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

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.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

This protocol describes a prospective, open-label, randomized non-inferiority trial in 2510 high-bleeding-risk ACS patients undergoing elective PCI, comparing low-dose (80% of standard) versus standard bivalirudin infusion, with net adverse clinical events at 30 days as the primary endpoint.

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