: Study protocol for a prospective, single-center, randomized controlled trial

Abstract

Background

Bleeding complications associated with anticoagulant therapy should receive more attention in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI), especially in those considered at high-risk bleeding. The recommended dosage of bivalirudin in clinical guidelines may not be appropriate for East Asian populations. We are performing a trial to investigate the efficacy and safety of a low bivalirudin regimen without prolonging infusion in high-risk bleeding patients with ACS undergoing elective PCI.

Methods

The study is a prospective, open-label, randomized controlled, non-inferiority trial. A total of 2510 patients will be enrolled and randomly (1,1) allocated to either receive the low (80 % of the standard dose) or standard bivalirudin regimen without prolonging the infusion after PCI. The primary endpoint is net adverse clinical events (NACE) at 30 days, which is a composite of major adverse cardiovascular and cerebrovascular events (MACCE, including all-cause death, repeat revascularization, stroke, nonfatal myocardial infarction, and stent thrombosis) and any bleeding events defined by the Bleeding Academic Research Consortium (BARC).

Conclusions

This proposed study is the first randomized controlled trial to evaluate the efficacy and safety of a low versus standard bivalirudin regimen during elective PCI in high-risk bleeding patients with ACS. The results may help achieve dose optimization for the use of perioperative bivalirudin in high-risk bleeding ACS patients undergoing elective PCI.

Trial registration

Chinese Clinical Trial Registry ChiCTR2200064363. Registered on October 4, 2022.