Phase 3 Trial of VMX-C001 vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.

Summary

The goal of this clinical trial is to learn if VMX-C001 works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that carry a high risk of bleeding. The main question it aims to answer is: ● What is the proportion of participants in whom the stopping of bleeding was classed as good or excellent during the procedure, as judged by a group of experts who did not know which treatment was given? Researchers will compare a fixed dose of VMX-C001 to the usual treatment that would be given for the required procedure. Participants will: * Be given either a fixed dose of VMX-C001 or usual treatment before they undergo the required procedure in theatre * Have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure * Return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted.

Timeline

Start

2026-03

Primary completion

2029-01

Completion

2031-01

Drugs

Indications